Lifelines for Health (vol 5): Follow the Heartline

Summer 2015 I Volume 5

A CHES Publication

Isn’t Home Infusion the Standard of Care for Hemophilia?

504 or IEP:

Making Sense of It - All!

Pilot Program Unveiled Men’s Inhibitor Retreat

The Pavri’s First Inhibitor Family Camp: The Painted Turtle HFA Annual Symposia 2015 Inhibitor Track is Back!

Everybody Gets to Have a Bad Day Once in Awhile

Breakthrough for Hemophilia B Patients: Novel Treatment Shows Great Promise Towards Long-lasting Solutions What Happened to SevenSECURE®?

LEVERAGE:

The Ultimate Inhibitor Adventure

Coming this Fall!

TOP-TEN: Ill-Advised Times/Places to Self-Infuse

In the last couple of years, I’ve been trying to travel a lot...

...and I really like traveling with NovoSeven® RT because it’s so small.

—Justin

JUSTIN Justin has congenital hemophilia with inhibitors Individual results may vary.

Indications and Usage

Warnings and Precautions

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for:

• NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT.

• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and people with Glanzmann’s thrombasthenia who have a decreased or absent response to platelet transfusions • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

Important Safety Information WARNING: BLOOD CLOTS • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported.

• Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function.

• Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT.

• Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.

• People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.

Be empowered to voice your treatment choice. How might NovoSeven® RT work for you?

Room temperature stable up to 77°F

Prefilled syringe means no extra steps to fill a syringe with diluent

Everything you need to prepare and mix in 1 small box

Justin and others share their thoughts at NovoSevenRT.com/SpeakUp

Side Effects • The most common and serious side effects are blood clots.

• Tell your healthcare provider about any side effects that bother you or do not go away.

Use with Other Drugs • Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).

Please see Brief Summary of Prescribing Information on the following page.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

NovoSeven® RT is a prescription medicine. Novo Nordisk provides patient assistance for those who qualify. Please call 1-877-NOVO-777 (1-877-668-6777) to learn more about Novo Nordisk assistance programs.

Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A. NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2015 Novo Nordisk All rights reserved.

0515-00026901-1 July 2015

NovoSeven® RT Coagulation Factor VIIa (Recombinant) Rx only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: THROMBOSIS Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. [See Warnings and Precautions] INDICATIONS AND USAGE: NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for: Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets; Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia CONTRAINDICATIONS: None known.

WARNINGS AND PRECAUTIONS: Thrombosis: Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance. Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) and uncontrolled post-partum hemorrhage have an increased risk of developing thromboembolic events due to circulating tissue factor (TF) or predisposing coagulopathy [See Adverse Reactions]. Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic complications. These include, but are not limited to, patients with a history of coronary heart disease, liver disease, disseminated intravascular coagulation, post-operative immobilization, elderly patients and neonates. In each of these situations, the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of these complications. Monitor patients who receive NovoSeven® RT for development of signs or symptoms of activation of the coagulation system or thrombosis. When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, reduce the dose of NovoSeven® RT or stop the treatment, depending on the patient’s condition. Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis have been reported with NovoSeven® RT. Administer NovoSeven® RT only if clearly needed in patients with known hypersensitivity to NovoSeven® RT or any of its components, or in patients with known hypersensitivity to mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT, administer appropriate treatment and weigh the benefit/risks prior to restarting treatment with NovoSeven® RT. Antibody Formation in Factor VII Deficient Patients: Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity before and after administration of NovoSeven® RT. If the factor VIIa activity fails to reach the expected level, or prothrombin time is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. Laboratory Tests: Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis. Assays of prothrombin time (PT/INR), activated partial thromboplastin time (aPTT), and plasma FVII clotting activity (FVII:C), may give different results with different reagents. Treatment with NovoSeven® has been shown to produce the following characteristics: PT: As shown below, in patients with hemophilia A/B with inhibitors, the PT shortened to about a 7-second plateau at a FVII:C level of approximately 5 units per mL. For FVII:C levels > 5 units per mL, there is no further change in PT. The clinical relevance of prothrombin time shortening following NovoSeven® RT administration is unknown.

INR: NovoSeven® has demonPT (sec) PT versus FVII:C strated the ability to normalize 14 INR. However, INR values have 13 not been shown to directly 12 predict bleeding outcomes, nor has it been possible to demon11 strate the impact of NovoSeven® 10 on bleeding times/volume in 9 models of clinically-induced 8 bleeding in healthy volunteers who had received Warfarin, when 7 laboratory parameters (PT/INR, 6 aPTT, thromboelastogram) have 5 normalized. aPTT: While admin4 istration of NovoSeven® shortens 3 the prolonged aPTT in hemophilia A/B patients with inhibitors, 2 normalization has usually not 1 been observed in doses shown to 0 30 40 induce clinical improvement. Data 0 10 20 indicate that clinical improvement FVII:C (unit per mL) was associated with a shortening of aPTT of 15 to 20 seconds. FVIIa:C: FVIIa:C levels were measured two hours after NovoSeven® administration of 35 micrograms per kg body weight and 90 micrograms per kg body weight following two days of dosing at two hour intervals. Average steady state levels were 11 and 28 units per mL for the two dose levels, respectively.

ADVERSE REACTIONS: The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia. Clinical Trials Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical

trials of a drug product cannot be directly compared to rates in clinical trials of another drug, and may not reflect rates observed in practice. Adverse reactions outlined below have been reported from clinical trials and data collected in registries. Hemophilia A or B Patients with Inhibitors: In two studies for hemophilia A or B patients with inhibitors treated for bleeding episodes (N=298), adverse reactions were reported in ≥2% of the patients that were treated with NovoSeven® for 1,939 bleeding episodes (see Table below).

Table: Adverse Reactions Reported in ≥2% of the 298 Patients with Hemophilia A or B with Inhibitors Body System # of adverse reactions # of patients Reactions (n=1,939 treatments) (n=298 patients) Body as a whole Fever 16 13 Platelets, Bleeding, and Clotting Fibrinogen plasma decreased 10 5 Cardiovascular Hypertension 9 6 Serious adverse reactions included thrombosis, pain, thrombophlebitis deep, pulmonary embolism, decreased therapeutic response, cerebrovascular disorder, angina pectoris, DIC, anaphylactic shock and abnormal hepatic function. The serious adverse reactions of DIC and therapeutic response decreased had a fatal outcome. There have been no confirmed reports of inhibitory antibodies against NovoSeven® or FVII in patients with congenital hemophilia A or B with alloantibodies. In two clinical trials evaluating safety and efficacy of NovoSeven® administration in the peri-operative setting in hemophilia A or B patients with inhibitors (N=51), the following serious adverse reactions were reported: acute post-operative hemarthrosis (n=1), internal jugular thrombosis adverse reaction (n=1), decreased therapeutic response (n=4) Congenital Factor VII Deficiency: Data collected from the compassionate/emergency use programs, the published literature, a pharmacokinetics study, and the Hemophilia and Thrombosis Research Society (HTRS) registry showed that 75 patients with Factor VII deficiency had received NovoSeven®: 70 patients for 124 bleeding episodes, surgeries, or prophylaxis; 5 patients in the pharmacokinetics trial. The following adverse reactions were reported: intracranial hypertension (n=1), IgG antibody against rFVIIa and FVII (n=1), localized phlebitis (n=1). As with all therapeutic proteins, there is a potential for immunogenicity. Patients with factor VII deficiency treated with NovoSeven® RT should be monitored for factor VII antibodies. The incidence of antibody formation is dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NovoSeven® RT with the incidence of antibodies to other products may be misleading. Acquired Hemophilia: Data collected from four compassionate use programs, the HTRS registry, and the published literature showed that 139 patients with acquired hemophilia received NovoSeven® for 204 bleeding episodes, surgeries and traumatic injuries. Of these 139 patients, 6 patients experienced 8 serious adverse reactions. Serious adverse reactions included shock (n=1), cerebrovascular accident (n=1) and thromboembolic events (n=6) which included cerebral artery occlusion, cerebral ischemia, angina pectoris, myocardial infarction, pulmonary embolism and deep vein thrombosis. Three of the serious adverse reactions had a fatal outcome.

Glanzmann’s Thrombasthenia: Data collected from the Glanzmann’s Thrombasthenia Registry (GTR) and the HTRS registry showed that 140 patients with Glanzmann’s thrombasthenia received NovoSeven® RT for 518 bleeding episodes, surgeries or traumatic injuries. The following adverse reactions were reported: deep vein thrombosis (n=1), headache (n=2), fever (n=2), nausea (n=1), and dyspnea (n=1). Postmarketing Experience: The following adverse reactions have been identified during post approval use of NovoSeven®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.

Table: Post Marketing Experience MedDRA System Organ Preferred Term Class Immune system disorders Hypersensitivity (including anaphylactic shock, flushing, urticaria, rash, angioedema) Vascular disorders Thromboembolic events (including hepatic artery thrombosis, myocardial infarction, cerebral infarction, intestinal infarction, intracardiac thrombus, peripheral ischemia, portal vein thrombosis, myocardial ischemia, renal artery thrombosis) OVERDOSAGE: Dose limiting toxicities of NovoSeven® RT have not been investigated in clinical trials. The following are examples of accidental overdose. One newborn female with congenital factor VII deficiency was administered an overdose of NovoSeven® (single dose: 800 micrograms per kg body weight). Following additional administration of NovoSeven® and various plasma products, antibodies against rFVIIa were detected, but no thrombotic complications were reported.

One Factor VII deficient male (83 years of age, 111.1 kg) received two doses of 324 micrograms per kg body weight (10-20 times the recommended dose) and experienced a thrombotic event (occipital stroke). One hemophilia B patient (16 years of age, 68 kg) received a single dose of 352 micrograms per kg body weight and one hemophilia A patient (2 years of age, 14.6 kg) received doses ranging from 246 micrograms per kg body weight to 986 micrograms per kg body weight on five consecutive days. There were no reported complications in either case.

More detailed information is available upon request.

