Lifelines for Health (vol 8): How to Thrive in Today's World and Manage Your Anger by CHES

A CHES Publication

How to

Fall 2016 I Volume 8

hrive

World IN Manage

Today’s YOUR

Inhibitor Family Camp MANIA! l Opening New Doors of HOPE: a Review of NHF’s 2016 Inhibitor Summit l How to Approach a 504, IEP Meeting l Felt Angry Lately? l PROS & CONS: Learning Self-Infusion l My Life, Our Future: A Valuable Opportunity Coming to an End l Meet the Matrix Health Group

Integrity, Accuracy, Empathy...

FEATURE 18 I How to Thrive in Today’s World and Manage Your Anger When living with any chronic health condition, such as inhibitors, anger is an inevitable part of life. Licensed, independent clinical social worker, Matt Manela takes us through his twelve steps to managing anger. His steps face the essential dealings of anger head-on from recognition and understanding to acceptance, and finally, execution.

CONTENTS COMMUNITY CHATTER

FAMILY MATTERS

6 I Inhibitor Family Camp MANIA!

32 I Felt Angry Lately?

Inhibitor Family Camp (IFC) received global recognition this year, as CHES had the privilege of displaying an abstract poster outlining IFC and its success at the World Federation of Hemophilia’s (WFH) Congress. IFC was also cited in WFH’s Haemophilia journal.

Anger is a natural emotion. Don’t suppress it or will it away. Instead, embrace it and take control as Dr. Gary McClain offers his advice in helping yourself, as well as others.

9 I Opening New Doors of HOPE: a Review of NHF’s 2016 Inhibitor Summit

36 I My Life, Our Future: A Valuable Opportunity Coming to an End

Marianna Grieco (mother of a child with inhibitors) takes us to NHF’s 2016 Inhibitor Summit in New Orleans. She shares with us some of the key developments that bring us new hope.

FUN & INSPIRATION 10 I PROS & CONS: Learning SelfInfusion In patient advocacy, the skill of phlebotomy is one of the biggest milestones we or our children can reach. Let’s celebrate this achievement with a little laughter. (For entertainment purposes only.)

WHAT’S NEW 30 I Choices, Choices: What to Do... There are nearly 30 factor products on the market today. But you don’t have to be a pharmacist to keep an inventory of them all. A friend gave us a cheat sheet, and now we’re going to share it with you.

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BLOODLINES What is My Life, Our Future? In a nutshell, a research project for the bleeding disorders community to genotype our blood for future improvements in research and treatment. But to fully benefit from it, you must participate- quickly!

WHAT’S the PLAN? 42 I How to Approach a 504, IEP Meeting (or any other meeting at your child’s school) Advocating for your child at a school meeting can be a bit overwhelming to say the least. Take school psychologist, Lisa Cosseboom’s advice to acquire your child’s needs without blowing your lid.

SPOTLIGHT 44 I Meet the Matrix Health Group: Dedicated to Making a Difference... This fall, we added a new addition to Lifelines called Spotlight to learn more about the very people who are part of our support system. Justin Lindhorst, specialty care coordinator at Matrix explains.

CONTENTS

Did YOU Know? In 2017, CHES will be presenting one new program for the inhibitor population, resurrecting another, and continuing two others for a total of four inhibitor programs!

(1) The newest, After the Shock, is scheduled in June for families of children with an inhibitor ages 0-6 at Camp Zeke in Lakewood, PA.

(2) Momentum debuted in the early spring of 2015 for men with inhibitors ages 18 and up. CHES is bringing back this popular, 3-day session in 2017 in San Francisco, CA.

(3) For its 8th consecutive year, Inhibitor Family Camp (IFC) is returning for families with children living with inhibitors ages 6-18. IFC is set to run Friday, Feb. 17th-20th at Victory Junction, and again on Friday, Oct. 6th-9th at The Painted Turtle.

(4) Lastly, Leverage is an adventurebased camp for individuals with inhibitors ages 18 and up. It’s scheduled for Wednesday, May 17th21st in Portland, OR. More info on all of our programs is available on 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 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.

Letter From the Editors As a former teacher, autumn was always the time for new experiences and beginnings. An energetic group of inquisitive young minds to educate, empower, and learn from! Here at CHES, we continue to learn from YOU, our program participants and families about what you want to learn to be informed, educated, and empowered advocates for your child’s or your own healthcare needs. In 2017, we are preparing to offer four (4) programs for the inhibitor community. Our programs are meant to augment the resources currently available in this community. We are also thrilled to launch Ladybugs, a program for women ages 16+ that live with or care for an individual(s) with a bleeding disorder, with the goal of a national women’s summit in summer 2017 (stay tuned). All of our programs are supported by competitive, educational grants from manufacturers that provide the opportunity to offer educational programs free of charge to families. We are an independent, educational, privately owned company run by two members of the hemophilia with an inhibitor community who care passionately about our families. As we often say, “we don’t just know inhibitors, with live them.” As families or individuals living with a chronic health condition, anger is an emotion that is consistently expressed, sometimes loudly with collateral damage. It is often confused with disappointment, sadness, and frustration. Wrap pain around these emotions and suddenly our homes are a powder keg. Or, you may have the opposite scenario where anger and disappointment gets turned inward resulting in behaviors such as seclusion, anxiety or isolation. Sound familiar? These feelings affect every member in the family unit and each person acts them out in their own way. Are you the caregiver? Then you are managing everyone’s emotions and frequently overlooking your own. In our feature article we asked Matt Manela to share his 12 steps of anger. As a teacher, I loved how Mercer Mayer’s Little Critter series broke down normal human feelings and reactions at the level a child could understand. One of my children’s favorite bedtimes stories was So Mad by Mercer Mayer. In a home with three children, never mind a chronic condition, there was always someone who was soooooo mad! Anger is a very natural emotion, yet it is often the one we have the most difficulty expressing or responding to. In some situations, it is an emotion we fear. In Family Matters, Dr. McClain offers strategies to manage one’s own anger as well as the anger of others. Used wisely, anger can be a valuable emotion as it propels us to make a change. As individuals and families managing a rare, chronic, life-threatening disorder, we operate in a state of hyper vigilance. Always ready to go to battle-dressed and ready! In What’s the Plan, we suggest a scenario where you leave your battle dress at the door. It does not serve a functional purpose when negotiating a team approach for your child’s educational needs. Our Fun and Inspiration section continues to offers the mandatory humorous side of managing the daily challenges we face. It is ok to cry (and often necessary), but if you can, you may as well laugh! Community Chatter brings news of events and programs specific to the inhibitor community written by community members. We look forward to our writer’s perspective in every edition. How much do you know about the My Life Our Future study that began in 2013? MLOF serves to further expand our knowledge about hemophilia genotypes and treatment. Its’ discoveries have caused the study to broaden its scope into 2017 to include potential (unconfirmed) carriers, that must have a first, second or third degree relative with a confirmed hemophilia A or B diagnosis. Read more about MLOF in Bloodlines. Did you know there are currently 28 factor products in the market place for the treatment of Hemophilia A and B to include bypassing products for inhibitors? In our What’s New segment, we share the latest factor chart organized by LA Kelley CommunicationsTM as a visual to keep track of the myriad of new factor products and manufacturers. As we move into 2017 with Donald J. Trump as our President Elect, take a step back, breathe and hold on for the ride. Effect change where you can as only you control your own emotions and destiny. Choose to be an advocate! Do you have an idea, comment or suggestion? We really want to hear from you! - Janet Brewer & Eric Lowe “If we’re growing, we are always going to be out of our comfort zone” -John Maxwell jbrewer@comphealthed.com l elowe@comphealthed.com

Innovative CHES Programs

About CHES Comprehensive Health Education Services has been serving the needs of those with rare bleeding conditions since 2009. As long time members of the bleeding disorder community, our mission is to inspire awareness and self-reliance for patients with chronic health conditions, their families, and their communities. The descriptions below give a brief overview of the various programs we currently offer. For more information on our programs, visit comphealthed.com.

Lifelines for HealthSM is the only national publication specifically created for the inhibitor community. It is distributed biannually to over 200 families living with inhibitors and over 550 HTC’s, local chapters, and industry members.

This brand new program provides parents and caregivers of newly diagnosed children (ages 0-6) with hemophilia and inhibitors the extra support they may need.

