Gastro Health Magazine Summer 2017 by Gastro Health

What You Need to Know About

Pancreatitis Easy Ways to Stay Hydrated in the

Summer

To Eat or Not to Eat?

Living with Diverticulitis

Cleansing for Colonoscopies Just Got Easier

Relieving Constipation

in Children

BECAUSE IN CHRONIC IDIOPATHIC CONSTIPATION

SUMMER 2017 ISSUE GASTRO MAGAZINE

You shouldn’t have to go to extremes

Does managing your constipation come with compromise? Trulance™ is a once-daily prescription medication for adults with Chronic Idiopathic Constipation (CIC) that helps provide more regular, well-formed bowel movements.

Talk to your doctor about Trulance today. Visit Trulance.com to learn more. What is Trulance? • About all the medicines you take, including Trulance (plecanatide) 3 mg tablets is a prescription and over-the-counter medicines, prescription medicine used in adults to treat a vitamins, and herbal supplements. type of constipation called chronic idiopathic constipation (CIC). “Idiopathic” means the cause Side Effects of the constipation is unknown. It is not known if Trulance is safe and effective in children less than Diarrhea is the most common side effect and can sometimes be severe. Diarrhea often begins within 18 years of age. the first 4 weeks of Trulance treatment. Stop IMPORTANT SAFETY INFORMATION taking Trulance and call your doctor right away if you get severe diarrhea. • Do not give Trulance to children who are less than 6 years of age. It may harm them. Tell your doctor if you have any side effect that • You should not give Trulance to children 6 years bothers you or that does not go away. These are to less than 18 years of age. It may harm them. not all the possible side effects of Trulance. For • Do not take Trulance if a doctor has told you more information, ask your doctor or pharmacist. that you have a bowel blockage (intestinal You are encouraged to report side effects to the obstruction). FDA. Visit www.fda.gov/medwatch or call Before you take Trulance, tell your doctor: 1-800-FDA-1088 or you can report side effects to Synergy Pharmaceuticals at 1-888-869-8869. • If you have any other medical conditions. • If you are pregnant or plan to become pregnant. Please see the following page for important It is not known if Trulance will harm your product information for patients. unborn baby. • If you are breastfeeding or plan to breastfeed. It is not known if Trulance passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Trulance.

This product information is intended for US audiences only. 1-888-869-8869 I Trulance.com Trulance™ is a trademark of Synergy Pharmaceuticals Inc.

Brief Summary of Medication Guide Trulance™ (troo’ lans) (plecanatide) tablets This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about Trulance? • Do not give Trulance to children who are less than 6 years of age. It may harm them. • You should not give Trulance to children 6 years to less than 18 years of age. It may harm them. What is Trulance? Trulance is a prescription medicine used in adults to treat a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown. It is not known if Trulance is safe and effective in children less than 18 years of age. Who should not take Trulance? • Do not give Trulance to children who are less than 6 years of age. • Do not take Trulance if a doctor has told you that you have a bowel blockage (intestinal obstruction). Before taking Trulance, tell your doctor about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if Trulance will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Trulance passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Trulance. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

T:10.87"

S:10.375"

How should I take Trulance? • Take Trulance exactly as your doctor tells you to take it. • Take Trulance by mouth, 1 time each day with or without food. • If you miss a dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time. • Trulance tablets should be swallowed whole. - Adults who cannot swallow Trulance tablets whole may crush the Trulance tablet and mix with applesauce or dissolve Trulance in water before swallowing. Trulance tablets may also be taken with water by adults through a nasogastric or gastric feeding tube. It is not known if Trulance is safe and effective when crushed and mixed with other foods or dissolved in other liquids. What are the possible side effects of Trulance? Trulance can cause serious side effects, including: • Diarrhea is the most common side effect of Trulance, and it can sometimes be severe. - Diarrhea often begins within the first 4 weeks of Trulance treatment. Stop taking Trulance and call your doctor if you develop severe diarrhea. These are not all the possible side effects of Trulance. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Trulance? • Store Trulance at room temperature between 68°F to 77°F (20°C to 25°C). • Keep Trulance in a secure place and in the bottle or blister pack that it comes in. • The Trulance bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle. • The Trulance bottle contains a polyester coil to help protect the tablets during shipping. Remove the polyester coil from the bottle and throw it away when you are ready to start taking Trulance. • Keep the container of Trulance tightly closed and in a dry place. • Safely throw away Trulance that is out of date or no longer needed. Keep Trulance and all medicines out of the reach of children. This is a brief summary of the most important information about Trulance. For more information: • Talk to your doctor • Visit Trulance.com • Call 1-888-869-8869 Date of Issue: 01/17 Manufactured for Synergy Pharmaceuticals Inc. New York 1-888-869-8869 I Trulance.com Trulance™ is a trademark of Synergy Pharmaceuticals Inc. Copyright 2017© Synergy Pharmaceuticals Inc. PP-TRU-US-0370

Gastro Health Welcomes You

Index

Pages

What You Need to Know About Pancreatitis

George Michael a music icon gone too soon

Easy Ways to Stay Hydrated in the Summer

To Eat or Not to Eat? Living with Diverticulitis

Cleansing for Colonoscopies Just Got Easier

Relieving Constipation in Children

Gastro Health Growth Provides Patients Expert Care and Convenience

Gastro Health – Committed to our mission

SUMMER 2017 ISSUE GASTRO MAGAZINE

This has been an exciting year for Gastro Health! Knowing that convenience and easy access to our expert physicians is important to our patients, we have ventured outside of MiamiDade County and further into South Florida – and Southwest Florida – with more locations. Gastro Health is now South Florida’s largest group of gastroenterology providers! We are pleased to have expanded our services in areas such as Wellington, Delray Beach, Coral Springs, Hollywood, Cooper City and Fort Myers. In addition, we have brought on more pediatric gastroenterologists and are now, also, South Florida’s largest pediatric gastroenterology provider. In this edition of Gastro Health Magazine, we provide you contact information for all of our expert physicians throughout Florida. In addition, this issue features a touching story about George Michael, a pop icon gone too soon, and how liver disease played a role in his death. Included within are other educational and informative articles on topics such as diverticulitis, constipation, an easier method of cleansing for colonoscopies and how to stay hydrated during the summer. The physicians and staff at Gastro Health remain committed to our mission to provide you and your family outstanding medical care and an exceptional healthcare experience. Thank you for your continued support. Alejandro Fernandez MBA, CMPE Gastro Health, LLC Chief Executive Officer

Designed and Published by:

9500 South Dadeland Boulevard Suite 200, Miami, FL 33156 T. 305.468.4180

www.gastrohealth.com

Copyright © 2015 Gastro Health, P.L. All rights reserved. This publication is published by Gastro Health, P.L., which is solely responsible for its contents. This information presented is intended only for residents of the United States. The material presented is intended only as informational, or as an educational aid, and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

Caring for you and those you love.

MISSION

To provide outstanding medical care and an exceptional healthcare experience.

GUIDING PRINCIPLE

We will treat each patient as a valued member of our immediate family.

CORE VALUES Care and Compassion Provide competent, individualized care in a professional, respectful and caring way. Teamwork Recognize each other as valuable members of our healthcare team by treating one another with loyalty, respect and dignity. Responsibility Provide excellent and efficient administrative, accounting, personnel and business management services. Value and Excellence Develop valuable ancillary services that improve our patientsâ&#x20AC;&#x2122; quality of care and customer experience.

Honesty and Integrity Communicate openly and honestly, build trust and conduct ourselves according to the highest ethical standards. Stewardship Attract and retain great talent and the finest gastroenterologists by actively promoting a professionally satisfying work environment. Accountability Maintain mutually beneficial relationships with top referring physicians, payers, employers and health systems using performance, outcome, as well as satisfaction measurements to demonstrate accountability and improvement in our care delivery.

I AM

HEPATITIS

CURED

I LET GO SUMMER 2017 ISSUE GASTRO MAGAZINE

In clinical studies, 96–99% of patients with genotype 1 who had no prior treatment were cured with just 12 weeks of therapy.*

* In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without cirrhosis (compensated), 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured. †Based on retail pharmacy prescription data (IMS NPA New to Brand™) for U.S. patients starting Hep C treatment with advanced treatment regimens (including direct-acting antiviral medicines) from 5/2011–9/2016. ‡This information is derived from IMS NPA, IMS NSP™, and IntegriChain® data; data reflect estimated patient starts for HARVONI from 10/2014–9/2016. || In the study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 97% (119 out of 123) of those with lower levels of the virus (less than 6 million IU/mL) who received HARVONI once daily for 8 weeks were cured. These studies did not include patients with advanced cirrhosis (decompensated) or those who have had a liver transplant.