For information contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, USA, 1-877-NOVO-777, www.NovoSevenRT.com Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark Novo Nordisk® is a registered trademark of Novo Nordisk A/S. NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. © 2014 Novo Nordisk 0614-00021853-1 7/14

Letter From the Editors As if having a child with hemophilia and an inhibitor doesn’t test your resiliency, this past winter’s snow in the Boston area tested all of those resiliency reserves! As I met people from across the country and they asked, “Was it as bad as it looked”, my response has been, “No, it was worse”! There were times we literarily could not see out of the windows! So it is with great pleasure that Eric and I say welcome to the SUMMER issue of the only newsletter dedicated to the inhibitor community! We are thrilled to continue providing information that is pertinent and specific to your lives. As individuals who live with hemophilia and an inhibitor, we understand the challenges, struggles and concerns that are very different than having “just hemophilia”. So many of you have faced some very challenging hospitalizations since our last publication and we wish that we all lived closer to help one another out.

A special recognition to the following as the official ancillary donors for selfinfusion classes for Inhibitor Family Camp -

As families who live with a chronic illness, loss is an everyday part of our lives. Lost expectations that our world will ever be “normal” again, plans excitedly made-cancelled. During Inhibitor Family Camp this spring at The Painted Turtle, we were fortunate to have Russell Friedman, co-author of The Grief Recovery Handbook, When Children Grieve, and Moving On as a guest speaker. He presented on the 6 Myths of Grief while each one of us in the room nodded as we recognized well-meaning words we have heard and said to soothe those feelings of loss. His feature article will resonate within all of us.

In our Community Chatter section, as always we bring you news of events and programs specific to the inhibitor community written by community members. Our BloodLines section features summary information regarding a study published in 2011 in the New England Journal of Medicine regarding a possible gene therapy cure for FIX. Could this really be in our future??

BioRx

In our Insurance Corner section a disturbing decision made by Novitas, a government oversight agency for Medicare/Medicaid determined that patients who infuse FVII must now do so in a hospital setting in thirteen different states. Yes, you are reading this correctly.

This decision sets our standard of treatment so greatly fought for, back over 40 years. Have you been impacted by this? We would like to hear from you.

Ever have one of those moments when everything seems to be going along “normally” (even though we are always waiting for the other shoe to drop), and suddenly there are shouts and angry words spewing through the air? In Family Matters, we address the how, why and what to do when that moment erupts in your home. We have introduced a new section in LifeLines for Health for 2015 titled What’s the Plan? In this first article, the differences between the two federal laws designed to protect the rights of those with a disability are defined.

The Fun and Inspiration section is meant to provide the levity and triumphs we need and to celebrate as we navigate this sometimes-bumpy path called our lives.

We hope that the summer is filled with uneventful days of swimming, toes in the sand or just plain doing nothing but watching the clouds. Have an idea, comment or suggestion? We always love to hear from you!

- Janet Brewer & Eric Lowe “So, this is my life. And I want you to know that I am both happy and sad and I’m still trying to figure out how that could be.”

-Stephen Chbosky, The Perks of Being a Wallflower jbrewer@comphealthed.com l elowe@comphealthed.com

LifeLines for HealthSM Disclaimers The views and opinions of our writers are not a reflection of Comprehensive Health Education ServicesTM, Inc. (CHES), or its’ sponsors.

This newsletter is designed to provide a forum for community members to express their views from an open and honest platform. It is meant to provide a sharing of knowledge and experience meant to help one another. Nothing in this newsletter is meant to replace the advice of your HTC, medical professional team or insurance provider. You are always urged to seek the opinion of a healthcare professional for treatment and your specific insurance provider for information.

We take your privacy very seriously. We would never disclose your personal health information without your express written consent. We would never sell nor make available our secure database to anyone.

Articles and pictures may not be reproduced, published, and/or placed on websites without the express written permission of CHES. In every publication of LifeLines for HealthSM, we will provide links to other websites that are not owned or controlled by CHES or its sponsors. We cannot be responsible for privacy practices of other website owners, nor can we be responsible for the accuracy of the information provided.

Integrity, Accuracy, Empathy...

CONTENTS

FEATURE 14 I Follow the Heartline

It’s only natural to associate grieving with death. But why do we not extend this same feeling to other losses in our lives? All families experience a variety of loss; even more so for those that live with a chronic condition. Lost opportunities, expectations, and more all deserve some attention on your part.

Listen to your heart and both you and your family will be thankful that you did.

COMMUNITY CHATTER

INSURANCE CORNER

7 I Pilot Program Unveiled: Men’s Inhibitor Retreat

23 I Isn’t Home Infusion the Standard of Care for Hemophilia?

This spring, CHES launched a new program created for adult males with inhibitors to provide smart choices, self-reliance, and best of all, a unique opportunity to meet others.

8 I The Pavri’s First Inhibitor Family Camp: The Painted Turtle Meet the Pavri’s as they take you through their day-to-day experience at their first Inhibitor Family Camp.

10 I HFA Annual Symposia 2015: Inhibitor Track is Back!

A MUST READ! - Depending on place of residency and infusion product, some of us have lost our right to self-infuse. If we don’t want this problem to persist or grow, we must stay informed and fight for our rights.

FAMILY MATTERS 28 I Everybody Gets to Have a Bad Day Once in Awhile

As the prevalence of inhibitors grows, the Hemophilia Federation of America continued its’ Inhibitor Track for the second, consecutive year to focus more support on this uprising group.

Everyone has a bad day, and maybe this day is yours! Dr. Gary McClain has some suggestions for us all to keep the peace in our home and within.

BLOODLINES

FUN & INSPIRATION

32 I Breakthrough for Hemophilia B Patients: Novel Treatment Shows Great Promise Towards Long-lasting Solutions

35 I Top-Ten: Ill-Advised Times/Places to Self-Infuse

We’ve been hearing it for years, decades even that gene therapy is our cure. But perhaps gene therapy for treatment is the next step to bridge our gap to a cure. Read about these impressive results!

What’s the Plan?

34 I What Happened to SevenSECURE®?

Novo Nordisk has phased out their patient assist program known as SevenSECURE® and replaced it with NovoSecureTM. What this means for the patient...

34 I Alphanate®, More is Less

36 I 504 or IEP: Making Sense of It - All! With over 20 years of experience in the world of special education, Janet Brewer, M.Ed explains what these school education plans are so you can determine which is the right choice for your child.

New product update could make life a little easier.

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LIFELINES for HEALTH

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Summer 2015

CONTENTS

Puzzling Cases?

Achieve response with the power and stability of the FVIII/vWF Complex*

FVIII

von Willebrand

Koate ˉ ®-DVI1,2: * Ko ate ˉ ®-DVI has not been investigated • Is indicated for the treatment of classical for efficacy in the treatment of von Willebrand disease, and hence hemophilia A is not approved for such usage • Demonstrates a mean biologic half-life of 16.12 hours ** A total of 306 bleeding episodes were • Contains naturally occurring vWF* treated. 82% of the bleeding episodes • Is well-tolerated with low risk (0.7%) of adverse reactions were treated adequately with a single infusion of FVIII • Is effective in a single dose** Important Safety Information Koate ˉ ®-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.

When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored for signs of progressive anemia. ©2014 Kedrion Biopharma, Inc. All Rights Reserved. Printed in USA June 2014 KT-0077-00-2014

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see next page for Brief Summary of Koate ˉ ®-DVI Product Information. For Full Product Information, please visit www.koate-dviusa.com.

References: 1. Koate ˉ ®-DVI [prescribing information]. 2012. 2. Powell JS, Bush M, Harrison J, Abildgaard C, Vosburgh E, Thompson AR, Hurst D. Safety and efficacy of solvent/detergent- treated antihaemophilic factor with an added 80 degrees C terminal dry heat treatment in patients with haemophilia A. Haemophilia. 2000;6(3):140-9.

Koˉate®-DVI [Antihemophilic Factor (Human)] Brief Summary: Please see Koate ˉ ®-DVI Full Prescribing Information for complete product details.

Koate ˉ ®-DVI [Antihemophilic Factor (Human)] is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, Factor VIII) used to treat classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, Factor VIII. Koate-DVI ˉ contains naturally occurring von Willebrand factor, but has not been approved for the treatment of von Willebrand disease.

Warnings Koate-DVI ˉ is made from human plasma. It may contain infectious agents that can cause disease, such as viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that the product will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Despite these measures, the product may carry a risk of transmitting infectious agents, including unknown infectious agents.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. Hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.

Precautions Koate-DVI ˉ is intended for the treatment of bleeding disorders arising from a deficiency in Factor VIII. This deficiency should be proven prior to administering Koate-DVI. ˉ Koate-DVI ˉ should be administered within 3 hours after reconstitution and should not be refrigerated after reconstitution. Administer only by the intravenous route, and use a filter needle prior to administering.

Koate-DVI ˉ contains levels of blood group isoagglutinins, which are not clinically significant when controlling relatively minor bleeding episodes. When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored by means of hematocrit for signs of progressive anemia, as well as by direct Coombs’ tests.

Product administration and handling of the infusion set

and needles must be done with caution. Place needles in sharps container after single use and discard all equipment including any reconstituted Koate-DVI ˉ product in accordance with biohazard procedures. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time.

Parvovirus B19 most seriously affects pregnant women and immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about 2 weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly.

Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.

Pregnancy Category C Animal reproduction studies have not been conducted with Koate-DVI. It is also not known whether Koate-DVI ˉ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koate-DVI ˉ should be given to a pregnant woman only if clearly needed.

Pediatric Use Koate-DVI ˉ has not been studied in pediatric patients.

However, the previous formulation, Koate-HP, ˉ had been used extensively in pediatrics. Spontaneous adverse event reports with Koate-HP ˉ for pediatric use was similar to those reported for adult use.

Adverse Reactions Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.

In clinical studies, 0.7% of infusions were associated with adverse reactions. All reactions were mild and included paraesthesia (numbness), blurred vision, headache, nausea, abdominal pain, and feeling jittery.

The information provided in this brief summary should not replace a conversation with your physician. It is important to talk to your physician about treatments that are appropriate for you.

For Koate ˉ ®-DVI Full Prescribing Information, please visit www.koate-dviusa.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

an Innovative CHES Program

New Pilot Program Unveiled A Patient’s Perspective

T

he recent Men’s Inhibitor Retreat, hosted by Comprehensive Health Education Services with an educational grant from Kedrion, held at the Excalibur Hotel in Las Vegas on April 24-27, 2015, was very informative and definitely worth attending. Not only did I learn some things, I also created new friendships! It’s always nice to connect with

(L to R) Royal Smith, James White, Lexington Fladager, & Rodney Dalrymple

others within our inhibitor family. Sometimes the most important things that I learn come from others with inhibitors. Yes, the professionals will provide important information that is useful, but by talking to others about their own experiences, resources, etc., is also helpful.