Inhibitor Family CampTM was created to give children (ages 6-18) with inhibitors the same annual camp opportunities and experiences as their peers in the bleeding disorders community. These weekend programs are open to the entire, immediate family, and packed full of education, support and – most of all – fun designed specifically for children with active inhibitors and their families. We play, learn, and grow while we build stronger relationships.

CHES understands at a personal level the obstacles and challenges that coincide with raising a child with inhibitors. We strive to equip every new parent with additional tools to navigate his/her child through everything from hospital stays to home infusion.

Leverage is a pioneering, national program for young adults from ages 18 and up that have hemophilia with an inhibitor. TM

Individuals with Glanzmann’s Thrombasthenia (GT) are 1 in a million and this symposium is intended to bring those affected by this very rare bleeding disorder together to establish a community. The GT Symposia is available to anyone with GT and their entire, immediate family.

The program consists of life changing experiences that allow participants to challenge themselves in ways they never thought possible through a series of outdoor adventure experiential education activities, including fishing, rafting, reflection, and various ropes courses.

The LadyBugsTM program empowers women ages 16+ that are affected by, care for someone, or carry a bleeding disorder. The program’s goal is to assist women to find their voice when it comes to decision making about the health of themselves and their loved ones.

With an incidence of 1:500,000, very few resources exist to educate those who live with FVII deficiency. CHES and the LadyBugs Foundation (now a CHES LadyBugs program) teamed up in 2012 to present the only national program of its’ kind for those affected by FVII. This multiday program is open to anyone with FVII deficiency along with their entire, immediate family. The CHESTM logo and program logos are registered trademarks of Comprehensive Health Education Services, LLC. The use of these marks are restricted in part or their entirety without expressed written consent.

Inhibitor Family Camp

CHES Displays at the World Federation of Hemophilia

uly 2016 launched a series of firsts when the World Federation of Hemophilia Congress was held in Orlando, FL following the 68th Annual National Hemophilia Foundation’s meeting. The XXXII International Congress was predicted to be the largest in the WFH’s history, with more than 6,000 anticipated attendees from over 125 countries. This marked the first time that the United States has hosted the WFH Congress in over twenty-five years. It also marked the first time that Eric and I have ever had the opportunity to attend a World Congress as members of the bleeding disorder community. It was a profound and humbling learning experience as we witnessed just how extraordinarily lucky we are here in the U.S.

Poster Abstract

Another exciting moment in 2016 was when CHES presented a quality of life poster abstract for Inhibitor Family Camp (IFC) for the first time. We are honored to report that from 2010-2015 and 10 sessions of IFC, this program has an overall satisfaction rating of 94%. We have served almost 100 families and nearly 200

LIFELINES for HEALTH

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by Janet Brewer, M.Ed.

patients during our family camps. IFC has been sponsored by CHES and supported by an educational grant from Novo Nordisk since 2010. In 6 short years, it grew from a 2 night-once a year program, to a 3-night-twice per year program! The Family Camps began as an opportunity for families to continue the connections made at the Inhibitor Summits in an intimate setting. Its founders, Janet Brewer, Eric Lowe and Jane Cavanaugh Smith recognized its importance from the personal perspective as mothers and individuals who knew that the inhibitor community needed “a camp to call their own”. The majority of our surveyed participants indicated that IFC is THE annual hemophilia camp experience for their child. We share our participant’s sentiments on the following about how important this program is to their families. CHES is proud to serve the needs of the inhibitor community through our programs such as Inhibitor Family Camp now entering it’s 7th year. We look forward to sharing this experience with new and seasoned IFC families!

N A! AN IA MA “This is OUR camp!!"

“After a weekend with other families at camp you leave feeling whole.”

“The children were able to spend more time away from parents and make connections with other children.”

“People here understand us. They “get” how difficult inhibitors can be. People with “just” hemophilia rarely relate.”

CHES in Haemophilia

by Janet Brewer, M.Ed.

Official Journal of the World Federation of Hemophilia

omprehensive Health Education Services was cited in the July 2016 edition of Haemophilia for sponsoring the only national camp program for children and families affected by an active inhibitor. Inhibitor Family Camp was created as a result of feedback from participants brought together by the Inhibitor Summits sponsored by NHF and supported by an educational grant from Novo Nordisk. These families were desperately seeking more opportunities to build stronger relationships in an intimate setting. Camp was the best setting we knew to foster those feelings of community, support, leadership, and autonomy. The majority of our families indicate that IFC will be their child’s only annual camp experience.

Improving comprehensive care in the haemophilia community: building on the HERO Study

A. BUZZI,* L. KELLEY,† M. GREGORY,‡ M. SKINNER§ and W. KALNINS¶ *Fondazione Paracelso, Milan, Italy; †LA Kelley Communications, Inc., Georgetown, MA, USA; ‡UK Haemophilia Society, London, UK; §World Federation of Hemophilia, Washington, DC, USA; and ¶German Haemophilia Society, Hamburg,Germany IFC is supported by an educational grant from Novo Nordisk. We are deeply grateful for their support to this program. In addition, we would like to thank Jane Cavanaugh-Smith for her pivotal role for the inception of Inhibitor Family Camp. Inhibitor Family Camp-because everyone deserves a camp to call their own. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

COMMUNITY CHATTER

an Innovative CHES Program

About the Program 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 6-18. 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. New families have first priority. To learn more or register visit: InhibitorFamilyCamp.org, or call 781.878.8561

Program Update! This fall’s session was coincidentally scheduled the same weekend that Hurricane Matthew hit the Eastern Seaboard, so sadly, we had to postpone our trip to Victory Junction. If October 7th-10th wasn’t conducive to your schedule, CHES is hopeful that the new date will be. NEW DATE: President’s Day Weekend Friday, Feb. 17th - Monday, the 20th, 2017 Location: Victory Junction, located in Randleman, NC Registration: Closes Wednesday, Feb. 8th, 2017 Presented by

Supported by an educational grant from

2017 FALL SESSION

See It to Experience It! Check out our video at InhibitorFamilyCamp.org to understand what camp is really all about.

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Date: Friday, Oct. 6th - Monday, Oct. 9th, 2017 Location: The Painted Turtle in Lake Hughes, CA Registration Opens: Friday, June 2nd, 2017

Opening New Doors of

HOPE

a Review of NHF’s 2016 Inhibitor Summit

lex was only 7 months old when we discovered that he had severe hemophilia A.

“Hemophilia” was just an unknown word for us until we started to research and learn everything possible about this rare condition, complications, and treatments. We didn’t know what to expect. How would his and our family’s future look? When we discovered that our baby had a rare condition, we were overwhelmed with a million emotions. We felt alone and hopeless until we found the hemophilia community - our big family. “Inhibitor” was the second unknown word that we learned soon after. Inhibitors can develop in up to 35% of people with hemophilia A who receive factor VIII replacement therapy. Alex was unfortunately in this percentage. We started once a week prophylaxis when Alex was 18 months old and he developed inhibitors only after 17 treatments. For those with hemophilia there is factor replacement. For people with inhibitors there is only hope. Hope that the immune tolerance works and you can manage hemophilia once again with factor replacement. In 2013, we were encouraged to attend the Inhibitor Summit in Seattle for the first time. Since then we try to attend every year. Attending the educational sessions with highly qualified experts at the Inhibitor Summit is a wonderful way to enrich our knowledge about hemophilia. We also meet other families that understand our feelings and our fears as we laugh, cry, and support each other. This year the Inhibitor Summit was in beautiful New Orleans. We attended at a new and very interesting time. We learned more about new upcoming treatments like ACE910, ALN-AT3, and gene therapy. It was amazing to see the excitement around the new treatments not only from the inhibitor community but also from the medical staff.

By Marianna Grieco

We learned how an ultrasound scan can be used to evaluate joint damage and joint bleeds, and how it can provide additional information for target physiotherapy. We also learned about the importances of having good dental care at a young age and advocating for your child (not only about medical issues but also in the school system.) We were fortunate enough to attend many other sessions including clinical trials, managing stress with music therapy, and much more. Every time we attend an Inhibitor Summit, we are so eager to learn. We always wish we could stay longer.