ARE YOU READY TO LET GO OF THE UNCERTAINTIES OF HEP C?

HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

Now, more people have been prescribed HARVONI to cure their Hep C than any other advanced treatment regimen.† HARVONI has been prescribed to over a quarter of a million people.‡ HARVONI is a revolutionary treatment that’s one pill, once a day for 12 weeks.§ And for certain patients with genotype 1, HARVONI has been shown to be highly effective in as little as 8 weeks of treatment.|| Your Hep C Specialist will decide what treatment length is right for you. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. Talk to your Hep C Specialist about HARVONI.

IMPORTANT SAFETY INFORMATION What is the most important information I should know about HARVONI? HARVONI can cause serious side effects, including: • Hepatitis B virus reactivation: Before starting HARVONI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking HARVONI. What should I tell my healthcare provider before taking HARVONI? • Tell your healthcare provider about all of your medical conditions, including if you ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have severe kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects. What are possible side effects of HARVONI? Serious side effects may also include: • Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems. The most common side effects of HARVONI include tiredness, headache, and weakness. 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. Are you ready for HARVONI? Ask your Hep C Specialist if HARVONI is right for you and visit HARVONI.com or call 1-844-READY41. § For the majority of patients.

Please see Important Facts about HARVONI including important warning on the following page.

IMPORTANT FACTS (har-VOE-nee) MOST IMPORTANT INFORMATION ABOUT HARVONI

SUMMER 2017 ISSUE GASTRO MAGAZINE

HARVONI can cause serious side effects, Including: Hepatitis B virus reactivation: Before starting treatment with HARVONI, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during or after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B reactivation during and after you stop taking HARVONI.

ABOUT HARVONI HARVONI is a prescription medicine used to treat people 12 years of age and older (or weighing at least 77 pounds) with chronic (lasting a long time) hepatitis C genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In adults with GT 1 infection and advanced cirrhosis (decompensated) or with GT 1 or 4 infection with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

POSSIBLE SIDE EFFECTS OF HARVONI HARVONI can cause serious side effects, including: • Those in the “Most Important Information about HARVONI” section. • Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: • fainting or near-fainting • shortness of breath • dizziness or lightheadedness • chest pains • not feeling well • confusion • weakness • memory problems • extreme tiredness The most common side effects of HARVONI include tiredness, headache, and weakness.

This is only a brief summary of important information about HARVONI and does not replace talking to your healthcare provider about your condition and your treatment.

BEFORE TAKING HARVONI Tell your healthcare provider about all of your medical conditions, including if you: • have ever had hepatitis B virus infection • have liver problems other than hepatitis C infection • had a liver transplant • have severe kidney problems or are on dialysis • have HIV infection • are pregnant or breastfeeding, or plan to become pregnant or breastfeed If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-the-counter medicines, vitamins, and herbal supplements, and show it to your healthcare provider. • HARVONI and certain medicines may affect each other, or cause side effects.

GET MORE INFORMATION • This is only a brief summary of important information about HARVONI. Talk to your healthcare provider or pharmacist to learn more. • Go to HARVONI.com or call 1-844-READY41. • To learn about potential savings, call 1-855-7-MYPATH or go to HARVONI.com/support

These are not all the possible side effects of HARVONI. Tell your healthcare provider if you have any new symptoms while taking HARVONI.

HARVONI, the HARVONI logo, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners. ©2017 Gilead Sciences, Inc. All rights reserved. HVNC0861 05/17

What You Need to Know About Pancreatitis

BY Andres Gelrud, MD Gastroenterologist

New Knowledge and Treatment Options

he pancreas may not be an organ that you think about often. After all, it is deep in the abdominal cavity, so it is well protected, but also difficult to access. It produces specific hormones like insulin along with enzymes which enable the breakdown of food into very little pieces making the absorption into our body possible. But when the pancreas becomes inflamed, it can cause pancreatitis. Each year, there are more than 300,000 admissions to the hospital for the treatment of acute pancreatitis with an estimated cost greater than $2 billion.

TYPES OF PANCREATITIS

Pancreatitis can present in three different ways.

Acute pancreatitis - a painful and, at times, deadly condition. It can be caused by gallstones and alcohol abuse as well as other less likely conditions such as elevated triglycerides, high calcium blood levels, problems with the thyroid and even as a result of taking certain medications. Ninety percent of patients with acute pancreatitis will have a full recovery in three to four days; but, ten percent of patients may develop severe disease which can result in respiratory, renal, or cardiac complications, some of which can result in a high mortality rate if not addressed immediately. Recurrent acute pancreatitis when a patient develops two or more episodes of pancreatitis with a full recovery between attacks. When this happens, it is extremely important to try to find an underlying cause to enable proper treatment and prevent disease

progression. This patient population may have underlying genetic mutations that lead to more damage of the pancreas. Over the past ten years, significant progress has been made finding and understanding genetic mutations that lead to pancreatitis, both recurrent, acute and chronic. Approximately a third of patients with recurrent pancreatitis will go on to develop chronic pancreatitis.

Chronic pancreatitis - when

a patient has significant pancreatic disease due to persistent exposure to an underlying trigger such as smoking, alcohol, some metabolic disorders and genetic mutations. These patients frequently seek medical help with the main complaint of pain that can be very severe, difficult to treat and debilitating. Diabetes and exocrine pancreatic insufficiency may also be present in chronic pancreatitis. Cessation of the exposure or trigger is extremely important to prevent more episodes from happening.

CAUSES OF PANCREATITIS

In the past, we thought that all patients with recurrent, acute and particularly chronic pancreatitis were alcoholics, but we now know that only a small percentage of alcoholics will go on to develop pancreatitis (under ten percent). We now recognize that there are other causes for pancreatitis including smoking â&#x20AC;&#x201C; which is considered a major risk factor â&#x20AC;&#x201C; as well as genetics and autoimmune conditions.

TREATING PANCREATITIS

Recognizing and eliminating the underlying cause of pancreatitis is

essential. Genetic testing is now frequently implemented and coupled with genetic counseling. When genetic mutations are recognized we sometimes offer complete removal of the pancreas with auto transplantation of the insulin producing cells to prevent diabetes. This radical surgery is offered only to patients with debilitating disease. Also, endoscopic therapy or surgery can be utilized when patients have symptoms and fluid collection, stones or strictures. Dr. Andres Gelrud is a pancreatic expert with Gastro Health and the Director of The Pancreatic Disease Center at the Miami Cancer Institute, part of the Baptist Health System. He has a strong interest in adult and pediatric patients with pancreatic disorders including pancreatitis, complications of pancreatitis and high risk patients. To learn more about pancreatitis, visit www.animatedpancreaspatient.com or www.pancreasanimado.com (in Spanish).

BY: Flavia Mendes, MD Gastroenterologist

A MUSIC ICON GONE TOO SOON I SUMMER 2017 ISSUE GASTRO MAGAZINE

t’s one of those tunes you instantly recognized from the opening note. And then he fills your TV screen donning ripped jeans, a 5 o’clock shadow, mirrored aviator sunglasses and a memorable leather jacket, swaying his hips from side to side while playing the guitar. Faith was the #1 single in the United States in 1988 and propelled beloved pop star George Michael’s solo career onto center stage. George Michael sold more than 115 million records worldwide making him one of the best-selling music artists of all time. On Christmas day, 2016, he passed away at his country home in Oxfordshire, England. He was just 53 years old. The Faith singer’s cause of death was due to a combination of dilated cardiomyopathy with myocarditis and fatty liver, according to a coroner’s report. This means his heart was weakened, inflamed and enlarged leading to trouble pumping blood around his body properly. George’s liver also had abnormal amounts of unhealthy fat collections, which can be caused by many factors, including excessive alcohol use. While most people understand the causes of cardiovascular disease, few know anything about fatty liver and how it can lead to adverse health outcomes or — in its most severe stage — death. WHAT IS FATTY LIVER DISEASE? Fatty liver is a condition in which fat accumulates in the liver tissue causing inflammation and scarring over time. In the majority of cases, this condition is

benign and can be reversed. However, when it is left untreated, it can lead to Cirrhosis, which occurs when the liver becomes hardened and stops working properly resulting in death or the need for liver transplantation. CAUSES AND RISK FACTORS OF FATTY LIVER DISEASE There are several causes of fatty liver. Alcohol consumption in excess is a well-known cause of this condition. Even though most people that develop liver disease from alcohol have a long standing history of heavy alcohol use, not all heavy alcohol users will develop liver disease and, conversely, some individuals that are not considered heavy drinkers can end up with liver disease. Non-alcoholic fatty liver disease (NAFLD) is estimated to affect about 80 to 100 million people, making it the most common form of chronic liver disease in both adults and children. As the name suggests, this disease affects people who do not drink alcohol or drink only moderate amounts. Just like fatty liver caused by alcohol, the fat deposition in NAFLD can also cause inflammation and scarring, leading to cirrhosis.