The first night in Vegas, most of us were there for supper and a social, and it was a nice way to meet people in a relaxed setting; the entire weekend was a relaxed setting. Several people were especially impressed with their dessert - can’t go wrong with chocolate!

by Tom Sitzler

Saturday started early with a nice breakfast and more socializing. Throughout the day we had doctors and nurses talk to us about a variety of topics. The first presenter, Dr. Mark Heiny from the Indiana Hemophilia and Thrombosis Center, spoke about different treatment options. I especially liked that he didn’t pressure us in what we should or shouldn’t be using for treatment. Our next presenter, Dr. Paul Bregman informed us of the use of medical cannabis/marijuana. He was very passionate and informative. The discussions brought up some very good questions and I learned a lot about this controversial treatment. I found it interesting that it can be made into a cream or oil. The CBD (cannabidiol, an active ingredient in cannabis) cream could be helpful during a bleed as an anti-inflammatory, and I wouldn’t be against trying it, especially if it helps with some joint relief.

After an enjoyable lunch, we learned some valuable lessons on how to access veins easier. Who knew that a strong LED flashlight can help you locate a vein? That was a nice tip!

Saturday night was full of fun. We all went to the Monte Carlo Hotel for dinner and a show. After dinner we went to Blue Man Group. I can’t think of a better way to end an evening. They put on a great show; I would go see them again! Sunday morning we had breakfast and time for more relationship building. Our last presenter, Don Molter from the Indiana Hemophilia and Thrombosis Center, spoke about career counseling. This was a good opportunity for people to learn about various funding sources for college and how to pick a career that is a good fit for you. He stressed the importance of picking a career that is suitable to our interests and limitations. Overall, this was a great weekend. We had an opportunity to become more educated, meet new people, and create some nice memories.

Learn more at: comphealthed.com Notification sign-up is available if you’d like to receive updates.

This program was sponsored by Kedrion Biopharma.

Tom Sitzler is an adult with hemophilia and an inhibitor. He is a vocational counselor in his home state of South Dakota where he lives with his wife Shirley. Tom has served on manufacturer’s Consumer Councils and is a frequent attendee at Inhibitor Summits.

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COMMUNITY CHATTER

The Pavri’s First Inhibitor Family Camp:

“The Painted Turtle”

D

ay 1: Our very excited wait came to an end when we boarded the plane to California in April, for the first time, to attend Inhibitor Family Camp at The Painted Turtle. After a long trip from New Jersey to California, we boarded a bus which took around two hours to get to the venue. The route leading to camp was very scenic.

As soon as our bus entered the premises, our Yasmin with son, Porus (10) Camp Director, April was there, all dressed up, to welcome us. She seemed more excited than any of the participants. Her excitement and enthusiasm could make even an antisocial person come alive!

D

We were dropped off near our cabins. Ours was “Yellow 3”. A beautiful cabin that fit two or perhaps even three families. The cabins were very creative on the inside and had a beautiful welcome basket and kit ready for us.

There we also met our camp counselor. His name was Dave.

Such a fantastic person. His level of maturity made us feel very comfortable leaving our son with hemophilia and inhibitors with him. He was caring and went out of his way to see that our trip was all worth it.

The next person we met was a very interesting person. His name was “PUN”. He looked funny and spoke bone-tickling funny. He immediately made us feel comfortable and engaged us in some hilarious conversations. The one very outstanding quality that he had was remembering each and everyone’s names. How amazing is that? Some of us can’t remember the name of a friend or a neighbor we met two days back, but he was tremendous. He was the life and soul of the camp. Our family loved and adored him. A humble person by nature and someone who loves, simply loves kids.

Being our first camp experience, we didn’t know there were fixed times to eat and only a certain amount of minutes were given to complete your meal. It worked perfectly for parents who have fussy children that take over an hour to eat at home.

ay 2: Saturday morning we started our day with archery, ate breakfast, went horseback riding (met/saw some beautiful horses), did wood carving with POPS (made a turtle, the kids made their pine wood derby car and we also made a “PAVRI” sign key holder). Then we had lunch and the adults went for an education session while the kids had a blast with their camp counselors and enjoyed blasting rockets.

After that we went fishing, had dinner and enjoyed some restful quiet time.

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Written by: Farah and Porus Pavri Edited by: Yasmin Pavri

D

ay 3: By now we were a bit tired so we missed the early morning activity which we can go to before breakfast. After breakfast, we went boating, did some arts and crafts, had lunch, and the kids had a lovely time playing on the huge chess board. Later we attended a beautiful session on how to keep calm when you are in the middle of a bleed. We also learned that we must be kind and loving to the part of the body that is bleeding instead of cursing and saying bad things about it. Then it was time for the main attraction of the camp. Ta na na na…. Ta na na na… The Pine Wood Derby organized by our very own POPS. Porus really wanted his car to win and was pretty disappointed when it was eliminated in the first round. L After dinner we enjoyed the talent show in which Farah participated and played the keyboard. We went to the camp store and picked up some souvenirs for ourselves and the kids enjoyed an awesome magic show by our very own Pun. ~

D

ay 4: Time to go home. Mrs. Pops had put together a wonderful presentation of family pictures and several other pictures taken at various activities which we saw. We had to pack and say goodbye to our friends, both old and new, and a goodbye to our cabin, and our swing outside our cabin, and the big chess board, and our wonderful counselors and friends and volunteers at the camp.

Thank you Janet, Eric and Joan for inviting us and giving us this beautiful camp experience that we had only been hearing of in the past. Our kids had a blast

and seeing t h e i r enjoyment gave us adults a very satisfying feeling. The environment was safe and the “Well Shell” took care of all our medical needs. Our kids still have and love their turtle pillows. Porus has “Lee” written on his and remembers his new buddy Lee fondly when he cuddles up

Farah showing off her pianist skills at the final night talent show

with the pillow. We really look forward to coming back and having the same fun each year.

an Innovative CHES Program

Everyone deserves a camp to call their own This program is specially designed to meet the needs and limitations of children with both, hemophilia & inhibitors. Immediate family members are also invited because we understand that chronic illness affects the whole family. We play, learn, and grow while we build a stronger community.

To register, applicants must have an active inhibitor, or a history of an inhibitor within the last 12 months, and are between the ages of 6-19. If you’re interested, please act now. Space is limited, and slots are filled on a first come, first-served basis for those who qualify.

Supported by an educational grant from

SPRING SESSION

Date: ENDED (Friday, April 10th - Monday, April 13th) Loction: The Painted Turtle, located in Lake Hughes, CA Registration Opens: Friday, January 9th, 2015

FALL SESSION

Date: Friday, Oct. 16th - Monday, Oct. 19th Loction: Victory Junction, located in Randleman, NC Registration Opens: Wednesday, July 1st, 2015

Presented by

Learn more at InhibitorFamilyCamp.org

COMMUNITY CHATTER

HFA Annual Symposia 2015:

Inhibitor Track is Back!

by Harpreet Maan

T

he Hemophilia Federation of America has truly exceeded expectations with their annual education event this year! All the resources and time they invested into the annual symposium simply made it a memorable experience. The majority of the first day was committed to the Inhibitor Track program exclusively centered on all aspects concerning inhibitors. They placed front and center the topics that matter most to our inhibitor community. They heeded all the advice from past participants feedback to bring us a great line up of speakers. This event was proof positive of HFA’s unyielding commitment to advancing education for all of us in the bleeding disorders community. Various issues were highlighted by each session, promising medical developments, post-traumatic growth, and grassroots advocacy, concluding with a panel chronicling inhibitors from the past to present.

It was truly a privilege to be able to witness first hand the excitement around the key issues, and I hope to give you some insight on their highpoints.

Shannon Meeks, M.D. (Photo courtesy of HFA)

Hemophilia A and Inhibitors Our first presenter was Shannon Meeks, M.D. who joined us all the way from Children’s Healthcare of Atlanta. Doctor Meeks presented on Hemophilia A and Inhibitors, spanning from proven methods of testing titers to best treatment options when it comes to immune

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tolerance and the use of bypass agents. I was heartened to hear the courageous stories of many families making long journeys across state border lines to see Dr. Meeks to obtain the latest care in combating their child’s inhibitor. Many in the room were in complete agreement with Dr. Meeks when she announced,

“inhibitors are the most significant complication of hemophilia in the developed world.” One of the more insightful statistics which Dr. Meeks highlighted was concerning the frequencies of inhibitor development; “Severe hemophilia A: 20-30%, Mild & moderate hemophilia A: 3%-13%, and Acquired hemophilia ~1.4 per million.” She went on to cover many different case profiles and the corresponding therapies with which she saw success in her clinic. When initiating immune tolerance therapy all aspects must be closely examined; attaining accurate titer tests, selecting the right immunosuppressive agents, FVIII products, and other adjunctive treatments to make certain you have all the right elements in play to ensure successful outcomes. The take home message was that there is no magic bullet that works across the board with equal efficacy for everyone when it comes to combating inhibitors; each immune tolerance regiment should be uniquely matched to the patient’s biomarkers for the best results. Dr. Meeks concluding message of optimism was centered on new bypass agents and extended life factors freshly on the market and those at the tail end of the pipeline that we will see soon to come. The passion that Dr. Meeks has for our community is truly palpable as evident in the many accolades she has received.

She still strives to do more and more each year to help advance inhibitor research and we are ever appreciative of her ongoing commitment.

Post-Traumatic Growth In the headlines, we hear about military related post-traumatic stress disorder (PTSD), and Dave Robinson, LMFT, Ph.D. covered how similar trauma affects we civilians as well in varying degrees.

Literature points to trauma typically entering our world following exposure to highly stressful events. This could be translated to our community as one really bad bleed and its’ related complications, or a whole slew of spontaneous bleeds.

find strength to see a new opportunity and to better our tomorrows. Coach Wooden kept it short and simple with his advice: “Do not let what you cannot do interfere with what you can do.” With PTG, some will say they have greater appreciation for life and take pleasure in things they had once simply taken for granted. There are many filters in which we can choose to see our current situation, selecting the more optimistic lens today is surely to bring into focus better future prospects that we can attain.

her son Matthew have done with their nonprofit Reduce Inhibitor Development (RID). Their mission is to decrease inhibitor development in our community through raising awareness, education, and encouraging more research. Debbie and her family have been involved in the hemophilia community for many years and notice a need for more awareness and research on inhibitors from how they are formed and how they can possibly be prevented. Debbie is passionate about the work she has done and hopes the major accomplishment for our community would be a future where there are no new inhibitor diagnoses. RID is making a difference by voicing our concerns while empowering us in the inhibitor community to always ask why, and ponder how more could be done.