COMMUNITY CHATTER

AND

PROS

“Learning Self-Infusion”

CONS

ver catch Jimmy Fallon on the Tonight Show? One of my favorite segments is Pros and Cons, where he chooses a topic and picks out positive key points about it. But with each positive, there comes a funny negative related to it. What better topic for this crowd than the pros and cons of learning self-infusion?

by Eric Lowe

I’ll take a stab at it. Sorry... I couldn’t resist!

PROS

CONS

When you get labs drawn, you and the phlebotomist have something in common to talk about.

If they don’t hit blood in 2.5 seconds, your coaching them on their job, and now the two of you have nothing to talk about.

Your confidence grows as you gain more experience hitting veins.

You start making cheesy remarks like, “I know infusions like the back of my hand.”

You get pretty well known as someone good with a needle.

All of your friends begin asking you for free tattoos and piercings.

You develop OCD-protective tendencies for your veins, so you can preserve them well.

Your veins now have their own theme song, “You Can’t Touch This.”

In choosing veins, you begin to go where no man (or woman) has gone before.

You’re using three mirrors to get there.

Learn to infuse at Inhibitor Family Camp, and you get a “big stick” award.

On the flight home from camp, TSA confiscates your stick.

For entertainment purposes only. See full disclaimer on page 4.

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FUN & INSPIRATION

Thrive

How to in Todayâ&#x20AC;&#x2122;s World and

By Matthew Manela, LICSW, LADC

ANGER

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Manage Your

FEATURE

n todayâ&#x20AC;&#x2122;s world we are put to the test every day. A typical day for many of us involves getting kids to school, picking them up from school, driving one to practice and then the other to Karate all while thinking about what to make for dinner and cooking dinner! This is only the beginning of the nightâ&#x20AC;Śnext comes homework, baths, making school lunches and bed! This is all after working an 8-hour day! This is a good day with no additional stressors and frustrations! Consider a not-so-good day where you hit traffic, are late for work, or forget an important appointment. How can people thrive and live their lives without becoming obsessed with anger? First, letâ&#x20AC;&#x2122;s start with why we get angry. Anger is a secondary emotion that is triggered when we are afraid of something negative happening and blame someone or something for the negative situation that occurred. We then personalize the negative

event and see the person or thing as causing the event. Anger serves as a response to protect ourselves from being harmed. In addition, we continue to stay angry because we are having a hard time accepting the event for what is. It is our reaction to the event that triggers and maintains our anger. The problem with anger is that, while we are angry, we are not living life to its fullest in a way that is important to us. In order to best illustrate how to cope with anger, I developed a 12-step model to manage your anger.

Step 1: Recognize that we are powerless over our initial response to anger. The first step to anger management is to accept that we are powerless over our initial reaction to anger. Through our life experiences, we have developed automatic thoughts that are based on the events of our lives. Over time, these events

FEATURE

ANGER INVENTORY: FEELINGS: 0 HUNGER 0 EXHAUSTION ACTIVITIES: 0 DRIVING 0 WORKING 0 CONVERSING

have created a response to protect us from being harmed. Unfortunately, we can’t control our automatic thoughts but we can observe and notice our thoughts. It does not matter what your initial thought is, but rather, what you do with the initial thought that dictates what emotion you will experience. If your next thoughts are focused around blame and being wronged, then you will feel angry. If your thoughts are more neutral then you will feel an emotion that corresponds to your thought process. The goal in this step is to begin to observe your thoughts and your reactions to the events in your life and begin to identify patterns.

Step 2: Willingness to accept that adjusting perspective is a necessary part of changing the anger-response cycle. My 12 step model follows the philosophy that the event is not the cause of your anger, rather, your thoughts about the event are responsible for maintaining anger. In other words, life has a series of ups and downs, no one made you angry but rather you allow yourself to continue to be angry. This may be a very different way of thinking about anger than you have previously considered. As a result, shifting to this new way of thinking may be challenging. That is the reason Step 2 is about getting ready to adjust your thoughts and take more responsibility around your anger. One of the most difficult parts of learning to manage your anger is making a decision to change. The reason it is so hard is because we can become obsessed over our unmet needs. When we are angry we may find it impossible to think of anything except that another is “wrong” and we are “right”. The question that I often get is “what if you are right?.” The problem with this question is that anger has nothing to do with whether you are “right.” The question you need to ask yourself is whether or not you want to reduce and/or let go of your anger. To help make this decision

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you will need to think about and be clear about what is important to you. You need to ask yourself ‘how do I want others to see me?’ “What do I want my relationship with this person or this company to look like?” “How do I want to be remembered?” “What are my values and do these words and actions move me towards or away from meeting my values?”

Step 3: Make an inventory on what triggers us to get angry. Once you have made the decision to reduce your anger, the next step is to observe your thoughts, expectations, needs and events that triggered your anger. In order to understand your anger and what triggers it, it is helpful to explore whether the thought that you are having is helping you move towards, or away from your values. You want to explore if you are trying to control the situation with your anger, or if you are just reacting to the situation? Other factors to consider are the circumstances around you. Notice if anger episodes increase when you are tired or hungry. Notice what you were doing right before an anger episode and what impulses you experience. The reason for taking an Anger inventory is because it is your thoughts and perspectives that get you angry, not the event itself. If this is true, then knowing your triggers is a necessary step for anger reduction.

Step 4: Come to a full understanding of the Fear = Anger connection. One of the biggest anger triggers is fear. The fear that I am referencing is based on our past experiences and are triggered in the present. For example, an individual with a learning disability may have been removed from their mainstream classroom as a

child. A fear of not being liked or being different may develop. As an adult, when an event triggers the feeling of being left out an individual may become angry to protect themselves from being hurt. It is important to explore and identify your pain and how your fear tricks you in to thinking you can do something about it, by blaming others. When we get angry, we are trying to control the

event or person we see as causing our anger, instead of accepting it. In this step, we need to recognize how we are avoiding our pain. We need to decide what changes will bring us closer to being the person we want to be. This does not mean that we are powerless to change the negative aspects of our situation in the future, but rather, recognizing that staying angry does not help make the pain better over the long term.

Continues on page 26.

FEATURE

TAYLOR, JACK, BOB, HENRY, SID, JUSTIN, CHASE, AND KALI (Clockwise from top right) Taylor has congenital FVII deficiency; Jack, Bob, Sid, Justin, and Chase have congenital hemophilia with inhibitors; Kali has Glanzmann’s thrombasthenia

Rooted in effective bleed control Reaching to help more patient types than any other factor product • 30 years of research and long-term clinical experience has gone into NovoSeven® RT – Compassionate use, also known as expanded access, began in 1988 – FDA approval received in 1999 • NovoSeven® RT is used to treat more patient types than any other factor product – 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 deficiency – Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions – Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia • More than 70 trials and registries completed, with a commitment to ongoing research

Visit NovoSevenRT.com today to learn more.

Indications and Usage NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for: • 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. Warnings and Precautions • 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. • 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. 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). 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.

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

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. 0715-00027616-1 September 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 and Drug Interactions]. 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, postoperative 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. PT (sec) PT versus FVII:C INR: NovoSeven® has demonstrated the ability to 14 normalize INR. However, INR 13 values have not been shown 12 to directly predict bleeding 11 outcomes, nor has it been 10 possible to demonstrate the 9 impact of NovoSeven® on 8 bleeding times/volume in 7 models of clinically-induced 6 bleeding in healthy volunteers who had received Warfarin, 5 when laboratory parameters 4 (PT/INR, aPTT, thromboelas3 togram) have normalized. 2 aPTT: While administration of 1 NovoSeven® shortens the 0 30 40 prolonged aPTT in hemo0 10 20 philia A/B patients with FVII:C (unit per mL)

inhibitors, normalization has usually not been observed in doses shown to induce clinical improvement. Data indicate that clinical improvement 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 Reactions Body as a whole Fever Platelets, Bleeding, and Clotting Fibrinogen plasma decreased Cardiovascular Hypertension

# of adverse reactions (n=1,939 treatments)

(n=298 patients)