PREVENTION The scariest part of fatty liver disease is that you usually are not aware that you have it. The good news is that it’s not difficult to diagnose and reversal is possible.

Non-alcoholic fatty liver disease is associated with risk factors such as being overweight, high blood pressure, high blood sugar levels (diabetes) and high cholesterol. These are also risk factors for cardiovascular disease and patients with NAFLD are at an even higher risk of developing heart problems.

THE ROLE LIVER DISEASE PLAYED IN GEORGE MICHAEL’S DEATH 10

WHAT CAN YOU DO TO PREVENT OR REVERSE FATTY LIVER? • Eat a well balanced diet with increased fruits, vegetables and fibers and avoid foods with high sugar and fat content. • Aim for a healthy weight. Don’t get discouraged as even a small amount of weight loss can help move the fat deposits out of the liver. Remember slow and maintained weight loss is better than quick and short-lived results! • Exercise! You don’t have to spend two hours at the gym every day. Fast walking for 30 minutes, at least 5 days a week is a great way to help your liver get rid of the fat. • Minimize or avoid alcohol consumption. • Avoid taking unnecessary medications and health supplements. • Routine check-ups are a great way to diagnose early and prevent complications. If you feel you are at risk, have a discussion with a Gastro Health physician and start giving the one organ you think least about a lot more attention. Dr. Flavia Mendes is a board-certified gastroenterologist and sees patients at Gastro Health’s Care Center 1, located at 7500 SW 87th Avenue, Suite 200, as well as at 15955 SW 96 Street, Suite 307.

“As the music dies, something in your eyes calls to mind the silver screen and all its sad good-byes”

BY Jessica Tejera Health & Weight Loss Coach

SUMMER 2017 ISSUE GASTRO MAGAZINE

Easy Ways to Stay Hydrated in the Summer

uring the summer months, most of us are at the beach or enjoying other outdoor activities. It’s important to be aware of your nutrition and hydration to cope with the warmer temperatures. This article will provide you with some easy ways to enjoy your summer while incorporating healthy strategies. Fluid Hydration Make sure you are drinking enough water by following an easy recommendation of 8 glasses of 8 ounces of water daily. Another way to calculate this is to divide your weight in pounds by 2 and drink the amount of ounces indicated. For example, a 150- pound male would need 75 ounces (150/2) of water per day. Watch for signs of dehydration such as: • Thirst • Headache • Dry or sticky mouth • Decreased urine output • Sleepiness or tiredness • Dizziness or lightheadedness Hydration through food You can also stay hydrated through the foods you eat. Only 70-80% of your hydration needs should come from water–

the other 20-30% can come from the foods we eat. Fruits and vegetables contain a significant amount of water. The ones listed below have the highest amount of water content:

Cucumber and Watermelon Salad

• Cucumbers- 97% • Celery- 96% • Tomatoes and radishes- 95% • Bell Peppers - 93% • Cauliflower and Watermelon- 92% • Spinach, Strawberries and Broccoli- 91% • Grapefruit- 90% • Oranges- 87%

Ingredients

Healthy Snacks When packing for a day at the beach or picnic, choose healthy foods and drinks. Try to avoid foods that are high in salt as they can have a dehydrating effect. Some tasty and healthy snacks include: raw or dry roasted nuts (10-12 nuts), fruits and vegetables, hummus, low-fat yogurt, grilled chicken salad, and sandwiches on wholegrain and low-calorie bread. If you want to “spruce up” water you can add limes, lemons, oranges, berries, or cucumbers. Also, having sparkling water can help you avoid carbonated drinks without the added calories.

10-serving recipes provided by allrecipes.com

1 small red onion, halved and sliced into thin half-moons 2 tablespoons lime juice, or more for taste 2 tablespoons extra-virgin olive oil 1 seedless watermelon, cut into cubes 2 cucumbers, cut into cubes 1 cup of crumbled feta cheese Optional: ½ cup mint leaves, sliced thinly Directions 1. Mix red onion with lime juice in a bowl; set aside to marinate at least 10 minutes. Stir olive oil into mixture. 2. Toss watermelon, cucumbers, and feta cheese together in a large bowl. Pour red onion mixture over watermelon mixture: toss and coat. Optional: Sprinkle mint over the salad.

Your Patient's Biologic Story

STARTS WITH THE

FIRST STEP MY FIRST STEP

"Today, I stop searching and start speaking to my doctor." STELARA®: The ﬁrst and only interleukin-12 and interleukin-23 inhibitor approved for the treatment of adult patients with moderately to severely active Crohn’s disease.

Indication STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have: • failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or • failed or were intolerant to treatment with one or more TNF blockers.

Important Safety Information Infections

Theoretical Risk for Vulnerability to Particular Infections

STELARA® (ustekinumab) may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections, some requiring hospitalization, were reported. In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and Listeria meningitis. Treatment with STELARA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated.

Individuals genetically deﬁcient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus CalmetteGuerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.

Please see additional Important Safety Information continued on next page.

For the treatment of adults with moderately to severely active Crohn’s disease who have failed or were intolerant to conventional therapy (but never failed treatment with a tumor necrosis factor [TNF] blocker) or have failed or were intolerant to treatment with one or more TNF blockers.

WITH A SINGLE IV INDUCTION DOSE1*

SUMMER 2017 ISSUE GASTRO MAGAZINE

(0.001≤P<0.01)

100

(P<0.001)

75 50 25

34% 29% 21%

56%

0 Placebo

n=53/247

STELARA® n=84/249

SECONDARY ENDPOINTS 70-POINT RESPONSE AT WEEK 3 AND 6§

Placebo

n=60/209

Proportion of Patients (%)

PRIMARY ENDPOINT CLINICAL RESPONSE (100-POINT) AT WEEK 6

STELARA® n=116/209

INDUCTION STUDY: TNF BLOCKER FAILURE†

INDUCTION STUDY: PREDOMINANTLY TNF BLOCKER NAÏVE‡

(N=741)

(N=627)

100

51%

65% n=135/209 P<0.001

n=106/209 P<0.001

STELARA®*

50 Placebo

32%

39%

n=66/209

n=81/209

Weeks

INDUCTION STUDY: PREDOMINANTLY TNF BLOCKER NAÏVE (N=627)

RAPID RESPONSE AS EARLY AS WEEK 31‡

* Weight-based induction dosage regimen: STELARA® 260 mg (weight 55 kg or less), STELARA® 390 mg (weight more than 55 kg to 85 kg), STELARA® 520 mg (weight more than 85 kg).1

† The TNF blocker–failure IV induction study was a double-blind, placebo controlled, randomized, phase 3 clinical trial in adult patients with moderately to severely active Crohn’s

disease who were intolerant to or failed TNF blocker therapy (N=741). In both induction studies, patients were randomized to receive STELARA® weight-based dosage regimen, STELARA® 130 mg IV, or placebo. The 130 mg IV dose is not an approved induction dose. The primary endpoint for both studies was clinical response at Week 6, which was defined as reduction in CDAI score of ≥100 points or CDAI score of <150. Moderately to severely active Crohn’s disease was defined as CDAI score between ≥220 and ≤450.1,2 ‡ The predominantly TNF blocker–naïve IV induction study was a double-blind, placebo-controlled, randomized, phase 3 clinical trial in adult patients with moderately to severely active Crohn’s disease (N=627). 69% of patients were TNF blocker naïve. Remaining population was patients previously exposed to, but who did not fail, treatment with TNF blockers. All patients in the study failed or were intolerant to conventional treatment (eg, azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids). In both induction studies, patients were randomized to receive STELARA® weight-based dosage regimen, STELARA® 130 mg IV, or placebo. The 130 mg IV dose is not an approved induction dose. The primary endpoint for both studies was clinical response at Week 6, which was defined as reduction in Crohn’s Disease Activity Index (CDAI) score of ≥100 points or CDAI score of <150. Moderately to severely active Crohn’s disease was defined as CDAI score between ≥220 and ≤450.1,2 § 70-point response was defined as reduction in CDAI score ≥70 points.1

Important Safety Information (cont’d)

Pre-Treatment Evaluation of Tuberculosis (TB)

Hypersensitivity Reactions

Evaluate patients for TB prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA®. Closely monitor patients receiving STELARA® for signs and symptoms of active TB during and after treatment.