Left unchecked, high frequency exposure to such stressful events overtime Reduce Inhibitor Development (RID) may lead to psychological distress and We have found that in the past the possibly seeding future development of best vehicle to voice our concerns and to psychiatric conditions unless we have the mobilize change usually has its origins right tools and support. Dave stressed at the grassroots level, and that is just that we should not hesitate to reach out for the good work that Debbie Porter and help through your HTC or by scheduling a session with your local psychologist.

The Inhibitor track concluded with a panel presentation comprised of some of the previous The other side of the coin presenters from the morning along with other notable experts in the field. They reviewed the of this trauma story is a topic significant historical developments, improvements in the knowledge base, and improvements that I’m particularly elated in the available treatment of inhibitors throughout the years. They discussed how testing for about and it’s the positive inhibitors has improved in the last few decades which has allowed for better data collection. experiences and psychological Some interesting statistics were presented on the measurable rates of inhibitors in our hemophilia changes that are realized A population; starting back from 1974 where there was a reported rate around 5-10%, in 1987 the from persisting through rate was 10-15%, and in 2008 it was 20-33%. It is disconcerting to hear that 1-in-3 of us today the struggle, also known as post-traumatic growth (PTG).

Prevalence of Individuals with Inhibitors There is exciting research on how PTG may change life for the better in countless ways; Personal Strength, Relating to Others, Spiritual Change, Appreciation of Life, and New Possibilities. Yes! So, as soon as you heal from your bad bleed you can ignore your hematologist’s advice on sticking to golf and now go join the NFL (certainly NOT recommended). Perhaps it’s more probable that you can go to college for sports journalism and then go on to one day possibly land your alternate dream job as a sports in the hemophilia A population are likely to face the challenges of living with an inhibitor. Yes, announcer for ESPN. The we have come a long way from treating our bleeds with cryo and ice, but there is still the whole word “resilience” comes to area of inhibitors, which needs a better-illuminated path where we can certainly do more for our mind as a key trait seen in community. I encourage everyone who is able to find the time and opportunity to attend the next our community that allows us HFA annual meeting in Las Vegas, March 31st – April 2nd, I look forward to meeting you there! to face many challenges and

COMMUNITY CHATTER

MORE FREEDOM TO REDUCE BLEEDS FEWER BLEEDS1 FEIBA routine prophylaxis may help you have more options and more bleed-free days, as compared to on-demand treatment.

A clinical study showed*

FEWER BLEEDS1 7.9 median ABR with prophylaxis treatment vs 28.7 median ABR with on-demand treatment

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FEWER JOINT BLEEDS2 ABR for joint bleeds was reduced from 22.9 in the on-demand arm to 6.0 in the prophylaxis arm

*The FEIBA PROOF clinical study was a multicenter, open-label, randomized prospective clinical trial of 36 hemophilia A and B patients with inhibitors receiving FEIBA for prophylaxis or on-demand treatment for 12 months. 196 bleeding episodes occured during prophylaxis treatment vs. 629 during on demand treatment.

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FEWER

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DECREASE IN NEW TARGET JOINTS

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Indications for FEIBA Coagulant Complex] JOINT[Anti-Inhibitor BLEEDS2

DECREASE IN NEW TARGET JOINTS2,ns

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Use around the time of surgery • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex] WARNING: EVENTS INVOLVING CLOTS THAT BLOCK BLOOD VESSELS 2, ns been reported during postmarketing surveillance following infusion of FEIBA, particularly following • Blood clots that block blood vessels and their effects have the administration of high doses and/or in patients with a risk of forming blood clots.

• If you experience any of these side effects, call your doctor right away.

You should not use FEIBA if: • You had a previous severe allergic reaction to the product (reactions causing discomforts that are damaging and life threatening) • You have signs of development of small blood vessel clots throughout the body • You have sudden blood vessel clots or blocked blood vessels, (e.g., heart attack or stroke) Events involving blood clots blocking blood vessels can occur with FEIBA, particularly after receiving high doses and/or in patients with risk factors for clotting.

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg of body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

At first sign or symptom of a sudden blood vessel clot or blocked blood vessel (e.g., chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain), stop FEIBA administration promptly and seek emergency medical treatment.

Allergic-type hypersensitivity reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. If you experience any of these signs or symptoms, stop FEIBA administration immediately and seek emergency medical treatment.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most frequent side effects observed during the prophylaxis trial were anemia, diarrhea, bleeding into a joint, signs of hepatitis B surface antibodies, nausea, and vomiting.

The serious side effects seen with FEIBA are allergic reactions and clotting events involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

Call your doctor right away about any side effects that bother you during or after you stop taking FEIBA. Please see brief summary of FEIBA Prescribing Information on next page.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

1.

2.

FEIBA Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; November 2013.

Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia.

2013;20:65-72.

Baxter and Feiba are registered trademarks of Baxter International Inc. February 2015 USBS/145/15-0006

FEIBA [Anti-Inhibitor Coagulant Complex] For Intravenous Use, Lyophilized Powder for Solution Brief Summary of Prescribing Information. Please see package insert for full Prescribing Information.

WARNING: THROMBOEMBOLIC EVENTS • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

• Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Perioperative management • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. CONTRAINDICATIONS • Known anaphylactic or severe hypersensitivity reactions to FEIBA or any if its components, including factors of the kinin generating system.

• Disseminated intravascular coagulation (DIC).

• Acute thrombosis or embolism (including myocardial infarction).

WARNINGS AND PRECAUTIONS Thromboembolic Events Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors [see ADVERSE REACTIONS].

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events.

Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity Reactions Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

Transmission of Infectious Agents Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, and the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk has been minimized by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and removing certain viruses during the manufacturing process [see DESCRIPTION in full Prescribing Information]. Despite these measures, the product may still potentially transmit human pathogenic agents.

There is also the possibility that unknown infectious agents may still be present.

All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare providers to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.) and /or to FDA Med Watch (1-800-FDA-1088 or www.fda.gov/medwatch).

ADVERSE REACTIONS The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety assessment of FEIBA is based on the review of the data from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes and a prospective trial that compared the use of FEIBA prophylactically versus on-demand treatment.

The adverse reactions reported from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes were chills, chest pain, chest discomfort, dizziness, dysgeusia, dyspnea, hypoesthesia, increase of inhibitor titer (anamnestic response), nausea, pyrexia, and somnolence. Specifically, the first trial was a multicenter randomized, double-blind trial in 15 hemophilia A subjects with inhibitors to factors VIII. The second trial was a multicenter FEIBA study conducted in 44 hemophilia A subjects with inhibitors, 3 hemophilia B subjects with inhibitors and 2 acquired factor VIII inhibitor subjects. Of the 489 infusions used to treat acute bleeds during the second trial, 18 (3.7%) caused minor transient reactions of chills, fever, nausea, dizziness and dysgeusia. Out of 49 subjects, 10 (20%) had a rise in their inhibitor titers after treatment with FEIBA. Five of these subjects (50%) had increases that were, tenfold or more, and 3 (30%) of these subjects received factor VIII or IX concentrates within 2 weeks prior to treatment with FEIBA. These anamnestic rises were not associated with decreased efficacy of FEIBA. Table 2 lists the adverse reactions in >5% of subject reported in the randomized, prospective prophylaxis trial comparing FEIBA prophylaxis with on-demand treatment in 36 hemophilia A and B subjects with inhibitors to factors VIII or IX. The trial population included 33 (92%) subjects with hemophilia A and 3 (8.3%) subjects with hemophilia B. Four (11%) subjects were ≥7 to <12 years of age, 5 (14%) were ≥12 to <16 years of age, and 27 (75%) were ≥16 years of age. A total of 29 (80.6%) subjects were Caucasian, 3 (8.3%) Asian, 2 (5.6%) Black/African American, and 2 (5.6%) other. The subjects received a total of 4,513 infusions (3,131 for prophylaxis and 1,382 for on-demand). Adverse reactions were defined as adverse events that occurred (a) within 24 hours after being infused or (b) adverse events assessed related or possibly related or (c) adverse events for which the investigator’s or sponsor’s opinion of causality was missing or indeterminate.

Table 2 Prophylaxis Study Adverse Reactions (ARs) in >5% of Subjects MedDRA System Organ Class Blood And Lymphatic System Disorders Gastrointestinal Disorders Investigations Musculoskeletal And Connective Tissue Disorders

Preferred Term

Number Number of of ARs Subjects

Percent of Subjects (N=36)

Anemia

2

2

5.6

Diarrhea Nausea Vomiting Hepatitis B Surface Antibody Positive

2 2 2

2 2 2

5.6 5.6 5.6

4

4

11.1

Hemarthrosis

5

3

8.3

Post-Marketing Experience Because post-marketing reporting of adverse reactions is voluntarily and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: disseminated intravascular coagulation CARDIAC DISORDERS: tachycardia, flushing RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: bronchospasm, wheezing GASTROINTESTINAL DISORDERS: abdominal discomfort SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: malaise, feeling hot, injection site pain DRUG INTERACTIONS Concomitant Medications Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and wellcontrolled studies of the combined or sequential use of FEIBA and recombinant factor VIIa or antifibrinolytics have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Baxter and Feiba are trademarks of Baxter AG, Vienna, Austria. Baxter, Feiba and Baxject are trademarks of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation, Westlake Village, CA 91362 USA U.S. License No. 140 Issued Nov 2013 USBS/145/14-0043

By Russell Friedman

Moms: “Do you remember how you felt in the moment you first became aware that you were pregnant with your child?”

Dads: “Do you remember how you felt in the moment your wife first let you know that she was pregnant with your child?”

W

e know that every parent, from that moment of awareness of a coming child, begins to create hopes, dreams, and expectations about the future. Every one of the images they conjure up is glorious, uplifting, and happy. “My child will be brilliant, a great artist, a gifted athlete, socially gracious, and will of course be of service to humanity and do great works of charity.” It may sound a little overblown, but you know what we mean.

Many expectant parents vow that they will do “right” the things their own parents did “wrong.”

They will love and cherish their children in better ways, so that their lives will be better.