# of patients

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 perioperative 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 Preferred Term Organ Class Immune system Hypersensitivity (including anaphylactic shock, disorders 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) DRUG INTERACTIONS: Avoid simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates. The risk of a potential interaction between NovoSeven ® RT and coagulation factor concentrates has not been adequately evaluated in preclinical or clinical studies. Do not mix NovoSeven ® RT with infusion solutions. Thrombosis may occur if NovoSeven ® RT is administered concomitantly with Coagulation Factor XIII. USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. NovoSeven ® RT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment of rats and rabbits with NovoSeven ® in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. At 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg per kg body weight of NovoSeven® gave birth successfully, however, two of the 23 litters died during the early period of lactation. No evidence of teratogenicity was observed after dosing with NovoSeven ®. Labor and Delivery: There are no adequate and well-controlled studies in labor, delivery, and postpartum periods. NovoSeven® RT has caused thrombosis when used to control post-partum hemorrhage. Nursing Mothers: It is not known whether NovoSeven ® RT is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Clinical trials enrolling pediatric patients were conducted with dosing determined according to body weight and not according to age. Hemophilia A or B with Inhibitors: During the investigational phase of product development NovoSeven ® was used in 16 children aged 0 to <2 years for 151 bleeding episodes, 27 children aged 2 to <6 years for 140 bleeding episodes, 43 children aged 6 to <12 for 375 bleeding episodes and 30 children aged 12 to 16 years for 446 bleeding episodes. In a double-blind, randomized comparison trial of two dose levels of NovoSeven ® in the treatment of joint, muscle and mucocutaneous hemorrhages in hemophilia A and B patients with and without inhibitors 20 children aged 0 to <12 and 8 children aged 12 to 16 were treated with NovoSeven ® in doses of 35 or 70 micrograms per kg dose. Treatment was assessed as effective (definite relief of pain/tenderness as reported by the patient and/or a measureable decrease of the size of the hemorrhage and/or arrest of bleeding within 8 hours [rated as excellent = 51%], within 8-14 hours [rated as effective = 18%] or after 14 hours [rated as partially effective = 25%]) in 94% of the patients. NovoSeven® was used in two trials in surgery. In a dose comparison 22 children aged 0 to 16 years were treated with NovoSeven ®. Effective intraoperative hemostasis (defined as bleeding that had stopped completely or had decreased substantially [rated as effective = 86%] or bleeding that was reduced but continued [rated as partially effective = 9%]) was achieved in 21/22 (95%) patients. Effective hemostasis was achieved in 10/10 (100%) patients in the 90 mcg/kg dose group and 10/12 (83%) in the 35 mcg/kg dose group at 48 hours; effective hemostasis was achieved in 10/10 (100%) in the 90 mcg/kg dose group and 9/12 (75%) in the 35 mcg/kg dose group at 5 days. In the surgery trial comparing bolus (BI) and continuous infusion (CI) 6 children aged 10 to 15 years participated, 3 in each group. Both regimens were 100% effective (defined as bleeding has stopped completely, or decreased substantially) intra-operatively, through the first 24 hours and at day 5. At the end of the study period (Postoperative day 10 or discontinuation of therapy) hemostasis in two patients in the BI group was rated effective and hemostasis in one patient was rated as ineffective (defined as bleeding is the same or has worsened). Hemostasis in all three patients in the CI group was rated as effective. Adverse drug reactions in pediatric patients were similar to those previously reported in clinical trials with NovoSeven ®, including one thrombotic event in a 4 year old with internal jugular vein thrombosis after porta-cath placement which resolved. Congenital Factor VII deficiency: In published literature, compassionate use trials and registries on use of NovoSeven ® in congenital Factor VII deficiency, NovoSeven ® was used in 24 children aged 0 to <12 years and 7 children aged 12 to 16 years for 38 bleeding episodes, 16 surgeries and 8 prophylaxis regimens. Treatment was effective in 95% of bleeding episodes (5% not rated) and 100% of surgeries. No thrombotic events were reported. A seven-month old exposed to NovoSeven® and various plasma products developed antibodies against FVII and rFVIIa [see Clinical Trials Experience and Overdosage]. Glanzmann’s Thrombasthenia: In the Glanzmann’s Thrombasthenia Registry, NovoSeven ® was used in 43 children aged 0 to 12 years for 157 bleeding episodes and in 15 children aged 0 to 12 years for 19 surgical procedures. NovoSeven® was also used in 8 children aged >12 to 16 years for 17 bleeding episodes and in 3 children aged >12 to

16 years for 3 surgical procedures. Efficacy of regimens including NovoSeven ® was evaluated by independent adjudicators as 93.6% and 100% for bleeding episodes in children aged 0 to 12 years and >12 to 16 years, respectively. Efficacy in surgical procedures was evaluated as 100% for all surgical procedures in children aged 0 to 16 years. No adverse reactions were reported in Glanzmann’s thrombasthenia children. Geriatric Use: Clinical studies of NovoSeven ® RT in congenital factor deficiencies and Glanzmann’s thrombasthenia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 License Number: 1261 Novo Nordisk® is a registered trademark of Novo Nordisk A/S. NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. © 2015 Novo Nordisk 0715-00027826-1 8/15

Step 5: Compassion for others and not blaming them entirely allows us to be less angry. In this step we move from collecting information about our anger, to making changes in the way we are thinking about the situation. To do this, we need to reduce the amount of blaming we are doing and replace it with compassion. What is compassion? Compassion is looking at an event or situation the way it is and not the way that we created it to be. Looking at things objectively is a difficult process. To increase objectivity, we need to reduce judgements and be open to alternative ways to explain other’s behavior. One way to do this is to adopt the philosophy that most people ‘s intentions are generally good. The reason we judge people is because the mind has a natural instinct to see things in black and white or right and wrong. However, when challenging your thoughts you need to bring compassion to your understanding of the current situation. You need to keep in mind while you’re practicing these skills

that you don’t need to believe everything that the mind dishes up. Your job in this step is to try to bring compassion to what your mind comes up with. My suggestion is to practice this skill in places that only create simple frustrations. For example, try bringing compassion the next time you are waiting in a long line in the supermarket or in a traffic jam. Try focusing only on thoughts based on the facts of the situation.

Step 6: To identify that Anger-Triggering Thoughts are based on cognitive distortions (thinking errors). We recognize that these thoughts are based on assumptions and are not valid. The thing about stressful emotions is that they only stay with us when we are feeding them with new negative thoughts. When we feel angry, we usually add to the original thought. For example, if I become angry that my son lied to me about something, I don’t usually say “Ok that’s fine.” My next thought is usually something like this - “That little bugger, he is always doing this to me.” No matter what you say to yourself, most likely it is based on an assumption, which causes a thinking error that maintains your anger. These are called cognitive distortions. When you are using cognitive distortions, you are also fusing with your anger. That is, you see your thoughts as 100% true and are not able to separate from your thoughts. When you fuse with your thoughts, you are not open to anything except how you are “right. “In this step, you learn to identify when you are fusing with your thoughts and using cognitive distortions . The following is some examples of cognitive distortions; should statements, jumping to conclusions, magnification, and over generalization. There are others but these are the main ones that create and maintain anger.

Step 7: To challenge and accept our cognitive distortions and move forward towards our values. In this step, we are disproving the distortion and learning to separate from our thoughts. How can we separate from our thoughts?

LIFELINES for HEALTH

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In order to understand this concept you need to understand that we are not our thoughts and that our thoughts are not always true or accurate. In fact, thoughts are just thoughts. I might have a thought that I want a piece of cake but that does not magically make a piece of cake appear. The same rule applies to my thought that my coworker intentionally acted in a negative manner. Just because I think it, does not make it true. It may feel true and we may really convenience ourselves that it happened but without evidence, it’s not true. So what do we do with our thoughts? First, observe your thoughts and look at the facts. Next, notice your thoughts without giving them much attention. By just noticing your thoughts instead of feeding them you will begin the process of separating from your thoughts. You will begin to accept your thought. For example, let’s say that you are angry with a coworker. Which one feels better to you, my co-worker does not trust me or I am having a thought that my co-worker does not trust me. Telling yourself you are having a thought or noticing a thought allows you to accept your thought, which opens yourself up to more possibilities. It opens yourself up to looking at the issue in a different way and helps move towards actions that are important to you.

Step 8: To assert our needs and take responsibility for our actions. Now that we have started the process of separating from our thoughts, we need to determine if we need to communicate about them. We don’t always need to tell someone that we are angry. Sometimes it makes sense to tell someone about your anger and problem solve with the person. In the spaces below, I have identified reasons we should communicate/problem solve. 1.