STELARA® is contraindicated in patients with clinically signiﬁcant hypersensitivity to ustekinumab or excipients. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA®. If an anaphylactic or other clinically signiﬁcant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.

Malignancies

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA® in clinical studies. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. No cases of RPLS were observed in clinical studies of Crohn’s disease. If RPLS is suspected, administer appropriate treatment and discontinue STELARA®. RPLS is a neurological disorder, which is not caused by an infection or demyelination. RPLS can present with headache, seizures, confusion, and visual disturbances. RPLS has been associated with fatal outcomes.

STAY THE COURSE. A MAJORITY OF PATIENTS IN THE MAINTENANCE STUDY WERE IN CLINICAL REMISSION AT 52 WEEKS AFTER INDUCTION DOSE1* PRIMARY ENDPOINT: CLINICAL REMISSION

53%

STELARA® 90 mg subQ every 8 weeks†

Placebo (induction responders)‡

n=68/128 P<0.01

36% n=47/131

OTHER ENDPOINT: CLINICAL REMISSION IN TNF BLOCKER–NAÏVE POPULATION

STELARA 90 mg subQ every 8 weeks ®

Placebo (induction responders)‡

65%

n=34/52 P value is not statistically signiﬁcantt

49% n=25/51

MY FIRST STEP

“Believing I am moree than my disease...” se...” *The maintenance study was a double-blind, placebo-controlled, randomized phase 3 study. Patients randomized in this study were those who had a clinical response to STELARA® at Week 8 during induction studies. The primary endpoint was clinical remission at Week 44 which was deﬁned as CDAI score <150. Week 44 of the maintenance study or 52 weeks from initiation of the induction dose (8-week induction study + 44-week maintenance study=52 weeks).1 † Maintenance dosing of STELARA® consists of a 90-mg subQ injection every 8 weeks after the induction dose. ‡ All patients randomized to placebo in the maintenance study had a single dose of STELARA® IV induction dose.1

Important Safety Information (cont’d) Immunizations Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations recommended by current guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA®. Exercise caution when administering live vaccines to household contacts of STELARA® patients, as shedding and subsequent transmission to STELARA® patients may occur. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufﬁcient to prevent disease.

Please see additional Important Safety Information continued on next page.

Your Patient's Biologic Story

STARTS WITH THE

FIRST STEP For your adult patients with moderately to severely active Crohn's disease, visit

www.ChooseSTELARAFirst.com

MY FIRST STEP SUMMER 2017 ISSUE GASTRO MAGAZINE

“I will find my way back to me.”

Indication STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have: • failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or • failed or were intolerant to treatment with one or more TNF blockers.

Important Safety Information (cont’d) Concomitant Therapies

Most Common Adverse Reactions

The safety of STELARA® in combination with other immunosuppressive agents or phototherapy was not evaluated in clinical studies of psoriasis. Ultravioletinduced skin cancers developed earlier and more frequently in mice. In psoriasis studies, the relevance of findings in mouse models for malignancy risk in humans is unknown. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease studies, concomitant use of 6-mercaptopurine, azathioprine, methotrexate and corticosteroids did not appear to influence the overall safety or efficacy of STELARA®.

The most common adverse reactions (≥3% and higher than that with placebo) in psoriasis clinical trials for STELARA® 45 mg, STELARA® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. In psoriatic arthritis (PsA) studies, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA® when compared with placebo (3% vs 1% for both). In Crohn’s disease induction studies, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%).

Allergen Immunotherapy STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Please see Brief Summary on adjacent pages. Please see full Prescribing Information and Medication Guide for STELARA® at STELARAhcp.com. Provide the Medication Guide to your patients and encourage discussion. 060385-160920

References

1. STELARA® [prescribing information]. Horsham, PA: Janssen Biotech, Inc; 2016. 2. Data on ﬁle. Janssen Biotech, Inc.

Brief Summary of Prescribing Information for STELARA® (ustekinumab) STELARA® Injection, for subcutaneous use See package insert for Full Prescribing Information INDICATIONS AND USAGE: Psoriasis (Ps) STELARA® is indicated for the treatment of

adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) STELARA® is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX). Crohn’s Disease STELARA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have: • failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or • failed or were intolerant to treatment with one or more TNF blockers. CONTRAINDICATIONS: STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients [see Warnings and Precautions]. WARNINGS AND PRECAUTIONS: Infections STELARA® may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections were observed in subjects receiving STELARA® [see Adverse Reactions]. Serious infections requiring hospitalization occurred in patients with psoriasis, psoriatic arthritis and Crohn’s disease in clinical studies. In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and listeria meningitis. Treatment with STELARA® should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances. Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering STELARA®. Consider anti-tuberculosis therapy prior to initiation of STELARA® in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving STELARA® for signs and symptoms of active tuberculosis during and after treatment. Malignancies STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA® in clinical studies [see Adverse Reactions]. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [see Nonclinical Toxicology (13) in Full Prescribing Information]. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had pre-existing risk factors for developing non-melanoma skin cancer. All patients receiving STELARA® should be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment should be followed closely [see Adverse Reactions]. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA® [see Adverse Reactions]. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®. Reversible Posterior Leukoencephalopathy Syndrome One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. The subject, who had received 12 doses of STELARA® over approximately two years, presented with headache, seizures and confusion. No additional STELARA® injections were administered and the subject fully recovered with appropriate treatment. No cases of RPLS were observed in clinical studies of Crohn’s disease. RPLS is a neurological disorder, which is not caused by demyelination or a known infectious agent. RPLS can present with headache, seizures, confusion and visual disturbances. Conditions with which it has been associated include preeclampsia, eclampsia, acute hypertension, cytotoxic agents and immunosuppressive therapy. Fatal outcomes have been reported. If RPLS is suspected, administer appropriate treatment and discontinue STELARA®. Immunizations Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment with STELARA® or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA® because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease. Concomitant Therapies In clinical studies of psoriasis the safety of STELARA® in combination with other immunosuppressive agents or phototherapy was not evaluated. Ultraviolet-induced skin cancers developed earlier and more frequently in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone [see Nonclinical Toxicology (13.1) in Full Prescribing

STELARA® (ustekinumab) Information]. ADVERSE REACTIONS: The following serious adverse reactions are discussed elsewhere in the label: • Infections [see Warnings and Precautions] • Malignancies [see Warnings and Precautions] • Hypersensitivity Reactions [see Warnings and Precautions] • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Psoriasis The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies (14) in Full Prescribing Information]. Table 1: Adverse reactions reported by ≥1% of subjects through Week 12 in Ps STUDY 1 and Ps STUDY 2 STELARA® Placebo 45 mg 90 mg Subjects treated 665 664 666 Nasopharyngitis 51 (8%) 56 (8%) 49 (7%) Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%) Headache 23 (3%) 33 (5%) 32 (5%) Fatigue 14 (2%) 18 (3%) 17 (3%) Diarrhea 12 (2%) 13 (2%) 13 (2%) Back pain 8 (1%) 9 (1%) 14 (2%) Dizziness 8 (1%) 8 (1%) 14 (2%) Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%) Pruritus 9 (1%) 10 (2%) 9 (1%) Injection site erythema 3 (<1%) 6 (1%) 13 (2%) Myalgia 4 (1%) 7 (1%) 8 (1%) Depression 3 (<1%) 8 (1%) 4 (1%) Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation). One case of RPLS occurred during clinical studies [see Warnings and Precautions]. Infections In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of followup) [see Warnings and Precautions]. In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years), representing 8998 subjectyears of exposure, 72.3% of STELARA®-treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up). Malignancies In the controlled and non-controlled portions of psoriasis clinical studies (median follow-up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA®-treated subjects (0.52 per hundred subject-years of follow-up) [see Warnings and Precautions]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical studies were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in STELARA®-treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1 Psoriatic Arthritis The safety of STELARA® was assessed in 927 patients in two randomized, double-blind, placebo-controlled studies in adult patients with active psoriatic arthritis (PsA). The overall safety profile of STELARA® in patients with PsA was consistent with the safety profile seen in psoriasis clinical studies. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA®-treated patients when compared with placebo-treated patients (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical studies. Crohn’s Disease The safety of STELARA® was assessed in 1407 patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallelgroup, multicenter studies. These 1407 patients included 40 patients who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses. In Studies CD-1 and CD-2 there were 470 patients who received STELARA® 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo [see Dosage and Administration (2.3) in Full Prescribing Information]. Patients who were responders in either Study CD-1 or CD-2 were randomized to receive a subcutaneous maintenance regimen of either 90 mg STELARA® every 8 weeks, or placebo for 44 weeks in Study CD-3. Patients in these 3 studies may have received other concomitant therapies including aminosalicylates, immunomodulatory agents [azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX)], oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn’s Disease [see Clinical Studies (14.3) in Full Prescribing Information]. The overall safety profile of STELARA® was consistent with the safety profile seen in the psoriasis and psoriatic arthritis clinical studies. Common adverse reactions in Studies CD-1 and CD-2 and in Study CD-3 are listed in Tables 2 and 3, respectively.