The pledge we each make is that our children will have a better life than we had, no matter how good [or bad] our life and circumstances have been.

Some people, who had ideal childhoods [we’ve actually met a few], make a commitment to recreate and even improve the kind of loving atmosphere and treatment they recall from their youth.

THE THIRD QUESTION

The two questions that opened this article were asked in a speech we made to a group of parents

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Follow the Heart Line

who were at the first annual convention of an organization that had nothing to do with hemophilia. It was a group whose common linkage was that each member had a child, or children, who were bound up in the tentacles of drug or alcohol addiction.

None of them had imagined they would wind up in that hotel conference room 15 or 20 years after their child’s birth.

Nor that they would be with nearly one thousand other parents that weekend whose hopes, dreams, and expectations had also been dashed on the rocks of a condition that wreaks havoc on all who are caught in its wake.

Like them, we imagine that you never thought in the moment you learned you were going to have your child, that one day you would be reading an article like this.

There was also a third question we needed to ask. It was an awkward one: “How many of you are still married to the co-parent of the child whose condition caused you to be here?” The limited showing of hands indicated a divorce rate much higher than the national average.

Dealing with situations that are outside the range of normal puts inordinate pressure on marriages.

Hemophilia, and later, the complication of inhibitors, undoubtedly affect everyone concerned to their emotional cores. Along with that, each family member brings their own beliefs and feelings to the painful task of dealing with the massive loss of shattered hopes and dreams.

Many people carry forward the emotional reactions they had to other grief-related events that affected their lives. Like most of us, rather than being taught how to effectively grieve and complete their relationship to what had happened, they learned to bypass those feelings, to bury them out of sight and out of mind.

But the reality is that if you don’t deal with those feelings, eventually they will deal with you, and potentially, with some very negative consequences. Until you deal effectively with the emotions that you may have stored, it can be exponentially

difficult to deal with the ongoing emotions that are constantly provoked by living with a condition that requires 24/7 hypervigilance. In guiding people who must deal with the daily confrontation of an ongoing condition, we have helped a great number of them not become divorce statistics. We will pass some of that help on to you in this article.

MY GET UP AND GO, GOT UP AND WENT Our experience with grieving people suggests that there are two things that almost universally impact everyone whose lives have been affected by losses of all kinds. First, is they have a very hard time

concentrating, and second, is the ongoing grief drains energy. While this is typical in the early days following a death or divorce, it can be constant when dealing with a continuing situation, as is the case with parenting a child with hemophilia and an inhibitor.

The inability to focus or concentrate looks like this: You walk into a room to do something and then have no idea what you wanted to do when you get there. That’s just one example. We’re sure that you can think of other ways in which you have found it difficult to keep your mind, body, heart, and soul all in the same place at the same time.

Having to be on high alert at all times is physically draining and emotionally exhausting.

Dealing with an ongoing condition that requires both physical and emotional attention tends to deplete our capacity to be most effective. We can feel as if we’ve been ground down to nothing.

FEATURE

Because of the potential for emotional exhaustion, we believe it essential that you learn how to deal with any emotions you’ve stored up over time, and how to deal with the ones that crop up daily. One benefit of dealing directly and effectively with your emotions is that you will be able to focus better on all aspects of your daily life and participate fully in all of the relationships that are important to you.

And you will be able to stay emotionally present for your child and others who are important in your life.

DON’T FEEL BAD— HERE HAVE A COOKIE, YOU’LL FEEL BETTER

Advising someone who obviously feels bad not to feel that way makes no sense at all. To illustrate, we use the classic story of a child who comes home from preschool with tears in her eyes. Her mom or dad asks, “What happened?”, and the child responds, “The other little girls were mean to me.” To which the parent says, “Don’t Feel Bad, here have a cookie, you’ll feel better.”

In reality, the cookie doesn’t make the child feel better, it makes her feel different. She has merely been distracted from her hurt feelings. And, she has been told by her parents whom she trusts, not to feel bad—even though that makes no sense at all. She has also been taught that when she feels bad she should medicate herself with a substance, in this case, sugar.

Ten years later, we act surprised when after her first romantic break-up, she starts drinking beer or smoking marijuana to push away her hurt

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feelings. Yet, she’s doing exactly what her parents taught her—treating her feelings with substances. Those actions are the result of the well-intended, but misguided, idea of trying to tell someone not to feel bad when they already do.

Another parallel is any attempt to help our mates by trying to shift them from their normal feelings of fear about what might be happening with their child to the intellectual or spiritual ideas that would remove those feelings. Sad, painful, or negative feelings are natural and even serve a purpose. Anything that indicates that we shouldn’t have them is counter-productive and removes some of the safety and trust that partners need to have with each other and with their children.

A better response to the little girl, instead of the offer of cookies, would be, “Ouch, how sad for you to have your feelings hurt. I can remember that happening when I was young, I didn’t feel good either.”

Usually, a parent doesn’t need to say much more than that and the child feels heard and is ready to go out and play.

Sometimes the child will want to talk more about what happened and that’s okay, too. But first you must really hear the hurt feelings, and not try to fix them, just acknowledge them.

BE STRONG OR BE HUMAN – PICK ONE

It’s not uncommon, in the face of a medical diagnosis, for each parent to react differently. Each of us has our own style of communicating [or not] the feelings we are feeling. It is at this point, that a gender-based socialization may play a role.

Summer 2015

There’s a lot of talk about gender and feelings, but we have never been able to correlate happy or sad feelings exclusively to either males or females.

One of the major myths we all learn in childhood, is the incorrect idea that when faced with losses, we must BE STRONG

and/or, BE STRONG FOR OTHERS.

Men, seeing the emotional impact the diagnosis of their child’s condition has on their spouses, will often try to “Be Strong” for their wives. Even though those men are also emotionally affected, they sometimes perceive it as their job to take care of their wives. In so doing, they often push their own emotions about their child’s condition aside, in an attempt to come to the aid of their wives.

When the man hides his emotions in an attempt to be strong for his wife, his nondisplay of emotions will appear to his wife as if he doesn’t care and doesn’t love their child. Nothing could be further from the truth. He cares and loves, but he’s trapped inside the idea that in order to “Be Strong” for his wife, he must not show his feelings.

Compounding the issue is that it’s not uncommon for both parents to try to Be Strong for their child, who then receives very mixed messages, as his parents’ verbal and non-verbal communications don’t match. This is very confusing for the child who’s having his own struggle adapting to the reality of his condition.

We think to be open, honest, and emotional is what strong really looks like.

We’d like to give you a choice: You can Be Strong or you can Be Human, pick one!

FEATURE

LEVERAGE

TM

Th e Ulti m ate Inhibitor A d ventu re

I

ntroducing a revolutionary, new program for young adults with inhibitors.

This 5-day adventure delivers heart-pounding excitement that puts your inner strength to the test!

Find out what you’re made of, and develop new skills that can help you become who you want to be.

If you have always felt restricted by inhibitors and want to prove to yourself that you are beyond your limitations, this is your chance.

Program participation criteria: Participants must have an inhibitor and fall between the ages of 18-32 For more information, go to comphealthed.com, or call (781) 878-8561.

“I got this”

This program is made possible by educational grants provided by: Gold Sponsor: Baxter

Silver Sponsor: NovoNordisk

Coming this Fall - 10.05.2015

Brought to you by:

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FEELINGS AREN’T BROKEN – THEY DON’T NEED TO BE FIXED

Your response would be better if it sounded something like, “Yes, I can hear that you’re scared, and I’m worried also.” Think about the impact of that give and take: No judgment of the other person’s feelings, no attempt to switch the first partner from heart to head, and the creation of a stronger connection by telling your own emotional truth. All of that reinforces trust and safety between the couple at a point when they are really needed.

Your spouse is no different than your child when feelings are the presenting issue. He or she needs to be heard and not fixed, and definitely doesn’t need to be given substances to cover up feelings. So if your mate has a long face and you ask what happened, and they say, “I’m really scared, I think Joey’s having a hard time,” you must NOT respond with “Don’t Feel Bad.”

In an ideal world, a couple using that simple communication skill to help each other get their feelings up and out of their bodies and souls reduces the possibility of an explosion later down the line. As many of you already know, the diagnosis of a condition is only a beginning.

Other problems and complications may arise, which makes it essential that you establish safety for the feelings that will follow.

LISTEN WITH YOUR HEART, NOT YOUR HEAD No matter when the diagnosis hits your family, it’s not too late to start using this new and better idea for debriefing each other on a regular basis. After all, hemophilia is going to remain a central part of your life. The constant stimuli that create emotions in each member of your family are not going to stop. You must become better equipped to deal with the frustration of living with and managing the situation, which includes the never-ending reminder of the original hopes, dreams, and expectations you had for you and your child.

The little girl in the pre-school/ cookie scenario could just as well have been a little boy.

Both genders are subject to the “cookies for feelings” trade off negotiated by adult guardians.

And though we did mention that gender sometimes plays a part in how we behave in a crisis, there are no hard and fast rules as to which partner might be

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“strong” and which one might be “emotional.”

Within many couples, both partners try to give unsolicited opinions and advice—even though none were asked for.

When your mate or child tells you how he or she feels, what they most need and want is to be heard, not fixed.

Our final word on this is, “Listen with your heart not your head.” Be a heart with ears. Do that for each other and your relationship to each other will expand as will your ability to really hear your affected child, as well as any other children you may have.

LISTENING VS. HEARING: A DISTINCTION WITH A DIFFERENCE There’s a world of difference between listening and hearing.

Unfortunately, because we’ve learned to incorrectly separate

happy and sad feelings, and to discourage the expression of the latter, we’ve made a significant portion of our feelings out of bounds. One result of that emotional inequity is that we’ve also learned the bad habit of responding to sad feelings from an intellectual perspective.

On the other hand, we never try to convert other people’s happy feelings into their intellects, only the sad or scary ones.

That makes no sense when someone is trying to tell us about a feeling. You must apply some diligence to develop this new habit of really hearing what is being said.

The comment, “I’m really scared that Joey’s having a hard time,” is a very clear and honest statement of feeling. It is not a call for an opinion or advice.

At the very least, you must acknowledge hearing your mate. If you have a “me too” to add, by all means do so. But never contest or argue with a feeling.

CREATING A “NOADVICE” ZONE In today’s world it’s often true that both parents work in jobs outside the home.