To reduce the likelihood that you will hold onto a resentment

To reduce the chances that you will get angry at the same thing over and over again

To help others better understand your triggers

To help you accept the present

Gain clarity of your thoughts

To enhance understanding of your expectations

In deciding to engage in communication and problem-solving, we need to realize that we cannot expect others to act or think like ourselves. We can only take responsibility for our own actions and communicate what would be helpful for us while understanding that other people may not agree. When you communicate with someone you need to be willing to work with the person and have an open mind. Then together, we can begin to resolve an issue. For example, you decide to communicate your anger to someone for not understanding your needs. In order for that conversation to be helpful, you will need to be open to the other person’s point of view. If the two of you share your point of views with each other you are more likely to agree on a solution that you both are happy with. One tip when talking with someone, make sure you have done the other steps first. This way, you are clear why you are angry and you are not communicating while you are having angry thoughts. If you communicate while you are still angry your communication and ability to problemsolve suffers. We have a tendency to communicate things we don’t mean when we are still angry.

Step 9: To forgive or accept others and that our past resentments cause us to replay the same anger triggers over again. In this step we are working towards accepting a situation for what it is and/or we are forgiving the person or thing involved. The word forgiveness is tricky because most people see forgiveness as saying that “what you did is Ok.” For our purposes, forgiveness is the process of accepting the situation and letting go of the event and being able to move forward. Forgiveness is for you and not the other person. It helps you move on and live a valuable life. In addition, forgiveness is not the same as forgetting.

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For example, those who were alive for 9/11 know and remember the event like it was yesterday. I am sure you can tell me where you were when you heard the news. Although I have not forgotten, I have accepted the event and no longer hold on to the anger from that day.

and situation that you are participating in. Just like any other muscle you need to exercise your brain to learn to stay in the present. You will find if you practice staying present when you are not angry, then when you are tested, you will find it easier to work the anger management steps.

The question I am often asked is “How do we forgive?” By the time you get to forgiveness you are already on your way. You have already acknowledged your anger, identified the hurt, fear, and judgement, and separated, and communicated your thoughts. The next part is making a decision to accept the situation for what it is by using the skills previously discussed and move closer to your desired view of yourself.

Another skill learned in this step is to increase your flexibility and your openness to possibilities. This takes practice. You can practice these skills in places that don’t cause too much anger. Perhaps the next time you are in the supermarket and you are annoyed by the cashier, you can practice identifying as many possibilities of why the line is moving slow. See if you can come up with positive and negative reasons. The purpose of the exercise is to open your mind up to the possibilities. It is not to be right. The better you get at different possibilities the better you will be at being flexible in the future. It is important not to compare yourself to other people, life is not a competition. Comparing yourself to others makes it hard to stay positive about the present. Instead, focus on what you like about your situation instead of what you don’t like.

Step 10: The power of positive thinking and being in the present can help us maintain a more serene lifestyle. Now that you have accepted the situation, it is now important to maintain your progress. In this step you are working on keeping your thoughts in the present and focusing your attention on the event

Step 11: To continually take your inventory in order to maintain your hard work. This step focuses around the maintenance of your newly learned anger management skills. In order to maintain your hard work, you need to keep paying attention to your thoughts and feelings on a regular basis. Although, it is not possible to pay attention to your thoughts all the time, it is important to keep your values in the front of your mind and to stay focused on who you want to be, what you want your relationships with others to look like, and doing things that are important to you. Paying attention to your values allows you be open to different choices and possibilities. You also want to be aware of your triggers, thoughts, expectations and values. In this step you are focusing on what is important to you. The goal of this step is doing these things without feeding the anger tiger inside. It is important to be aware of what your barriers are to becoming the person you want to be. It is important to remind yourself of your values everyday so you can ask yourself, “Is this behavior and action towards or away from living the life I want to live?”

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Step 12: Practice these principles and make a commitment towards your values The final step is to help remind you to practice the principals on a regular basis in all areas of your life. It is important to practice these principles so when you get angry, (and you will get angry) you can handle your reaction and turn it around much faster. It’s important to remind yourself that it is up to you whether you will be driving yourself towards your values, or whether you will go on a detour. If there are barriers blocking your values, then you need to strengthen those skills by practicing. Practicing will help you to remove the barriers. One thing to remember is that anger management is not an abstinence model. You will get angry but practicing will help maintain the speed that you accept the event or increase your ability to move quickly, let go of the anger, and go back to living a life that brings you enjoyment. Here are the skills for a quick review: 1.

Reduce judgments

Bring compassion to different situations

Accept events for what they are

Reduce expectations of others to think and act in the same way as you do

Practice flexibility when things don’t go as planned because they won’t

Things don’t need to be done perfectly or “correctly”

Open your mind to other viewpoints and possibilities

Stay in the present

Forgive/accept people and situations for you and not others

10. Keep your values and your inventory in the front of your mind Anger can be an overwhelming emotion and it can be difficult to change the way we respond when we feel wronged. However, by practicing these 12 steps and learning how to manage your emotions, things might feel a little easier. In addition, these steps will help you to respond to things in a way that will help you achieve what is important to you including how we respond to others and how we see ourselves. These 12 steps are not a “cure all” and things do “stink” sometimes but by practicing these steps it may seem a little more possible to live a more productive and satisfying life.

Matt Manela is a Licensed, Independent, Clinical Social Worker, and a Licensed Alcohol and Drug Counselor who has developed, researched, and implemented his 12 Step Anger Management program. He received his bachelor’s degree from the University of Rhode Island and his master’s degree from Widener University. Matt has had positions as a clinical supervisor, clinical director, and full time private practice clinician. He is currently working at Mclean Hospital as a family therapist in a residential program for adolescents managing OCD and anxiety disorders. Matt has a small private practice where he conducts his successful anger management program. He is also an adjunct professor at Massasoit Community College.

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ithin the last 3 years there has been a dizzying array of products that are new and/or currently in trial for the treatment of hemophilia A and hemophilia B. It is truly an exciting time for our community! We urge you to gather as much information available from a variety of resources to discuss the best therapy options with your health care professionals.

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Fall 2016

*We would like to thank LA Kelley Communications for preparing and allowing us to share this chart reflective of the products currently available to the bleeding disorders community.

US Hemophilia Factor Brands by Company and Type Product Plasma Derived Plasma Derived

Manufacturer Manufacturer

Recombinant Recombinant

FVIII FVIII

FIX FIX

Baxalta

Advate Recombinate Adynovate

Rixubis

Bayer HealthCare

Kogenate FS Kovaltry

Biogen

Eloctate

Alprolix

CSL Behring

Helixate FS Afstyla

Idelvion

FVIII FVIII

FIX FIX

Inhibitor INHIBITOR

Hemofil M

Proplex T Bebulin VH

FEIBA VH

Monoclate-P Humate-P

Mononine

Grifols

Alphanate

AlphaNine SD Profilnine SD

Kedrion

Koate DVI

Aptevo Therapeutics

Inhibitor INHIBITOR

Ixinity

Novo Nordisk

Novoeight

Octapharma

Nuwiq

Pfizer

Xyntha

NovoSeven RT

BeneFIX

Baxalta is now part of Shire. Baxalta is now partisof Shire. *There is no consensus yet on what constitutes a prolonged halfRecombinate a first-generation product. Recombinate is a first-generation product. life product. standard half-life products have the same halfKogenate FS and Helixate FS are second-generation products. They are the Some same product. Kogenate FS and Helixate FS are second-generation products. life as some products marketed asNuwiq, prolonged half-life. half-life Advate, Adynovate, Afstyla, Alprolix, BeneFIX, Eloctate, Idelvion, Ixinity, Kovaltry, Novoeight, Rixubus, andThe Xyntha They are the same product. of a product may vary widely from patient to patient. Knowing are third-generation products.* Advate, Adynovate, Afstyla, Alprolix, BeneFIX, Eloctate, your individual half-life is important; have a pharmacokinetic *ThereIxinity, is no consensus on what constitutes a prolonged product. Some standard half-lifehalf-life products have the with Idelvion, Kovaltry,yet Novoeight, Nuwiq, Rixubus, and half-life (PK) test to determine your individual and discuss The half-life of a product vary widely fromyour patient to same as some products Xyntha arehalf-life third-generation products.*marketed as prolonged half-life. your HTC hematologist whichmay product best meets treatment needs. patient. Knowing your individual half-life is important; have a pharmacokinetic (PK) test to determine your individual halflife and discuss with your HTC hematologist which product best meets your treatment needs. ©©2016 Inc.All Allrights rightsreserved. reserved. 2016LA LAKelley KelleyCommunications, Communications, Inc. This chart shows all current products licensed for sale in the US. This chart shows all current products licensed for sale in the US.