STELARA® (ustekinumab)

Table 2: Common adverse reactions through Week 8 in Studies CD-1 and CD-2 occurring in ≥3% of STELARA®-treated patients and higher than placebo STELARA® Placebo 6 mg/kg single intravenous induction dose N=466 N=470 Vomiting 3% 4%

immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis. USE IN SPECIFIC POPULATIONS: Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to STELARA® during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972. Risk Summary Limited data on the use of STELARA® in pregnant women are insufficient to inform a drug associated risk [see Data]. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the human exposure at the maximum recommended human subcutaneous dose (MRHD). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Limited data on use of STELARA® in pregnant women from observational studies, published case reports, and postmarketing surveillance are insufficient to inform a drug associated risk. Animal Data Ustekinumab was tested in two embryofetal development toxicity studies in cynomolgus monkeys. No teratogenic or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab subcutaneously twice weekly or intravenously weekly during the period of organogenesis. Serum concentrations of ustekinumab in pregnant monkeys were greater than 100 times the serum concentration in patients treated subcutaneously with 90 mg of ustekinumab weekly for 4 weeks. In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly at exposures greater than 100 times the human subcutaneous exposure from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg. No ustekinumab-related effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age. Lactation Risk Summary There are no data on the presence of ustekinumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ustekinumab was present in the milk of lactating monkeys administered ustekinumab. Due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. Maternal IgG is known to be present in human milk. Published data suggest that the systemic exposure to a breastfed infant is expected to be low because ustekinumab is a large molecule and is degraded in the gastrointestinal tract. However, if ustekinumab is transferred into human milk the effects of local exposure in the gastrointestinal tract are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for STELARA® and any potential adverse effects on the breastfed child from STELARA® or from the underlying maternal condition. Pediatric Use The safety and effectiveness of STELARA® in pediatric patients have not been established. Geriatric Use Of the 5884 subjects exposed to STELARA®, a total of 306 were 65 years or older (183 patients with psoriasis, 65 patients with psoriatic arthritis and 58 with Crohn’s disease), and 34 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects. OVERDOSAGE: Single doses up to 6 mg/kg intravenously have been administered in clinical studies without dose-limiting toxicity. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately. PATIENT COUNSELING INFORMATION: Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) Infections Inform patients that STELARA® may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions]. Malignancies Inform patients of the risk of developing malignancies while receiving STELARA® [see Warnings and Precautions]. Hypersensitivity Reactions • Advise patients to seek immediate medical attention if they experience any signs or symptoms of serious hypersensitivity reactions and discontinue STELARA® [see Warnings and Precautions]. • Inform patients the needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex [see Dosage and Administration (2.4) in Full Prescribing Information] Immunizations Inform patients that STELARA® can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions]. Pregnancy Registry Inform patients that there is a pregnancy registry to monitor fetal outcomes of pregnant women exposed to STELARA® [see Use in Specific Populations]. Administration Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use. REFERENCES: 1 Surveillance, Epidemiology, and End Results (SEER) Program (www. seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973-2007) - Linked To County Attributes - Total U.S., 1969-2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission. Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044 US License No. 1864 at Cilag AG, Schaffhausen, Switzerland © Janssen Biotech, Inc. 2012 Revised: 09/2016 060387-160920

Other less common adverse reactions reported in patients in Studies CD-1 and CD-2 included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%).

SUMMER 2017 ISSUE GASTRO MAGAZINE

Table 3: Common adverse reactions through Week 44 in Study CD-3 occurring in ≥3% of STELARA®-treated patients and higher than placebo STELARA® 90 mg subcutaneous Placebo maintenance dose every 8 weeks N=133 N=131 Nasopharyngitis 8% 11% Injection site erythema 0 5% Vulvovaginal candidiasis/ 1% 5% mycotic infection Bronchitis 3% 5% Pruritus 2% 4% Urinary tract infection 2% 4% Sinusitis 2% 3% Infections In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia. In addition, listeria meningitis and ophthalmic herpes were reported in one patient each. Malignancies With up to one year of treatment in the Crohn’s disease clinical studies, 0.2% of STELARA®-treated patients (0.36 events per hundred patient-years) and 0.2% of placebo-treated patients (0.58 events per hundred patient-years) developed nonmelanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.2% of STELARA®-treated patients (0.27 events per hundred patient-years) and in none of the placebo-treated patients. Hypersensitivity Reactions Including Anaphylaxis In CD studies, two patients reported hypersensitivity reactions following STELARA® administration. One patient experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of patients receiving subcutaneous STELARA®). In addition, one patient experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous STELARA® dose (0.08% of patients receiving intravenous STELARA®). These patients were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour. Immunogenicity Approximately 6% of patients treated with STELARA® in psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were generally low-titer. In Crohn’s disease clinical studies, less than 3% of patients treated with STELARA® developed antibodies to ustekinumab. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. No ustekinumab-related serious hypersensitivity reactions were observed in psoriasis, psoriatic arthritis and Crohn’s disease clinical studies. In psoriasis studies, the majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies. The data above reflect the percentage of subjects whose test results were positive for antibodies to ustekinumab and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab with the incidence of antibodies to other products may be misleading. Postmarketing Experience The following adverse reactions have been reported during post-approval of STELARA®. 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 to STELARA® exposure. Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria) [see Warnings and Precautions]. Skin reactions: Pustular psoriasis, erythrodermic psoriasis. DRUG INTERACTIONS: Live Vaccines Avoid use of live vaccines with STELARA® [see Warnings and Precautions]. Concomitant Therapies In psoriasis studies the safety of STELARA® in combination with immunosuppressive agents or phototherapy has not been evaluated [see Warnings and Precautions]. In psoriatic arthritis studies, concomitant methotrexate use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease studies, immunomodulators (6-mercaptopurine, azathioprine, methotrexate) were used concomitantly in approximately 30% of patients and corticosteroids were used concomitantly in approximately 40% of patients. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA®. CYP450 Substrates The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, STELARA®, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation of STELARA® in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, monitoring for therapeutic effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) should be considered and the individual dose of the drug adjusted as needed [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Allergen Immunotherapy STELARA® has not been evaluated in patients who have undergone allergy immunotherapy. STELARA® may decrease the protective effect of allergen

To Eat or Not to Eat? Living with DIVERTICULITIS

f you have been diagnosed with diverticulitis, your first thoughts may be â&#x20AC;&#x153;How is this going to change my diet?â&#x20AC;? Thanks to new research, your dietary changes will not be as severe as you may have once thought, heard, or read. For decades, doctors recommended that people with diverticulitis avoid eating foods such as rice, corn, nuts, seeds, popcorn, beans and most raw fruits and vegetable skins because they believed the tiny particles from these foods may get lodged in the pouches and lead to an infection.

vegetables and whole grains soften waste and help it pass more quickly through your colon. This reduces pressure within your digestive tract which may help reduce the risk of diverticula pouches expanding outwards from the colon, forming and becoming inflamed. Lack of dietary fiber is now thought to be the main cause of diverticula. If you do not consume enough dietary fiber and the stool is hard, there may be more pressure or strain on the colon as muscles push the stool down which causes diverticula to occur.

While some doctors still recommend sticking to this type of diet, most physicians have abandoned that advice, as current research has demonstrated no evidence linking those foods with increased problems.

Unfortunately, diverticulitis is a condition that continues to leave some doctors scratching their heads; however, although there is no clear clinical evidence to prove a link between dietary fiber and diverticulosis, experts say the circumstantial evidence is convincing.

If you have diverticulitis, you should focus on eating a healthy diet that is high in fiber. High-fiber foods such as fruits,

Experts do not completely understand just yet why diverticulitis - the infection of at least one diverticula - occurs. They can

BY Richard Hernandez, MD Gastroenterologist

only tell us that the bacteria in the stool rapidly grows and spreads, causing an infection. The blockage, possibly by feces, is what physicians understand to cause the infection. If you have been diagnosed with diverticulitis, talk with your doctor or dietician who can help you make right decisions on any food-related questions. An expert can even make specific recommendations, provide recipes and help you find ways to enjoy the highfiber foods your diet needs.