As the divorce rate indicates, this

can add emotional pressure to marital relationships. In families with one or more children with hemophilia, it is not uncommon for one of the parents to be the full-time, hands-on care provider for the children, while the other is out there in the work-day jungle. The at-home job, while different from the one outside the home, is equally pressure packed and exhausting.

As the returning worker needs to debrief his or her day, so does the stayat-home worker, who may have been dealing with emotional forces that expand the boundaries of reason and patience.

Different jobs can never be compared, so it can never be presumed that one set of pressures is worse than another.

Both sides of the communication spectrum must be present for each partner to benefit. Telling the truth about the events and feelings that affected your day is not possible if your partner doesn’t listen or hear effectively.

The obvious solution is that both partners need the opportunity to safely spill out the good, the bad, and the sometimes ugly, that affected their day.

Telling the truth and being heard is the only way to avoid loading up a time bomb that will explode on you when you least expect it.

• • • • • •

PRACTICE, PRACTICE, PRACTICE. Make a pact with yourself not to offer unsolicited opinions or advice. They almost always rob the other person of dignity. Here’s a little trick to help you develop the new habit. If your mate [or child] has told you something, especially about their feelings, and hasn’t asked a question, don’t offer an opinion or give advice.

Practice listening to feelings without offering solutions that weren’t requested.

However, as you listen, you might be bursting to tell them what you think about what they said or how they feel. If so, you can ask this, “I have an opinion about that, would you like to hear it?” If they say “yes,” by gosh, you can tell them what you think. If not, you no longer have an opinion. It’s that simple.

People often tell stories that are wrapped around the feelings they are trying to communicate. The most important parts of those stories are the feelings they contain.

Practice listening to the “heart line” not the storyline.

We know it’s one thing to tell you to do something and another to tell you how to do it. Here are some tips that will help you hear your mate and your children better.

Listen with your heart, not your head. Allow all emotions to be expressed, without judgment, criticism, or analysis.

Recognize that feelings are emotional, not intellectual. Feelings do not need to be understood, just expressed and heard.

Avoid the trap of asking, “What’s wrong?” The automatic response is “Nothing.”

Go first. Instead of asking someone how they feel, tell the truth about your own feelings. That will create safety for the other person to open up.

Be patient. Don’t force others to talk about feelings.

Never say “Don’t feel sad” or “Don’t feel scared.” Sadness and fear, the two most common feelings attached to loss of any kind, are essential to being human.

Who knows? Maybe they’ll hear your heart too.

Russell Friedman is Executive Director of The Grief Recovery Institute Educational Foundation, and co-author of The Grief Recovery Handbook, When Children Grieve, Moving On, Moving Beyond Loss, and The Grief Recovery Handbook for Pet Loss . Please visit the website at: www.griefrecoverymethod. com, which features many articles on Grief Recovery.

FEATURE

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■ Eligible patients can receive up to $12,000 per year in assistance ■ Patients can be eligible for co-pay assistance regardless of income ■ The only available to patients with private insurance CallisBayer’s Factor Solutions: the card co-pay card Callprogram Bayer’s Factor Solutions: PresentPresent the co-pay ■ Assistance is awarded per will patient.

Multiple members of a to household A Case Specialist complete to the pharmacy A Case Specialist will complete the pharmacy when when anfor application your behalf ordering Kogenate FS are assistance they meet the required criteria ordering aneligible application on yourifon behalf Kogenate FS CO-PAY CARD

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and acard co-pay card be Kogenate FS co-pay or co-insurance assistance based on eligibility requirements. The a co-pay will be will *Peopleand with private, commercial health insurance may receive program is on a first-come, first-served basis. Financial support is available for up to 12 months. Eligible patients can re-enroll for additional 12-month mailed mailed to you to you courses. The program is not for patients receiving prescription reimbursement under any federal-, state-, or government-funded insurance programs, or where prohibited by law. All people who meet these criteria are encouraged to apply. Bayer reserves the right to determine eligibility, monitor participation, determine equitable distribution of product, and modify or discontinue the $0 Co-pay Program at any time.

Enrollment is fast and simple. Here’s what you need to do to save: Call Bayer’s Factor Solutions: A Case Specialist will complete an application on your behalf and a co-pay card will be mailed to you

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INDICATIONS ■ Kogenate® FS antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Call Bayer’s Factor Solutions: Call Bayer’s Factor Solutions:

the card co-pay card PresentPresent the co-pay

■ Kogenate FS is used to prevent or control bleeding in adults and children with hemophilia A. A Case Specialist will complete an to the pharmacy A Case Specialist will complete an to the pharmacy when when Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can application yourand behalf ordering Kogenate FS application on youron behalf a and a ordering Kogenate FS reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). co-pay will be to mailed co-pay card willcard be mailed you to you Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.

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Connect with a Factor Solutions Case Specialist today: 1-866-329-3449 Factor Solutions Case Specialists are available from 8:30 am to 5:30 pm (ET), Monday through Friday.

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IMPORTANT SAFETY INFORMATION ■ You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS. ■ Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

■ You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.

■ Your body can make antibodies, called “inhibitors,” against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII. ■ Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

■ Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see brief summary of Kogenate FS Prescribing Information on the following page.

Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2015 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Printed in USA 05/15 PP-575-US-1674

Isn’t Home Infusion the Standard of Care for Hemophilia?

by Barb Forss

O

n April 9th, a terrible decision was made that potentially affects every person who self-infuses clotting factor... a company called Novitas, which is a government oversight agency, determined that a patient who self-infuses NovoSevenRT can no longer do so, unless it is at a Hemophilia Treatment Center under the supervision of a hematologist if you live in the following states, and are a patient on Medicare/Medicaid, the Veterans Administration, or Indian Health Service:

Pennsylvania, New Jersey, Maryland, Delaware, Washington D.C., and parts of Northern Virginia; The Medicare Administrative Contract (MAC) Jurisdiction H (JH), which spans Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, and Mississippi.

Yes, you are reading this correctly; this is actually what’s happening NOW. Amazingly, very little if any information about this has come from the hemophilia community, which is curious.

I was aware that this would become mandated on April 9,

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2015, and began a personal campaign of getting people who use NovoSeven RT, even if they aren’t on Medicare/Medicaid and don’t live in one of the affected states, to write letters to Novitas.

My personal letter follows -

INSURANCE CORNER

Barb’s Letter

“I’m a severe FVII deficient patient who self-infuses NovoSeven RT daily for prophylaxis, and every 3 hours for a bleed, until it’s resolved. I’ve been using this product for over 14 years and it WORKS. I went undiagnosed for 47 years, always being told that I bleed like I have hemophilia, but being a female, I couldn’t possibly have it. I suffered over 26 surgeries (many creating more bleeds), and was given hundreds of units of blood products including FFP, cryoprecipitate, and whole blood, to stem my bleeds. I was hospitalized over 50 times, and tethered to an infusion pole for days and sometimes even weeks. If they threw enough blood products at me, I would eventually stop bleeding, then sometimes start again after being released from the hospital. You can’t imagine how the quality of my life has improved being able to self-infuse my NovoSeven RT and avoid hospitalization from bleeding for the first time in my life.

My understanding is that NovoSeven RT can no longer be self-infused in 12 states by patients who are on Medicare/Medicaid. I don’t live in any of those states, and I’m not on Medicare...yet...but I also run an annual retreat for patients with FVII deficiency, and I know of many patients who are negatively affected by the Novitas decision, and many more who may potentially be.

If this decision were to come down in WA state when I’m on Medicare next year, that would require me to drive 220 miles round-trip, daily, just for my prophy infusion at my Hemophilia Treatment Center in Seattle.

And I suppose I just bring an overnight bag and camp out at my HTC for the duration of any internal bleeds, so that I could be monitored by my hematologist, right?

Please reconsider this determination. Every patient I know who uses NovoSeven RT can self-infuse blindfolded, it’s as easy as pie, and does not require a doctor to be there. I was going to actually video myself doing this blindfolded and send it to you, but decided that would be unprofessional, even if it would make the point. I know at least 500 FVII deficient, FVIII deficient and FIX deficient inhibitor patients, many who will be negatively affected by this decision from Novitas.

The hemophilia community is supposed to be getting better quality care at less cost, according to the Affordable Care Act. This determination by Novitas regarding the use

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of NovoSeven is completely opposite of what ACA was supposed to mean to us. Can you imagine the cost of seeing a physician daily for those who self-infuse?

The cost of travel to their HTC, as well as time? If this decision was made without considering the negative impact on patients, then it needs to be reversed. What happens if this soon takes effect in WA state, and I have a bleed? Do I then need to travel 110 miles to my HTC to be treated? I’ve already suffered one brain bleed, an esophageal bleed, and many gastrointestinal and kidney bleeds over my 63 years and if I had to travel to my HTC to be treated, I would have died. I’m a Patient Advisor and community activist in the hemophilia community, and would very much like to hear what the reasoning is on this decision.

Thank you for your consideration in this life-threatening matter.”

This maps is for illustrative purposes only, and does not guarantee accuracy.

States effected include: Pennsylvania, New Jersey, Maryland, Delaware, Washington D.C., and Northern Virginia; The Medicare Administrative Contract (MAC) Jurisdiction H (JH), which spans Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, and Mississippi.

By nature, I’m not an alarmist, and I’m generally nonconfrontational. By the time you read this, the May 24th deadline to respond to Novitas regarding this decision will have passed. I “blew the whistle” on this decision to the hemophilia community-at-large via social media, as nothing was forthcoming from our community organizations. I know of at least a dozen patients or caregivers of patients who wrote their personal stories, and I encouraged them to do so. Stories of negative impact on patients DO make a difference! We will keep you posted as to what decision is made by Novitas regarding rescinding this ruling. We’ve come so far, and been encouraged to be independent of our HTCs and use them mostly for consultation. Are we going backwards? What’s happening in this community, and why? Nobody seems to be able to answer that for me...for now...stay tuned!

Barbara Forss Executive Director/Founder www.LadyBugsFoundation.org

For more information, please visit LA Kelley Communications, Inc.: http://blog.kelleycom. com/2015/05/one-giant-leapbackward-for-treatment.html

INSURANCE CORNER

THE FIRST AND ONLY FACTOR VIII WITH A PROLONGED HALF-LIFE Learn how a prolonged half-life may affect your infusion schedule

Meet your CoRe Manager Nikita Lyons Murry E: Nikita.LyonsMurry@biogenidec.com T: 615-525-1003 This information is not intended to replace discussions with your healthcare provider.