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ANGRY Lately? by Dr. Gary McClain, PhD

LIFELINES for HEALTH

Fall 2016

Coping With Angry Feelings at Home

elt angry lately? If you’re human, the answer is probably yes. So the better question is: What did you do about it? Something? Nothing? The wrong thing? It’s only human to get angry. In fact, you’ve been getting angry since before you were even aware you could get angry; like that time when you were a few days old and you howled until the milk was delivered. Anger is just one more emotion along a whole range of emotions that are part of being human. Here’s what’s ironic. While anger is an emotion that comes naturally, it is also the emotion we often have the most trouble feeling and expressing. And the emotion we often have the most trouble dealing with in others. We live in a world where we often witness anger that seems to get out of control. This leads to outbursts and hurt feelings or worse. Life challenges bring up a lot of emotions, including anger. Living with a chronic condition, or living with someone who is living with a chronic condition, can certainly bring up a lot of anger. Whether the anger gets expressed or not, and what happens if it does, is complicated, to say the least.

FAMILY MATTERS

Really Mad? Talk Yourself Down! Here are some ideas on how to handle your own angry feelings: Count to ten. Yes, this is one of the oldest tricks in the book. You’ve probably even seen it on a sitcom or two. But I can tell you from personal experience that it works. Counting to ten gives you a chance to think, and to calm yourself down, before you react in a way you might regret later. While you’re doing that countdown, don’t forget to breathe. Step out of the story. Ask yourself if there is an old story behind your anger. If you hear yourself saying something like “this always happens to me” or “I never get what I want” then that’s a clue to a story you may be trying to repeat. React in the moment, to the current situation, and not to a situation in the past that this might remind you of. By staying in the moment, you will be more likely to keep that reaction from blowing up into something that it isn’t. Reconsider your expectations. What were you expecting (to happen, receive, hear)? And were your expectations realistic? Sometimes anger is the result of not having our expectations met. Having realistic expectations is a great way to avoid the disappointment that can lead to angry feelings. And remember: you’re not in control of everything. Isn’t that a relief? Get clear with yourself on why you’re feeling angry. Often, you can identify what is making you angry. Something that happened or didn’t happen. Something that someone else did or said. Situations that feel out of your control. So take a step back and look inside to see if you can identify what’s pushing your anger button. Other times you just feel bad about the challenges that come with a chronic condition, and just want to vent. Whatever the reason is, be aware of it. Look for the humor. Recognizing the humor in a situation goes a long way toward balancing out that rage-rush that anger can bring on, as well as help you to keep your perspective. How about having a good laugh about how life just seems to get in the way of our plans? Have a heart. Chronic conditions bring up all kinds of emotions. Accept your own feelings – all of them – and let

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yourself be human. Give yourself a break, and you’ll be that much more able to give others a break, too. Patience! We’re all in this together. Reach out for support. Talk to a friend or family member who can listen without judging you for your feelings or trying to tell you what to do. Vent if you need to. Let those angry feelings out. Take care of yourself. Are you placing the needs of others before your own needs? Not taking care of yourself can leave you feeling emotionally or physically depleted, and especially vulnerable to resentment that leads to angry feelings. Take time for yourself every day. Take a walk, listen to music, do something you enjoy. Feeling angry is only human. You don’t have to avoid feeling angry, and you don’t have to be controlled by your anger. You have a choice!

Use Anger Productively in Family Communications Now… let’s talk about anger that gets directed toward other family members. When one member of the family is living with a chronic condition, everybody is living with it. Day-to-day interactions at home can get tense sometimes. And when that happens, tempers can flare. Here’s how to communicate when you’re angry: Express your feelings with the “I word.” Start out the conversation with your partner or other family member by expressing how you feel. It can be helpful to use the “I” word and not the “you” word. Make the conversation about how you feel, not how you assume the other person is feeling. Take responsibility. Focus on the issue. Talking about your anger will be a lot more productive if you focus on the specific issue you are angry about. A bad day when you had plans. Something they said or did that caused you to feel hurt. Another change you have to make to accommodate your or a family member’s chronic condition. But not everything that has made you mad over the last 10 years. Caution: consistently talking about angry feelings as they arise will help you to avoid the big build-up that can lead to an explosion. Let your family member know what you need. Sometimes we just feel angry because of the challenges of life. No one knows this better than someone who is living with a chronic condition. You may need a little time to vent and get some support. Other times, the issue may be one that needs to be addressed with action. Your family member can’t read your mind. So tell each other what you need. The best way to promote peace is for everyone to be aware of each other’s hot buttons, and what everybody can do to either avoid pushing them, and how to get back on track after they have been pushed.

It’s not okay to make someone else feel like a punching bag. And you don’t have to feel like one. Sure, chronic conditions introduce lots of challenges and frustrations. At some point, it may be necessary to gently let your partner know you are willing to help, and listen, but that you aren’t there to be verbally abused. Repeat as needed.

Attend to any collateral damage. For example, if your kids had to watch their parents hollering at each other. That can be scary for kids. A few hugs may be in order, along with giving them an opportunity to talk about what it was like for them, followed by some reassurance. If friends or family members were within earshot (not to mention the neighbors), you may want to reach out to them as well.

And Help Family Members Express Their Anger And when you are on the receiving end of anger, here are some ideas that might help: Listen. When your partner or family member directs anger toward you, your first reaction may be to put up a barrier or to become defensive. Try to remain calm and open. One way to do this is to remind yourself that they may be having a bad day and need to vent. But it may also be possible that they need to say something that, once you become aware of it, can

promote more peace and harmony in your relationship. Listen and learn. Help the other person identify the issue. Your partner or family member may not be crystal clear about what he or she is angry about. One way to help keep the anger from escalating, and potentially help to identify what is bothering them, is by asking a simple question: “How can I help you?” This shows you are listening and care. And by asking it, your family member may be able to identify what’s at stake, or to realize they simply need a listening ear. Talk. Listen. Understand. Don’t expect to solve. Anger doesn’t always lead to a solution. Sometimes the lack of a solution is what leads to the anger in the first place. Be okay with sharing feelings and understanding each other. Be okay with acknowledging each other’s anger. Recognize what is in your control and what is not in your control, what can and can’t be changed, where you agree, and where you agree to disagree.

Caution: Unexpressed anger can lead to depression. Depression is sometimes referred to as anger turned inward. Create an environment at home in which it’s okay to talk about feelings. Watch your children for signs of depression! Symptoms can include withdrawing, loss of interest, changes in eating or sleeping habits. It may be time to sit down and have a talk. Remember: Compassion is a boomerang. Show love to yourself by feeling how you feel and not denying your own emotions. Show love to your family members by being willing to hear how they are feeling, even when the conversation isn’t so easy to listen to. That’s compassion. How about starting the conversation with: “I love you.”

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

My Life, Our Future

Valuable Opportunity Coming to an End

“

y Life, Our Future”. Maybe it’s a phrase you’ve heard while visiting your HTC, or in the hemophilia community. Or maybe you’ve never heard the phrase before. My Life, Our Future (MLOF) refers to an initiative put together by four partners: Bloodworks Northwest (formerly Puget Sound Blood Center), American Thrombosis and Hemostasis Network (ATHN), National Hemophilia Foundation (NHF) and Biogen.