Broward County

Jeffrey Kaner, MD Gastroenterologist

Robert Kaplan, MD Gastroenterologist

Alix Lanoue, MD Gastroenterologist

Adam Lessne, MD Gastroenterologist

Leon Maratchi, MD Gastroenterologist

Barry Migicovsky, MD Gastroenterologist CC24

Baaz Mishiev, MD Gastroenterologist CC24

Enrique Molina, MD Gastroenterologist CC24

Joel Stengel, MD Gastroenterologist

David Weiss , MD Gastroenterologist

CC24

Douglass Weissman, MD Gastroenterologist CC23

SUMMER 2017 ISSUE GASTRO MAGAZINE

Lee County

Andree A. Dadrat, MD Gastroenterologist CC25

Mark S. Oâ&#x20AC;&#x2122;Konski, MD Gastroenterologist CC25

James W. Penuel, MD Gastroenterologist CC25

Paul Yudelman, MD Gastroenterologist CC25

Miami Dade County

Alicia Alvarez, MD Gastroenterologist

Daylem Antunez, MD Gastroenterologist

Francisco J. Baigorri, MD Gastroenterologist

Simon Behar, MD Gastroenterologist

Gustavo Calleja, MD Gastroenterologist

Marc S. Carp, MD Gastroenterologist

C C11

CC1

CC3

CC1

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Lewis R. Felder, MD Gastroenterologist

Jose P. Ferrer Jr., MD Gastroenterologist

Jose P. Ferrer Sr., MD Gastroenterologist

Paul G. Fishbein, MD Gastroenterologist

Nelson Garcia Jr., MD Gastroenterologist

Pamela L. Garjian, MD Gastroenterologist

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CC3

C C18

CC3

C C16

Andres Gelrud, MD Gastroenterologist

Daniel Gelrud, MD Gastroenterologist

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C C1

Roberto Gonzalez, MD Gastroenterologist CC1

Pedro J. Greer Jr., MD Gastroenterologist

Guillermo Gubbins, MD Gastroenterologist

C C11

CC10

Alfredo J. Hernandez, MD Gastroenterologist CC11

Miami Dade County

Eugenio J. Hernandez, MD Gastroenterologist

Moises E. Hernandez, MD Gastroenterologist

Richard E. Hernandez, MD Gastroenterologist

Vicente Lago, MD Gastroenterologist

Robert C. Lanoff, MD Gastroenterologist

Jose A. Lavergne, MD Gastroenterologist

CC3

CC5

C C19

CC2

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Joanna Lopez, MD Gastroenterologist

Jerry Martel, MD, MPH Gastroenterologist

Flavia Mendes, MD Gastroenterologist

Pedro Morales, MD Gastroenterologist

CC1

CC8

CC1

CC8

James S. Leavitt, MD Gastroenterologist CC1

Marc Lederhandler, MD Gastroenterologist CC1

Brett R. Neustater, MD Gastroenterologist

Javier L. Parra, MD Gastroenterologist

Alfredo Rabassa, MD Gastroenterologist

Andres I. Roig, MD Gastroenterologist

Ricardo J. Roman, MD Gastroenterologist

Seth D. Rosen, MD Gastroenterologist

CC7

CC1

CC3

CC7

CC2

Neil E. Rosenkranz, MD Gastroenterologist

S. Lawrence Rothman, MD Gastroenterologist

Eduardo Ruan, MD Gastroenterologist

Andrew I. Sable, MD Gastroenterologist

George A. Sanchez, MD Gastroenterologist

Somal S. Shah, MD Gastroenterologist

CC2

CC1

CC2

CC1

C C11

Jason Slate, MD Gastroenterologist

Arie Slomianski, MD Gastroenterologist

Orlando Torres, MD Gastroenterologist

Stefania L. Vernace, MD Gastroenterologist

C C11

CC1

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Miami Dade County Colon and Rectal Surgeons

Luis Hernandez Colorectal Surgeon

Eduardo Krajewski, MD Colorectal Surgeon

Khristian Noto, MD Colorectal Surgeon

Rodolfo Pigalarga, MD Colorectal Surgeon

Marcos Szomstein, MD Colorectal Surgeon

CC9

Miami Dade County Pediatrics

Richard Arboleda, MD Pediatric Gastroenterologist

Roberto E. Gomara, MD Pediatric Gastroenterologist

C C26

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Erick Hernandez Pediatric Gastroenterologist

William I. Munios, MD Pediatric Gastroenterologist

Jesse Reeves-Garcia, MD Pediatric Gastroenterologist CC26

CC26

SUMMER 2017 ISSUE GASTRO MAGAZINE

Palm Beach County

Michael Blum, MD Gastroenterologist

James Chong, MD Gastroenterologist

CC 21

CC21

Jonathan Kaplan, MD Gastroenterologist

Morris Naus, MD Gastroenterologist

Leslie Perla MD, MPH Gastroenterologist CC20

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Palm Beach County Pediatrics

Enrique Hernandez-Sanchez, MD

Pediatric Gastroenterologist

Mariana Middelhof, MD Pediatric Gastroenterologist

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Alejandro Ramirez, MD Pediatric Gastroenterologist CC14

Jorge A. Rosario-Mulinelli, MD

Pediatric Gastroenterologist C C14

Anesthesia - Pathology - Radiology - Pharmacy

Kianfa Martinez, MD Anesthesiologist Kendall Endoscopy Center

Gabriel Rodriguez, MD Anesthesiologist Kendall Endoscopy Center

Curtis L. McCarty III, MD Medical Director Pathologist Pathology Lab

Raanan Sela Pathologist Pathology Lab

Steven Christie, MD Radiologist, Imaging Center

Allied Professionals

Pedro Gonzalez PA-C

Yusvell Gonzalez PA-C

Carol Hernandez PA-C

Jessica Jairala PA-C

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CC1

Sabrina Kaplan PA-C

Rebecca Karousatos,MS,RD,LDN Dietician/Nutritionist

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Allied Professionals

Ellen Matas-Sosa PA-C

Jose A. Miguel PA-C

Ricahrd Ornato PA-C

Ronal R. Ricano PA-C

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Darlene M Boytell-Perez

ARNP

Isel Gonzalez ARNP

Margaret Mathews-Dâ&#x20AC;&#x2122;Avanzo ARNP, DNP

Carolina Molina ARNP

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John Washington PA-C

Adalis Molina-Burset, PA-C

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Noe Tacoronte PA-C CC1

Yetzabel Rizo ARNP CC 1

Care Centers Care Center 1 Main Office 7500 SW 87 Avenue, Suite 200 Miami, FL 33173 305-913-0666

Care Center 7 Satellite Office #2 21110 Biscayne Blvd, Suite 206 Aventura, FL 33180 305-770-0062

Care Center 16 8353 SW 124 Street, Suite 108 Miami, FL 33156 305-669-1115

Care Center 2 9555 N. Kendall Drive, Suite 100 Miami, FL 33176 305-273-7319

Care Center 8 8200 SW 117 Avenue, Suite 110 Miami, FL 33183 305-274-5500

Care Center 18 8950 N. Kendall Drive, Suite 506W Miami, FL 33176 305-595-2710

Care Center 3 8950 N. Kendall Drive, Suite 306-W Miami, FL 33176 305-596-9966

Care Center 9 7765 SW 87 Avenue, Suite 212 Miami, FL 33173 305-596-3080

Care Center 19 351 NW 42nd Avenue, Suite 305 Miami, FL 33126 305-541-1041

Care Center 4 15955 SW 96 Street, Suite 307 Miami, FL 33196 305-468-4191

Care Center 10 475 Biltmore Way, Suite 207-A Coral Gables, FL 33134 305-662-6170

Care Center 20 1157 S State Road 7 Wellington, FL 33414 561-214-6695

Care Center 5 7765 SW 87 Avenue, Suite 105 Miami, FL 33173 305-274-0808

Care Center 11 3661 S. Miami Avenue, Suite 805 Miami, FL 33133 305-856-7333

Care Center 21 4675 Linton Boulevard, Suite 202 Delray Beach, FL 33445 561-495-4700

Care Center 6 1400 NE Miami Gardens Drive, Suite 221 North Miami Beach, FL 33179 305-949-2020