Indications ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.

Important Safety Information Do not use ELOCTATE if you have had an allergic reaction to it in the past.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII. Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly.

Common side effects of ELOCTATE are joint pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Brief Summary of full Prescribing Information on the next page.

© 2015 Biogen Idec Inc. All rights reserved. Printed in U.S.A. HFE-1006322-02 11/14

FDA-Approved Patient Labeling Patient Information ELOCTATE™ /el’ ok’ tate/ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Please read this Patient Information carefully before using ELOCTATE and each time you get a refill, as there may be new information.

This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ELOCTATE? ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ELOCTATE when you have surgery.

Who should not use ELOCTATE? You should not use ELOCTATE if you had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ELOCTATE? Talk to your healthcare provider about: • Any medical problems that you have or had.

• All prescription and non-prescription medicines that you take, including over-the-counter medicines, supplements or herbal medicines.

• Pregnancy or if you are planning to become pregnant. It is not known if ELOCTATE may harm your unborn baby.

• Breastfeeding. It is not known if ELOCTATE passes into the milk and if it can harm your baby.

How should I use ELOCTATE? You get ELOCTATE as an infusion into your vein. Your healthcare provider will instruct you on how to do infusions on your own, and may watch you give yourself the first dose of ELOCTATE. Contact your healthcare provider right away if bleeding is not controlled after using ELOCTATE. What are the possible side effects of ELOCTATE? Common side effects of ELOCTATE are joint pain and general discomfort.

Allergic reactions may occur. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

How should I store ELOCTATE? • Keep ELOCTATE in its original package.

• Protect it from light.

• Do not freeze.

• Store refrigerated (2°C to 8°C or 36°F to 46°F) or at room temperature [not to exceed 30°C (86°F)], for up to six months.

• When storing at room temperature: • Note on the carton the date on which the product is removed from refrigeration.

• Use the product before the end of this 6 month period or discard it.

• Do not return the product to the refrigerator.

Do not use ELOCTATE after the expiration date printed on the vial or, if you removed it from the refrigerator, after the date that was noted on the carton, whichever is earlier.

After reconstitution (mixing with the diluent): • Do not use ELOCTATE if the reconstituted solution is not clear to slightly opalescent and colorless.

• Use reconstituted product as soon as possible • You may store reconstituted solution at room temperature, not to exceed 30°C (86°F), for up to three hours. Protect the reconstituted product from direct sunlight. Discard any product not used within three hours.

What else should I know about ELOCTATE? Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.

Manufactured by: Biogen Idec Inc. 14 Cambridge Center, Cambridge, MA 02142 USA U.S. License # 1697 44279-01 ELOCTATE™ is a trademark of Biogen Idec.

Issued June 2014

Everybody Gets to Have a Bad Day Once in Awhile

by Dr. Gary McClain, PhD

O

ur family members can certainly be a joy. Except when they’re not. In the right place at the right moment, even someone you love can seem like a pretty bad person, like when a family member: •

Accuses you of not holding up your end on the household chores, when you’re doing the best you can Tells you to “just think positive” when you try to talk about the challenges you’re dealing with Criticizes you for neglecting some aspect of taking care of a family member – or yourself – without understanding what really happened Just plain ignores you

• •

•

When one member of the family is living with a chronic condition, everybody in the house is living with it because everybody is affected. And dealing with the challenges of a chronic condition can put your emotions on edge. Especially those days when you don’t feel so well, or when you’ve had yet another problem to solve, or when you feel like you’re spinning your wheels and not getting anywhere.

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FAMILY MATTERS

When you’re feeling on edge, a supportive family member can make a positive difference in your life by giving you the encouragement you need to have a better day. A smile, a few caring words, an offer to give you a helping hand… Who doesn’t feel better when a little love is tossed in their direction? And after all, isn’t that what you do for everyone else?

On the other hand… some days, family members aren’t able or willing to provide that encouragement and, instead, say something angry, or hurtful, or just not seem to care at all.

“

Wow! I thought you loved me! What happened?

”

So if you are having one of those dark cloud days – and so is your family member – your cloudy day and their cloudy day on the same day equals the perfect storm.

And when the storm hits, all you can see is what’s in front of you.

Something relatively small – like the actions of a family member – may suddenly look very large. So large that, in fact, not only are their actions magnified, but so is the impact of these actions on your day. Those words of impatience may feel like the harshest thing they could ever say to you. Or, not noticing that you need some help may feel like the ultimate rejection. How could you possibly be this way!!!

What’s important to consider is that turning your loved one into a bad guy doesn’t make you feel any better, or at least not for long. It just gives you a target for your frustration. Along with an excuse to let your feelings bubble up and boil over, and shove reason and rational thinking off into the corner. You end up feeling that all of that negativity is justified. That means more suffering, and stress, for everybody in the house!

Making a family member the bad guy can drive a wedge between the two of you. You risk damaging a relationship with someone who plays an important role in your life!

So… when you’re having one of those days when your reactions to other people are a little over the top, here are some ideas to consider:

Take a step back and look at the situation objectively Yes, our loved ones do things that disappoint us or make us mad. But the frustration or anger or disappointment that you are feeling may be part of something much bigger, something going on with you. The people who are closest to us can also be the closest target for our frustration. Is it your family member, or is something else bothering you?

Try to identify what button is being pushed When someone isn’t very helpful, or is unkind, we can be reminded of all the other times in our life when people weren’t very helpful, or treated us poorly, or bullied us. And feel that pain again. And when we are feeling this way, old resentments that we feel toward a loved one – resentment that we thought we had left in the past – can suddenly bubble up. Yes, it’s about that person, but it might also be about a lot of other people in your past. Do you see the pattern? Is there something that the two of you need to talk about and resolve? Or is it something that you need to do some more work on letting go of?

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Stand back and get a wider view Your family member’s current behavior may stick out like a sore thumb, but isn’t there more to the relationship than this moment in time? What do you most value about your relationship? What do you most admire about them?

Recall a time when your family member was there when you needed them. Or a fun time that you enjoyed together. Or the loving manner in which they treated you yesterday. In other words, look at the big picture.

Consider the possibility that someone else is also having a bad day It’s only human to have expectations for the people in our lives who are closest to us. But let’s face it; people don’t always meet

our expectations. Your loved one may have something going on that they aren’t ready to share, or don’t know how to share. Is there anything you can do to make their day better?

Keep in mind that time doesn’t always heal all wounds When someone close to you disappoints or angers you, it is easy to react by cutting them off. But when we stop communicating with someone, our minds have a way of rewriting the story, making the wound that much deeper, and turning a misdemeanor into a major crime. How about getting the communication going again, maybe starting out with making a kind gesture of your own, or offering to talk things out. Don’t let a tiff turn into a tragedy.

Do what you can to keep the communication going Accept what you can’t do. Some family members may be unable or unwilling to be supportive, or at least as supportive as we need them to be. Expand your social network by bringing more supportive and caring people into your life.

Let’s give everybody in the house some breathing space, starting with allowing each other to be human. After all, we are all in this together!

Gary McClain, PhD, LMHC, is a therapist, patient advocate, and author, specializing in helping clients deal with the emotional impact of chronic and life-threatening illnesses, as well as their families and professional caregivers. He works with them to understand and cope with their emotions, to learn about their lifestyle and treatment options, to maintain compliance with medical regimens, to communicate effectively with the medical establishment, and to listen to their own inner voice as they make decisions about the future. His email is: gary@JustGotDiagnosed.com. He welcomes your questions and comments.

FAMILY MATTERS

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Novel Treatment Shows

T

Great Promise

Towards Long-Lasting Solutions

reatment development for hemophilia patients has been steadily progressing with the advent of longer lasting, more precise factors. Although current treatments of clotting concentrates have vastly improved quality of life for those affected by the disorder, some view the treatments as expensive and inconvenient. Patients may therefore wonder if there has been as much progression on finding longer term solutions, and ultimately a cure.

Thankfully there is one study which shows great promise. Published in 2011 in the New England Journal of Medicine, Dr. Nathwani and his research team used gene therapy in six Hemophilia B patients in an effort to reduce or eliminate the need for infusions. His team used a custommade ‘virus’ to deliver genetic material to the patients’ liver cells, where the factor for the body is manufactured.

It should be noted that while Hemophilia is an X-linked disorder, the genetic information delivered is highly specific, and was targeted to Chromosome 16; therefore any treatment would not be passed down to offspring. Once delivered, the genetic material would attach to the chromosome and assist the patient’s own cellular machinery to manufacture working factor. As an added bonus, upon incorporation the affected cell would continue to manufacture the new-found FIX, therefore greatly reducing the need for continuous periodic infusions. This would be more convenient for the patients, as well as greatly reduce cost of the treatment.

Group 1 The treatment results were very successful.

While all the men started with <1% normal levels of factor at the beginning, all six recipients increased to at least 1% in 2-4 weeks of administration. The first two patients, designated as the Low-Dose group, received the smallest dose of the virus and saw their levels increase to 1-2% within four weeks. They enjoyed these levels for over eight months after the injection.

Group 2 The next two patients, designated as the Intermediate-Dose group, received three times the amount of dosage as the Low-Dose group.

They saw their functional levels rise to 2-3% and also saw these results last again for about eight months. One of these two patients was able to participate in heavy physical activity, such as soccer, with no instances of spontaneous hemorrhage.

Group 3 The final two patients were designated the

High-Dose group. They received three times the dosage as the Intermediate-Dose group, and saw significant rise in their functional factor levels. Patient 5 saw his levels rise to 5-7% within two weeks of treatment which continued for two months. He did begin to see an extremely small immunological reaction; however, these never reached near adverse levels and were quickly and safely handled. The participant then enjoyed 3% levels for over six more months.

The final patient saw dramatic increase and stabilized to 8-12% within eight weeks which lasted several months. He too saw very minute immunological activity, however it is believed that this could have been due to his now very extraneous physical activity (such as training for and running a marathon). His reaction was also quickly and easily handled.

Four of the six patients, the Intermediate and High Dose groups, were able to discontinue FIX infusions outright, with no cases of spontaneous hemorrhage. The other two in the Low-Dose group had greatly increased their time between infusions to about two weeks. The results are quite substantial as all six patients needed

by Vladimir M. Zoubine

infusions multiple times (2-3) per week before treatment. Infusions were needed for special cases for some patients (such as dramatic injury or surgery). It should be reminded that this was a single, peripheral injection, which had such dynamic and lasting results. The HighDose group did see a very small immunological response, however this was not a large enough reaction to elicit any symptoms or concern and those patients were given small cautionary treatment of those reactions which were successful in eliminating any concern over the safety of this custom made virus’ administration.