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Its purpose is two-fold: • •

MLOF provides no or low cost genotyping (another word for genetic testing) of the factor VIII or IX gene for families with hemophilia It forms a nationwide research repository of biological samples from families with hemophilia which can be used for further hemophilia research

by Meadow Heiman, MS, LCGC Indiana Hemophilia & Thrombosis Center

The My Life, Our Future project has been enrolling boys and men with hemophilia since 2013 and has almost 5,000 individuals currently participating in the research repository. Now, in the last half of 2016, the MLOF project has opened this initiative to offer no or low cost genotyping for female family members of males with hemophilia as well. Genotyping can determine a female family memberâ&#x20AC;&#x2122;s carrier status. The My Life, Our Future project is anticipated to close at the end of 2017 so families have just a little over a year left to participate. Your participation would provide you with a clinical genetic test result identifying the genetic alteration in

your factor VIII or IX gene causing your hemophilia which is necessary in order to provide accurate carrier testing to female family members. Whether the genotyping is no or low cost is dependent on your specific hemophilia treatment center. If you participate in the research repository portion of the project you will help researchers learn more about specific alterations in the factor VIII or IX genes and their impact on hemophilia including their correlation with inhibitor development. Depending on the research proposed in the future, additional research could include learning about the development of inhibitors, the treatment of inhibitors, living with an inhibitor, etc.

PARTICIPATE,

contact your local hemophilia treatment center (HTC). There are 96 HTCs in the United States that are currently participating in the MLOF project. If your HTC is not participating they may be able to refer you to another HTC that can help you enroll. When you choose to participate in the MLOF project, you will receive the no to low cost genotyping and will have the option of participating in the research repository. If you have any questions regarding the My Life, Our Future project you are encouraged to contact your HTC to inquire about whether they are enrolling in the project. Please visit the MLOF website at www.mylifeourfuture.org for more information including a list of participating HTCs.

BLOODLINES

To patients on Helixate速 FS Antihemophilic Factor (Recombinant)

You can continue Factor VIII treatment with Kogenate速 FS Antihemophilic Factor (Recombinant) INDICATIONS Kogenate速 FS Antihemophilic Factor (Recombinant) and Helixate FS速 Antihemophilic Factor (Recombinant) are medicines used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Kogenate FS and Helixate FS are used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS or Helixate FS when you have surgery. Kogenate FS and Helixate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS and Helixate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly. Kogenate FS and Helixate FS are not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION

You should not use Kogenate FS or Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS or Helixate 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 or Helixate 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.

Important facts about Helixate FS and Kogenate FS The factor (active pharmaceutical ingredient and formulation) contained in Helixate FS is made by Bayer Bayer’s Kogenate FS and Helixate FS are bioequivalent—they contain the same factor Bayer’s supply agreement with CSL (the company that markets and distributes Helixate FS) will continue through December 31, 2017, at which point Helixate FS will no longer be manufactured Bayer will continue to manufacture Kogenate FS Kogenate FS and Helixate FS have different reconstitution systems

Kogenate FS is covered by all major insurance companies You can check with your insurance provider for any recent changes to the coverage status of Helixate FS

To learn more, visit ContinueFactor.com. Talk to your healthcare provider to see if Kogenate FS may be appropriate for you.

S:9.875”

IMPORTANT SAFETY INFORMATION (CONT’D) Your body can make antibodies, called “inhibitors,” against Kogenate FS or Helixate FS, which may stop Kogenate FS or Helixate 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 and Helixate 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 or Helixate FS. For additional important risk and use information, please see the Brief Summaries for these products on the following pages. You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. Helixate FS is a registered trademark of CSL Behring LLC. © 2016 Bayer. All rights reserved. Printed in USA 10/16 PP-575-US-2705

Kogenate FS (kō-jen-ate) Antihemophilic Factor (Recombinant) Formulated with Sucrose Brief Summary of Patient Product Information This leaflet summarizes important information about Kogenate FS with vial adapter. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Kogenate FS. If you have any questions after reading this, ask your healthcare provider. Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center. What is Kogenate FS? Kogenate FS is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally. Kogenate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children. Kogenate FS is not used to treat von Willebrand Disease. Who should not use Kogenate FS? You should not use Kogenate FS if you • are allergic to rodents (like mice and hamsters). • are allergic to any ingredients in Kogenate FS. Tell your healthcare provider if you are pregnant or breast-feeding because Kogenate FS may not be right for you. What should I tell my healthcare provider before I use Kogenate FS? Tell your healthcare provider about all of your medical conditions. Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies. Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease. Tell your healthcare provider if you have been told that you have inhibitors to factor VIII (because Kogenate FS may not work for you). What are the possible side effects of Kogenate FS? 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 • decrease in blood pressure Your body can also 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) • Infections from implanted injection device

Tell your healthcare provider about any side effect that bothers you or that does not go away. Finding veins for injections may be difficult in young children. When frequent injections are required your child's healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections. These are not all the possible side effects with Kogenate FS. You can ask your healthcare provider for information that is written for healthcare professionals. How do I store Kogenate FS? Do not freeze Kogenate FS. Store Kogenate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light. Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored. Throw away any unused Kogenate FS after the expiration date. Do not use reconstituted Kogenate FS if it is not clear to slightly cloudy and colorless. What else should I know about Kogenate FS and hemophilia A? Medicines are sometimes prescribed for purposes other than those listed here. Do not use Kogenate FS for a condition for which it is not prescribed. Do not share Kogenate FS with other people, even if they have the same symptoms that you have. This leaflet summarizes the most important information about Kogenate FS. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Kogenate FS that was written for healthcare professionals. Resources at Bayer available to the patient: For Adverse Reaction Reporting contact: Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937) Contact Bayer to receive more product information: Kogenate FS Customer Service 1-888-606-3780 Bayer Reimbursement HELPline 1-800-288-8374 For more information, visit www.kogenatefs.com

Bayer HealthCare LLC Whippany, NJ 07981 USA U.S. License No. 8 (License Holder: Bayer Corporation) http://www.kogenatefs.com/ 6809903BS

Helixate FS (he-liks-āt) Antihemophilic Factor (Recombinant) Formulated with Sucrose Brief Summary of Patient Product Information This leaflet summarizes important information about Helixate FS. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Helixate FS. If you have any questions after reading this, ask your healthcare provider. Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center. What is Helixate FS? Helixate FS is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally. Helixate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Helixate FS when you have surgery. Helixate FS can reduce the number of bleeding episodes when used regularly (prophylaxis). Helixate FS can reduce the risk of joint damage in children. Helixate FS is not used to treat von Willebrand Disease. Who should not use Helixate FS? You should not use Helixate FS if you • are allergic to rodents (like mice and hamsters). • are allergic to any ingredients in Helixate FS. Tell your healthcare provider if you are pregnant or breast-feeding because Helixate FS may not be right for you. What should I tell my healthcare provider before I use Helixate FS? Tell your healthcare provider about all of your medical conditions. Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies. Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease. Tell your healthcare provider if you have been told that you have inhibitors to factor VIII (because Helixate FS may not work for you). What are the possible side effects of Helixate FS? You could have an allergic reaction to Helixate 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 • decrease in blood pressure Your body can also make antibodies, called “inhibitors,” against Helixate FS, which may stop Helixate 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 Helixate FS are • Local injection site reactions (pain, swelling, irritation at infusion site) • Infections from implanted injection device

Tell your healthcare provider about any side effect that bothers you or that does not go away. Finding veins for injections may be difficult in young children. When frequent injections are required your child’s healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections. These are not all the possible side effects with Helixate FS. You can ask your healthcare provider for information that is written for healthcare professionals. How do I store Helixate FS? Do not freeze Helixate FS. Store Helixate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Helixate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light. Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored. Throw away any unused Helixate FS after the expiration date. Do not use reconstituted Helixate FS if it is not clear to slightly cloudy and colorless. What else should I know about Helixate FS and hemophilia A? Medicines are sometimes prescribed for purposes other than those listed here. Do not use Helixate FS for a condition for which it is not prescribed. Do not share Helixate FS with other people, even if they have the same symptoms that you have. This leaflet summarizes the most important information about Helixate FS. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Helixate FS that was written for healthcare professionals.

Manufactured by: Bayer HealthCare LLC Whippany, NJ 07981 USA U.S. License No. 8 (License Holder: Bayer Corporation) Distributed by: CSL Behring LLC Kankakee, IL 60901 USA Mix2Vial™ is a trademark of West Pharmaceutical Services, Inc. in the United States. 6908300BS

How to Approach a 504, (or any other meeting at your child’s school)

For parents, the process of going into the school for a meeting produces anxiety, if not some level of fear. So often, it is one or two parents entering a room, quite often filled with multiple educators, including teachers, special educators, nurses, specialists, counselors etc. The process can be daunting and intimidating. Acronyms like IEP, LRE, FAPE are thrown around and parents frequently don’t know what those acronyms mean. As an Evaluation Team Chair, I see parents’ frustration, or even worse them disconnect from the meeting process altogether. This often produces tension amongst the Team members and parents feel that they need to come to a meeting with their defenses up

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and ready to battle! Complicating matters is that often a school team is uninformed about the bleeding disorder community and the impact a bleeding disorder has on a child’s education.