Care Center 13 9260 SW 72 Street, Suite 217 Miami, FL 33173 305-271-7330

Care Center 22 4791 West 4th Street Hialeah, FL 33012 305-825-0500

Care Center 7 Main Office 16855 NE 2nd Avenue, Suite 202 North Miami Beach, FL 33162 305-770-0062

Care Center 14 9980 Central Park Blvd N., Suite 316 Boca Raton, FL 33428 561-206-6064

Care Center 23 10167 NW 31st Street, Suite 201 Coral Springs, FL 33065 954-755-3374

Care Center 7 Satellite Office #1 5803 NW 151 Street, Suite 105 Miami Lakes, FL 33014 305-770-0062

Care Center 15 8353 SW 124 Street, Suite 203 Miami, FL 33156 305-259-8720

Care Center 24 4700 Sheridan Street, Suite F Hollywood, FL 33021 954-961-8400

11011 Sheridan Street, Suite 109 Cooper City, FL 33026 954-431-7724

Insurances

Care Center 25, Main Office 7152 Coca Sabal Lane Fort Myers, FL 33908 239-939-9939

AARP Medicare Complete Aetna AvMed Beech Street Blue Cross Blue Shield Care Plus (Colorectal Only) Cigna Coventry Health Care Dimensions Healthcare First Health Network Healthease of Florida (Peds Only) HealthSun Health Plans Humana Leon Medical Center (Colorectal Only) Magellan Healthcare (Peds Only) Mail Handlers Benefit Plans Medica Health Plan Medicare Part B Memorial Health Network Molina Healthcare (Peds Only) MultiPlan Neighborhood Health Plan Preferred Care Partners Prestige Health Choice (Peds Only) Simply Healthcare Sunshine Health (Peds Only) Tricare United Healthcare Web TPA Wellcare

Care Center 25, Satellite Office 9400 Gladiolus Drive, Suite 250 Fort Myers, FL 33908 239-939-9939 Care Center 26, Main Office 3200 SW 60th Court, Suite 204 Miami, FL 33155 305-661-0037 Care Center 26, Satellite Office 8955 SW 87th Court, Suite 206 Miami, FL 33176 786-888-2480 Imaging Center 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4190 Pathology Laboratory 12485 SW 137 Avenue, Suite 103 Miami, FL 33186 305-468-4194 Specialty Pharmacy 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4199

Only accepted at our Pediatric Care Centers

Cleansing for Colonoscopies

Just Got Easier

ccording to the American Cancer Society, colorectal cancer is the second most common cancer in both men and women in the United States. In fact, colon cancer causes 50,000 deaths each year. However, at least 60% of these deaths could be prevented if every adult received proper screening.

SUMMER 2017 ISSUE GASTRO MAGAZINE

Traditionally, patients who are scheduled for a colonoscopy will be asked to go on a liquid diet 1-3 days prior to the test. They may be asked to drink a laxative powder or take a pill to cleanse their bowels, which causes diarrhea, making it an uncomfortable process that can impact their daily activities. Gastro Health knows that being able to conduct same day prep can help avoid these discomforts. It can also encourage people who have avoided colonoscopies in the past because they did not want to undergo the traditional preparations for this life-saving procedure. Fortunately, Gastro Health is now offering the HyGleaCare® prep to prepare patients for colonoscopies at their HyGIeaCare Center. This new office will be adjacent to the Gastro Health Endoscopy Center at 7800 S.W. 87th Avenue in Miami, Florida. HyGleaCare will replace conventional preps and effectively cleanses the bowel using a gentle infusion of warm, gravity-flow filtered water. This means patients may forgo many of the elements that make traditional bowel prep inconvenient and uncomfortable, and can now experience simple, easy bowel prep for their scheduled colonoscopy. “A good bowel prep is the first step in a colonoscopy screening that can detect potential cancer risks and prevent colon cancer,” added Dr. James Leavitt, President/ Co-Founder of Gastro Health. “This is why we have partnered with HyGIeaCare to prep our patients. Our patients will now be able to prepare comfortably for their colonoscopy in a safe, private and hygienic environment at the HyGIeaCare Center - without a sleepless night and without having to repeatedly run to the bathroom”. “Our team is excited about the opportunity to prep patients for colonoscopies at the new HyGIeaCare Center that we have established together with Gastro Health in Miami,” said Gavriel Meron, Chairman and CEO of HyGIeaCare, Inc.

HOW IT WORKS At the Gastro Health HyGIeaCare Center, the prep will be performed in a clean and comfortable environment. A trained tech will lead the patient to a private room where he or she is seated on an ergonomic basin. The tech walks the patient through the procedure, which routinely takes less than one hour. A small, sterile, disposable nozzle is lubricated and inserted about an inch into the rectum and a gentle stream of warm water flows into the bowel, loosening stool and causing the intestines to contract allowing for the comfortable, odorless and discreet evacuation of the colon. Water continues to gently flow until the tech determines the colon has been sufficiently cleansed. The HyGIeaCare Prep replaces traditional preparation for colonoscopy screening and is performed on the same day as the procedure. It is safe, simple, comfortable and preferred over the oral preparation process. For more information on the HyGleaCare prep available for Gastro Health patients, visit www.hygieacare.com

Risk Factors for Colon Cancer Current guidelines from the U.S. Preventive Services Task Force state people age 50 and older with average risk factors should receive an initial colonoscopy followed by additional colonoscopies every 10 years or more, depending on the findings from the initial screening. Patients who are considered high risk for colon cancer should talk to a doctor to determine if they may need to be screened earlier than age 50. Certain factors can increase your risk for colon cancer including: • Being age 50 or older • A family history of colon and rectal cancer • History of ulcerative colitis or Crohn’s Disease • Smoking • Obesity • Physical inactivity

BY Mariana S. J. Middelhof, MD Pediatric Gastroenterologist

SUMMER 2017 ISSUE GASTRO MAGAZINE

Relieving Constipation in Children

onstipation is generally understood as difficulty or reduced frequency in defecation. It is fairly common in children, affecting up to 30% of the population under 18. In most pediatric cases, constipation can begin when there are changes in the diet or routine, during toilet training, or after an illness. There are two kinds of constipation in children–organic or functional. Organic means there is an identifiable cause. Fortunately, more than 95% of cases in healthy children one year or older is functional, meaning that while constipation may be an issue, there is usually no worrisome cause behind it. Functional constipation, in children age 4 and up is defined by the presence of at least two of the following symptoms occurring at least once per week, for at least one month and that are not explained by another medical condition: • Two or fewer defecations per week • At least one episode of fecal incontinence per week • History of retentive posturing or excessive volitional stool retention (stool withholding) • History of painful or hard bowel

movements • Presence of a large fecal mass in the rectum • History of large-diameter stools that may obstruct the toilet The peak prevalence of constipation is typically during the preschool years. Although constipation is common, it is important to evaluate affected children to identify potential organic causes of constipation. If an organic cause cannot be addressed, then studies show that children benefit from prompt and thorough treatment interventions, typically within 3 months of the onset of symptoms. Tardy or scanty intervention may result in stool-withholding behavior with worsening constipation and psychosocial consequences. Common organic causes of constipation include cow’s milk or other dietary protein intolerance, celiac disease and hypothyroidism. Other rare but urgent causes can be Hirschsprung’s disease, spinal dysraphism, sacral teratoma, infantile botulism, Cystic fibrosis, lead poisoning or intestinal obstruction. Treatment of constipation differs according

to the cause of the problem. Some children may only require changes in diet such as an increase in fiber, fresh fruits, or in the amount of water they drink each day. Other patients may require medications such as stool softeners or laxatives. A few children may require a bowel clean-out to help empty the colon of the large amount of stool. It is often useful to start a bowel training routine where the child sits on the toilet for five to ten minutes after every meal in order to encourage good behavior habits. If you feel your child is dealing with constipation, don’t hesitate to request an evaluation from a pediatric gastroenterologist. Dr. Mariana S.J. Middelhof is a boardcertified pediatric gastroenterologist with Gastro Health and sees patients in our Wellington office located at 1157 State Road 7, Wellington, Florida 33414.

At Gastro Health Pediatrics, our biggest priority is taking care of your little ones.

Gastro Health, South Floridaâ&#x20AC;&#x2122;s largest gastroenterology medical group, offers exceptional pediatric care in both Miami-Dade and Broward Counties. We treat all gastro conditions in children of every age, and we support them with the convenience of our own infusion and imaging. At Gastro Health Pediatrics, we deliver world-class care right where you need itâ&#x20AC;&#x201C;close to home.