In conclusion, Dr. Nathwani and his team have shown that gene therapy for the treatment of Hemophilia B has been successful, and provides great support that further research will develop even better treatments as well as treatments for other hemophilia variant patients.

There may be some concerns from patients over the idea of genetically modifying the human genome in a living person, however due to the fact that hemophilia is indeed a genetic disorder, any true cure must therefore correct the problem at its’ source. Dr. Nathwani’s research, as well as decades of previous virus vector research should reassure patients that these treatments are highly specific, rigorously tested, and continuously revisited for ethics and safety, and efficacy.

This study is so important for hemophilia patients and their families because this treatment has been shown as convenient, less expensive, with little to no safety risks, and most importantly: effective. This treatment method may soon be more effective than longlasting protein factors, and could become the default method for treating this disorder. More research is always needed, but so far the results have been positively enlightening both for researchers and patients alike.

Summary of: Nathwani, Amit C. et al. “Adenovirus-Associated Virus Vector–Mediated Gene Transfer in Hemophilia B.” The New England Journal of Medicine 365.25 (2011): 2357–2365. PMC. Web. 19 Apr. 2015.

Summary Authorship: Vladimir M. Zoubine, B.S. Biology University of Massachusetts-Boston

BLOODLINES

Alphanate® More is Less

Now Alphanate users can infuse more units in less volume! The FVIII/VWF complex

(manufactured by Grifols) now has FDA-approved vials available in 2,000 IUs. They

are reconstituted with 10ml of diluent, and are a 500 IU increase from their highest assay previously available. So more IUs per vial means less time spent infusing!

It should be noted that Alphanate is commonly prescribed for individuals with inhibitors who are undergoing ITT (Immune Tolerance Therapy). But Alphanate is only FDA approved for the following uses: • • Photo courtesy of Grifols

Control and prevention of bleeding in patients with hemophilia A Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP®) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (type 3) undergoing major surgery

What Happened to SevenSECURE®!?

Novo Nordisk is launching a new, comprehensive patient

support program specifically designed for and inspired by the bleeding disorders community—

NovoSecure™. The program is replacing SevenSECURE , which has been an ®

integral part of the company’s offering for several years.

patients with Hemophilia A, Hemophilia A or B with inhibitors, Factor VII Deficiency, Acquired Hemophilia, Glanzmann’s

Thrombasthenia, or Factor XIII Deficiency, regardless of product choice. NovoSecure™ enrollees can apply for a variety of programs, including: •

Competitive scholarships

•

Career counseling

•

NovoSecure™ reflects the

bleeding disorders community’s

evolving needs and aims to better help all enrollees reach their

personal goals. The program

launched on March 26,

2015, and is open to

•

Life coaching with HeroPath™ Insurance support

In addition, Novo Nordisk offers Product & Co-pay Assistance

Programs for eligible patients who have been prescribed Novo Nordisk products.

Current SevenSECURE® members will be automatically

enrolled in the NovoSecure™ program. They will also be able to

access their existing SevenSECURE® medical expense and educational grant benefits by visiting SevenSECURE.com through December 1, 2015.

To learn more, call

1-844-NOVOSEC (1-844-668-6732)

or visit mynovosecure.com.

Source: NovoNordisk

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BLOODLINES

QUALITY WHERE IT COUNTS IN 25 YEARS, we’ve developed a reputation. To families, we’re a team who offers the highest-quality care. And to bleeding disorders organizations, we’re a supporter whose commitment and contributions have never stopped.

We’re not here to boast. We’re here to promise: Another 25 years of good care—and good character.

CALL 800.243.4621 | EMAIL

| VISIT

AHF Hemophilia Services Living with an Inhibitor can be complicated + difficult.

Let AHF give you a few extra hands.

10: Top

10. On a first date

Result: No second date

9. In the shower

Copyright © 2014 by American Homecare Federation Inc. All rights reserved.

Diplomat and American Homecare Federation are either registered trademarks or trademarks of Diplomat Pharmacy Inc. 002802-1114

Advised Times & Places to Self-Infuse

Result: Leaving this one to the imagination..

8. During a routine traffic stop with N.W.A. blaring on the radio

Result: 90 days of community service and a black eye from police brutality

7. In a moving vehicle, if you or a cabdriver are behind the wheel Result: “Swiss cheese” arm

6. On a roller coaster with loops

Result: “Swiss cheese” arm for your riding buddy

5. At the ER

Result: Longer hospitalizations, or near-death experience – Infuse before you go!

4. In public restrooms with empty soap dispensers Result: Amputation by flesh-eating bacteria

3. Outside of a rehab center Result: 6 months of rehab

2. Inside of a rehab center

Result: Getting mauled by nearby strangers

1. In a TSA line

Result: Your name on the “no fly” list and a 6 hour meet and greet with Norm, the interrogator

by Eric Lowe

For entertainment purposes only. See full disclaimer on page 3.

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FUN & INSPIRATION

504 orMaking IEPSense of It - All! T

by Janet Brewer, M.Ed

here are two federally mandated plans that all school age students are entitled to. States also are mandated to provide special education services or related services and accommodations to children with a diagnosed disability.

IDEA-Individuals with Disabilities Education Act1974 Amended 2004 IDEA requires states to provide a “free appropriate public education” to children with disabilities so they can be educated to the fullest extent possible with other children. If qualified, children are provided with special education AND related services under an Individualized Education Plan.

Disabilities Include: •

Physical, sensory, mental or emotional

•

Orthopedic Impairment

• • • • • • • •

Emotional Disturbance

Section 504 of the Rehabilitation Act of 1973

This Act’s focus is on non-discrimination. It maintains “no otherwise qualified individual with a disability will be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance”.

American with Disabilities Act 1990

ADA is almost like an extension of Section 504. It provides for the elimination of barriers related to accessibility for the disabled to buildings, transportation, and communication.

Traumatic Brain Injury

Both 504 and ADA provide related services and accommodations to qualified individuals with a disability through a 504 plan. Its intent is to provide access or remove barriers to participation. It provides students with the same rights and services as their “NON Disabled Peers”.

Intellectual Disability

How a Bleeding Disorder Fits In:

Hearing-Vision Impairment Autism

Other Health Impairment Specific Learning Disability

IDEA-Other Health Impairment

Multiple Disabilities

IDEA defines Other Health Impairments as due to chronic or acute health problems such as asthma, attention deficit disorder, crohn’s or hemophilia and adversely affects a child’s educational performance.

ADA/504-Medically Related Disability

ADA/504 defines a Medically Related Disability as a physical or mental impairment that substantially limits one or more major life activities or those basic activities that the average person in the general population can perform with little or no difficulty.

The individual has a record of such impairment and is regarded as having such impairment.

If your child is diagnosed with any of the above disabilities AND they require specialized instruction-they qualify for an Individualized Education Plan.

Specialized instruction is defined as adapted instruction designed to meet the unique need of the child with a disability.

The content, methodology or delivery of instruction is changed to ensure the child’s access to the general curriculum.

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To find more information on 504s, IEPs, accommodations and working with your child’s school, you may access more of Janet’s work through HFA’s School Toolkit at: http://www.hemophiliafed.org/resource-library/settingthe-stage-for-school-success-august-2011-webinar

How Does My Child Qualify?

If there are no academic, behavior or emotional concerns:

Make an appointment with your building principal/ADA coordinator, teacher (s), and school nurse and ask to develop a 504/ADA plan.

If there are academic, behavior or emotional concerns:

Write a letter to your child’s teacher asking for a formal evaluation process stating your concerns and submit it to the school. The school has an obligation to complete all assessments in the areas of suspected disability (ies) within 60 calendar days.

When assessments are complete:

1. A meeting will be scheduled

2. Reports will be shared with you regarding your child’s abilities

3. The Student Assist Team will then decide if your child: a. Has a disability b. Requires specialized instruction in order to make process

Remember:

Disability + Specialized Instruction = Individualized Education Plan Disability + Related Services/Accommodations = ADA/504

What are Related Services?

Related services may include: • • • • • • • •

Speech/language therapy Audiology (hearing loss) Psychological Physical/Occupational therapies Counseling Rehabilitative counseling School health services Transportation

For example:

If you are comfortable with your school district’s physical therapist then PT could be included on your child’s ADA/504 plan and they could receive physical therapy during the school day. Providing the therapist with additional information on physical therapy with an individual with hemophilia will probably be necessary, as well as contact information from the ordering physician to be sure the therapist proceeds slowly.

What Accommodations Can Be Provided?

Reasonable accommodations are provided to remove barriers related to access. For example: If your child is on crutches, ambulating safely in

the hallway is a barrier. Allowing extended travel time around the building removes that barrier. An extra set of books to prevent a heavy backpack and subsequent shoulder bleeds. A locker that is accessible from a wheelchair at the end of the row is more accessible.

Maintaining open and honest communication with your school district enables your child to be more successful. Stating your needs in a detailed, positive manner yields better results. Most school districts are very responsive, but they are working with tight budgets and are often understaffed. Letting them know that you appreciate their efforts on behalf of your child goes a long way. Also remember, there may come a time that your child may not want these accommodations such as leaving early from class while on crutches or a wheelchair as it calls unwanted, sometimes intrusive attention. More than anything, our children just want to fit it. Let them make those decisions. Their social interactions with peers are just as important, if not more important than leaving class early. Or, there are times that it is ok to “play the hemophilia card” and invite a special friend or attractive classmate to push their wheelchair or carry their books!

Sources: Federal Regulations Part 300

WHAT’S the PLAN?

89 E. Washington Street Hanson, MA 02341-1125

CHES Mission To Inspire awareness and selfreliance for patients with chronic health conditions, their families, and their communities.

Editors in Chief Janet Brewer, M. Ed. Eric Lowe

Publication Designer Eric Lowe

Contributing Writers: Janet Brewer, M.Ed Eric Lowe Tom Sitzler Farah & Porus Parvi Harpreet Maan Russell Friedman Barb Forss Dr. Gary McClain, PhD Vladimir Zoubine

Contributing Editor: Stephen Brewer

Contributing Content and Production: Joan Ward

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