When parents come to a meeting with an initial sense of anger or frustration, the emotional outcome of the meeting is not going to be productive or what is in the best interest of the child and is most likely to fracture the entire team process. As the person who facilitates the IEP meeting, I generally can sense the direction the meeting is going to go when I introduce myself to the parents to bring them into the meeting room. Disposition and attitude of the

parents are generally evident upon this first greeting as is the attitude and disposition of the school team. It is extremely important that the school based team and the family work together in the education process to strengthen the partnership between home and school. Research demonstrates that children perform better in school when parents are more informed and involved in their education process. Additionally, this involvement fosters relationships with the teachers, nurses and specialists that help keep them informed of your child’s current medical/emotional needs!

IEP Meeting

by Lisa Cosseboom, M.Ed. & C.A.G.S School Psychologist & Special Education Evaluation Team Chairperson

Common Educational Terms to be familiar with: IDEA: Individuals with Disabilities Education Improvement Act (IDEA), which is Public Law 108-446 (generally referred to as the Individuals with Disabilities Education Act.) IDEA is the Federal special education law that provides a free appropriate public education in the least restrictive environment to all eligible children with disabilities.

IEP: Individualized Education Program. A written plan of a student’s individual special education program & related services with accommodations and measurable goals & objectives. ADA: Americans with Disabilities Act

FAPE: Free and Appropriate Public Education. Special education services and related services are provided to the student at no cost to the family.

LRE: Least Restrictive Environment. A student who has a disability should have the opportunity to be educated with non-disabled peers to the greatest extent appropriate.

APE: Adaptive Physical Education. A program of games and sports suited to the interest and capabilities and needs of students with disabilities who can not successfully participate in a regular education program.

504: A section of the rehabilitation act in which a student requires accommodations to access the curriculum or environment. 504 Plan: A 504 (ADA) Plan is a plan developed to ensure that a child who has a disability identified under the law receives accommodations that will ensure their academic success and access to the learning environment.

Differences between IEP and 504 Plan:

On an IEP, a student is receiving a modification of curriculum - specially designed instruction (i.e. learning to read, write, learn math differently than his/her peers.) Students also have accommodations as identified. The main difference between the two plans is the change in curriculum as well as the written documentation of measurable growth from year to year on the IEP. Both plans require a meeting yearly and both document accommodations identified.

Some things for parents to keep in mind when approaching a 504 or IEP Team meeting: 1. Approaching a meeting making demands will not be productive, even if the demands are legitimate or reasonable. It is important to model the behavior that you want drawn out in your child’s plan. 2. It is important to recognize that having the mentality of you vs. them is not useful. The Team approach should be a “we” approach. The parents are part of the Team!

3. When parents are asked about their thoughts or concerns, it is just as important to comment on the positive as well as the concerns. Positive comments go a long way to help facilitate a positive atmosphere!

4. Always keep in mind that the Team is there to focus on the child, not any one person’s agenda. 5. It is important for parents to be knowledgeable in the process. If you are unsure of the regulations of an IEP or 504 meeting, don’t be afraid to reach out to your school for clarification. 6. Provide information about your child’s bleeding disorder to the school-based team ahead of time so that they may make the time to read and research!

School Teams are invested in the process and want things to be positive and work together collaboratively with families. It is vital that all parties come to the table with the child and the child’s needs in mind in relationship to school functioning and success. Most educators go into the education field because of their love of children and their love of watching children grow and succeed. They work hard, long hours, for little pay and just want to make a difference for children and families. Approaching meetings positively will almost always yield positive results!

WHAT’S the PLAN?

Dedicated to Making a Difference in the Lives of People with Bleeding Disorders

anging up the phone with a young patient’s mother, I was elated to hear that our strategy to encourage her son to self-infuse was working. Two infusions in a row with no problems! Feeling bolstered by our progress, I began making preparations for their monthly order. Moments later, my phone buzzed with a text message from his mom.

deep and genuine connection with the bleeding disorders community, and I could not be more proud of our team across the country. That’s because with Matrix, you get more than just a specialty pharmacy. For us, it’s more than a job. It’s about standing together with those we serve to experience life’s journey with a bleeding disorder to its fullest.

“I just want you to know how grateful I am for everything you and your company have done for us, we would not be where we are today without you guys. Thank you for everything!”

When inhibitors occur on this journey, the clear path ahead can sometimes be replaced with trying to find your way through a thick fog. It’s often difficult to know where you’re going unless you’ve driven down the road before, and not everyone can follow the same directions to get there. At Matrix, we understand the importance of an individualized approach to your care, and we’re here to help make sense of all the twists and turns. Even with an inhibitor, a light can be found at the end of the tunnel.

Submitting the order form, I sat back in my chair and smiled. It was going to be a good day. As an employee of Matrix Health Group for over ten years, I’m very proud to say victories like the one above are not isolated moments. Our Care Coordinators share a

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By Justin Lindhorst, Regional Care Coordinator

One mom shares, “To have a company like Matrix is worth more than words can say. Matrix and all of its employees consistently deliver compassionate and dedicated service with a truly personal touch. Dealing with an inhibitor has so many hurdles and uncertainties, but we can always count on Matrix for their dedication, friendship, and priority for our son’s needs regardless of what his bleeding disorder and inhibitor throw at us.” This commitment to our patients runs from top to bottom. Whether clinical or clerical, every individual at Matrix Health Group is united under the common goal of helping our patients achieve improved health. Our clinicians are highly experienced in bleeding disorders, inhibitors, and related conditions. Whether it’s a specific assay, unique ancillary supply, or nursing support, our clinical team works to coordinate a truly individualized plan. Further, our friendly billing and reimbursement team assists with any insurance coverage concerns and secures authorizations and payment for treatment in a timely manner. From coast to coast, our care coordinators take great pride in serving the community and are heavily involved in the advocacy, fundraising and educational initiatives of their local chapters. The success of our organization lies not only in the fantastic people we employ, but also in five Guiding Principles that make up the foundation of our company. These include: Integrity, Dedication, Compassion, Enrichment, and Enthusiasm. Our Guiding Principles provide a bedrock and ethical framework for our entire organization. After all this time, I still wake up eager to begin my day. The patients I’ve had the privilege to work with over the past ten years have honestly become my second family. The many other industry professionals, chapter staff, and fellow community members I’ve come to know have become some of my greatest friends. I can say with no uncertainty that all

of us at Matrix Health Group look forward our community’s collective bright future, and we’d like nothing more than to be with you for the drive

Matrix Health Group is an accredited nationwide family of specialty pharmacies serving the bleeding disorders community. In addition to our pharmacy services, Matrix Health Group supports the community through education, advocacy, and financial support for local and national charitable organizations. Our quarterly newsletter, Matrix Health Group News is written to educate and empower the bleeding disorder community, and is provided free of charge to thousands across the country. Our annual scholarship program awards nine recipients with funding to assist with higher education. Our A Moment in Your Spectacular Life calendar shows the world life is spectacular, even with a bleeding disorder. From our Time For Fun children’s activity book, to our bi-annual publication in Spanish, we are committed to meeting the needs of people with bleeding disorders! To learn more about Matrix Health Group, please visit matrixhealthgroup.com, call us at 877-337-3002, like us on Facebook https://www.fb.com/matrixhealthgroup, or connect with your local Care Coordinator!

SPOTLIGHT

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

Editor Lisa Cosseboom, M.Ed., C.A.G.S

Publication Designer Eric Lowe

Contributing Writers Janet Brewer, M.Ed Lisa Cosseboom, M.Ed., C.A.G.S Marianna Grieco Meadow Heiman, MS, LCGC Justin Lindhorst Eric Lowe Matthew Manela, LICSW, LADC Dr. Gary McClain, PhD

Contributing Materials Laurie Kelley, LA Kelley Communications

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