Find a location near you: 9980 NW Central Park Blvd. North, Suite 316 Boca Raton, FL 33428 561-206-6064 Providers Enrique Hernandez-Sanchez, MD Jorge Rosario-Mulinelli, MD Alejandro Ramirez, MD

3200 SW 60th Court, Suite 204 Miami, FL 33155 305-661-0037

8955 SW 87th Court, Suite 206 Miami, FL 33176 786-888-2480

Providers Richard Arboleda, MD | Jesse Reeves-Garcia, MD Roberto Gomara, MD | William Muinos, MD Erick Hernandez, MD

1157 South State Road 7 Wellington, FL 33414 561-214-6695 Providers Enrique Hernandez-Sanchez, MD Mariana S. J. Middelhof, MD

www.GastroHealth.com

backyard barbecue.

SUMMER 2017 ISSUE GASTRO MAGAZINE

lunch date.

If other treatments haven’t worked well enough, ask your gastroenterologist about ENTYVIO.® Uses of ENTYVIO® (vedolizumab): ENTYVIO is a prescription medicine used in adults: • With moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider. • With moderate to severe Crohn’s disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.

Important Safety Information about ENTYVIO® • Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients. • ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you

have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash; itching; swelling of your lips, tongue, throat or face; shortness of breath or trouble breathing; wheezing; dizziness; feeling hot; or palpitations (feel like your heart is racing). • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms:

ENTYVIO is a trademark of Millennium Pharmaceuticals, Inc., registered with the U.S. Patent and Trademark Office, and is used under license by Takeda Pharmaceuticals America, Inc.

Printed in U.S.A./January 2017 USD/VED/15/0279(1)a

outdoor concert.

MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN’S SYMPTOMS LEAVING YOU WITH THE SAME VIEW? It may be time for a different perspective.

• DEVELOPED ONLY FOR UC AND CROHN’S • GI-FOCUSED • PROVEN TO PROVIDE RELIEF AND REMISSION Individual results may vary.

confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice). • The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, ﬂu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.

with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed. Please see the Medication Guide for ENTYVIO on the adjacent page and talk with your healthcare provider. 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.

• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone

Learn more at ENTYVIO.com

Relief and Remission within reach.

SUMMER 2017 ISSUE GASTRO MAGAZINE

Medication Guide ENTYVIO (en ti' vee oh) (vedolizumab) What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). • Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver Problems. Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice). See “What are the possible side effects of ENTYVIO?” for more information about side effects. What is ENTYVIO? ENTYVIO is a prescription medicine used in adults: • with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get UC under control (induce remission) and keep UC under control (maintain remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines ° to improve the way the lining of your large intestine looks to your healthcare provider during colonoscopy • with moderate to severe active Crohn’s disease when certain other Crohn’s disease medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get Crohn’s disease under control (achieve remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines It is not known if ENTYVIO is safe and effective in children under 18 years of age. Who should not receive ENTYVIO? Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO. See the end of this Medication Guide for a complete list of ingredients in ENTYVIO.

Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: • have an infection, think you may have an infection or have infections that keep coming back (see “What is the most important information I should know about ENTYVIO?”). • have liver problems • have tuberculosis (TB) or have been in close contact with someone with TB. • have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO. • are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO. • are breastfeeding or plan to breastfeed. It is not known if ENTYVIO passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine. How will I receive ENTYVIO? • ENTYVIO is given through a needle placed in a vein (intravenous infusion) in your arm. • ENTYVIO is given to you over a period of about 30 minutes. • Your healthcare provider will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment. What are the possible side effects of ENTYVIO? ENTYVIO may cause serious side effects, See “What is the most important information I should know about ENTYVIO?” The most common side effects of ENTYVIO include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all of the possible side effects of ENTYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about ENTYVIO Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about ENTYVIO that is written for health professionals. Do not use ENTYVIO for a condition for which it was not prescribed. What are the ingredients in ENTYVIO? Active ingredient: vedolizumab Inactive ingredients: L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose and polysorbate 80 Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015 U.S. License No. 1898 For more information, go to www.ENTYVIO.com or call 1-877-825-3327 This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: May 2014 ENTYVIO is a trademark of Millennium Pharmaceuticals Inc. and is used under license by Takeda Pharmaceuticals America, Inc. All other trademark names are the property of their respective owners. ©2014 Takeda Pharmaceuticals America, Inc. VMB245 R1_CFBS L-BZV-0514-4

Cut your appetite down to size Gastro Health introduces Balloongi, a NEW weight loss program designed to help you reach a healthier weight. Balloongi is a non-surgical, non-invasive gastric balloon that is FDA-approved and has proven results. It’s designed to provide effective, motivating results along with the insight you need to establish healthy behaviors and keep the weight off. Gastro Health will be hosting FREE informative sessions to explain the full program. It’s time to cut your appetite and your weight down to size with Balloongi.

*Gastro Health’s Balloongi program is not covered by commercial or governmental insurance programs. Copyright @2017 Gastro Health, LLC all rights reserved. This publication is published by Gastro Health, LLC which is solely responsible for its contents. This information presented is intended only for residents of the United States. The material presented is intended only as informational, or as an educational aid, and is not intended to be taken as medical advice. The ultimate responsibility for a patients care resides with a healthcare professional.

For more information visit us at balloongi.com or call us for an appointment at 786.650.3156

Gastro Health Growth

SUMMER 2017 ISSUE GASTRO MAGAZINE

Provides Patients Expert Care and Convenience

n 2017, Gastro Health became South Florida’s largest gastroenterology provider with over 90 physicians at 26 locations. The company’s rapid and expansive growth provides patients with more opportunities to access expert GI physicians close to home. This year, Gastro Health branched outside of Miami-Dade with locations in Wellington, Delray Beach, Coral Springs, Hollywood and Cooper City while also adding additional locations in Hialeah and Kendall. In addition, Gastro Health is now on the west coast of Florida with two locations in Fort Myers. The group also plans to add more practices throughout Florida with acquisitions in Orlando, West Palm Beach and Naples. “We are also looking to move out of Florida, as well, and are in discussions with groups in Texas, Indianapolis, Pennsylvania and Michigan,” said Alejandro Fernandez, Gastro Health CEO. “Our goal is to be a premier national GI group that provides a full continuum of digestive care with adult and pediatric gastroenterologists, colorectal surgeons and imaging and infusion centers.” In addition to expanding locations, Gastro Health also actively recruits physicians from around the country who are experts in the field of gastroenterology to come and practice in Florida. In fact, a report by the Safety Net Hospital Alliance of Florida and the Teaching Hospital Council of Florida predicts a statewide shortage of doctors by the year 2025 in key specialties like psychiatry, surgery and gastroenterology.

“By recruiting top physicians to Gastro Health, not only are we providing our patients with access to experts who are constantly evolving the way GI care is delivered, but we are also addressing Florida’s physician shortage,” said Fernandez. Gastro Health was founded in 2006 and provides patients access to some of the nation’s premier gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. In addition to delivering gastrointestinal care, providers offer a wide range of additional services including: anesthesia, infusion, imaging, pathology, specialty pharmacy and in-office RX dispensing.

Gastro Health takes pride in providing outstanding medical care and an exceptional healthcare experience for patients.

THRIVE

IN A COMPETITIVE ENVIRONMENT

Miami Division: 305-714-4400 Direct Inquires to Neil Verdeja at nverdeja@bbmia.com or Luis QuiÃ±ones at lquinones@bbmia.com

www.bbmia.com

Colon Cancer by the Numbers

SUMMER 2017 ISSUE GASTRO MAGAZINE

The earlier that colon cancer is detected, the greater the chances of survival. Here is what you need to know about colon cancer:

Don't Let

COLON CANCER

Take You From The Ones You Love

Be there for your family during those special moments. Your health matters. Early detection can save your life.

Itâ&#x20AC;&#x2122;s time to FAST TRACK your colonoscopy today! Call 877.223.8012 to schedule your appointment.

www.FastTrackColonoscopy.com Copyright @2017 Gastro Health, LLC all rights reserved. This publication is published by Gastro Health, LLC which is solely responsible for its contents. This information presented is intended only for residents of the United States. The material presented is intended only as informational, or as an educational aid, and is not intended to be taken as medical advice. The ultimate responsibility for a patients care resides with a healthcare professional.

SUMMER 2017 ISSUE GASTRO MAGAZINE

TOGETHER WE CAN BEAT CROHN’S The right support makes a difference. That’s why for over a decade, at UCB, Inc. we have been supporting the Crohn’s community online at CrohnsandMe.com. You can find tips, recipes, stories from others in the community, and educational info about the disease. Visit CrohnsandMe.com or our Crohn’s and Me Facebook page to learn more!