Please see full Prescribing Information, including boxed warning and Medication Guide, on pages Your Treatment.

Transcription

1 Please see full Prescribing Information, including boxed warning and Medication Guide, on pages Your Treatment Our Commitment

2 CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON Important Safety Information This summary contains important information about Ribasphere (Rīb-ă-sphere) (ribavirin, USP) tablets. It is not meant to take the place of your doctor s and/or healthcare provider s instructions. Read this information carefully before you start taking Ribasphere. Ask your doctor and/or healthcare provider if you do not understand any of this information, or if you want to know more about Ribasphere. Read the Medication Guide given to you for Ribasphere. Also read the Medication Guide for PEGASYS 1 (peginterferon alfa-2a). WARNING: RISK OF SERIOUS DISORDERS AND RIBASPHERE ASSOCIATED EFFECTS See full Prescribing Information for complete boxed warning You should not take Ribasphere alone to treat chronic hepatitis C infection. Ribasphere may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. People with a history of serious heart disease should not be treated with this medicine. Please talk to your health care professional to see if this medicine is right for you. Ribasphere may cause birth defects or death of your unborn baby. You should not take Ribasphere if you are pregnant or your sexual partner is pregnant, nor should you or your partner become pregnant while you are taking Ribasphere and for 6 months after you stop treatment. You need to use two forms of reliable birth control when you take Ribasphere and for the 6 months after treatment. MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

3 CONGRATULATIONS ON DECIDING TO BEGIN TREATMENT FOR YOUR HEPATITIS C CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK By starting treatment, you have made an important step towards potentially curing your hepatitis C (hep C). You may have many questions about treatment. Included in this booklet is some useful information that may help answer your questions and give you a sense of what to expect. In addition, you may learn ways to make it easier to stick to therapy. Remember, the most important resource available to you is your healthcare provider. Think of him/her as your treatment partner. You both share the same goal of successfully treating your hep C. Please be sure to discuss any questions about hep C with your healthcare provider. What is hep C? Hep C is a disease caused by a virus that attacks the liver and is spread through blood-to-blood contact. Hep C often shows no symptoms and may often go undetected for years. If left untreated, hep C may lead to liver scarring, severe liver damage and even liver cancer. Hep C treatment Chronic hep C treatment duration will vary based on many factors including the patient s genotype. The goal of any hep C treatment is to reach a sustained virologic response (SVR). This is what healthcare providers refer to as curing hep C. SVR means that the hep C virus can not be found in your body 24 weeks after treatment. DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C Important Safety Information (cont d) What is Ribasphere? Ribasphere (ribavirin, USP) tablets are used in combination with another medicine called peginterferon alfa-2a to treat chronic (lasting a long time) hepatitis C infection (CHC) in people 5 years and older whose livers still work normally, and who have not been treated before with a medicine called an interferon alpha. This combination is also used to treat CHC patients coinfected with human immunodeficiency virus (HIV). It is not known if Ribasphere is safe and will work in children under 5 years of age. Who should not take Ribasphere? Do not take Ribasphere if you: have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis); have certain blood disorders, such as thalassemia major or sickle-cell anemia (hemoglobinopathies); have severe kidney disease; or take didanosine (Videx 2 or Videx EC 2 ). RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

4 What is Ribasphere RibaPak? Ribasphere RibaPak s daily 2-pill regimen and convenient blister packaging provide easier dosing Should be taken with food. Always just 2 ribavirin pills per day no matter the daily dose Clearly marked for AM/PM dosing Allows you to easily recognize missed doses CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED Ribasphere RibaPak is a prescription medicine called ribavirin. This ribavirin medicine is used in combination with another medicine called peginterferon alfa-2a to treat chronic (lasting a long time) hepatitis C infection (CHC) in people 5 years and older whose livers still work normally, and who have not been treated before with a medicine called an interferon alpha. This combination is also used to treat adult CHC patients coinfected with human immunodeficiency virus (HIV). 5 Monthly CoPay as low as $ Eligibility: Insured and Cash Patients BILL PRIMARY INSURANCE FIRST RxBIN: RxPCN: RxGrp: RxID: Suf: OHCP OHXXXXXXX Eligible patients may save up to $150 toward each monthly Ribasphere RibaPak copay for up to 18 fills. Valid for all self-pay patients and most patients with commercial insurance. There are ways you can save money on your medication, go to page 12 to find out more. YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD Important Safety Information (cont d) Important information about Ribasphere: 1. You should not take Ribasphere alone to treat chronic hepatitis C infection. Ribasphere should be used in combination with peginterferon alfa-2a to treat chronic hepatitis C infection. 2. Ribasphere may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. Tell your healthcare provider if you have ever had any heart problems. Ribasphere may not be right for you. If you have chest pain while you take Ribasphere, seek emergency medical attention right away. 3. Ribasphere may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, do not take Ribasphere. You or your sexual partner should not become pregnant while you take Ribasphere and for 6 months after treatment is over. You must use two forms of birth control when you take Ribasphere and for the 6 months after treatment. Females must have a pregnancy test before starting Ribasphere, every month while treated with Ribasphere, and every month for the 6 months after treatment with Ribasphere. TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

5 How should I take Ribasphere RibaPak? It is important to take all of your Ribasphere RibaPak Tablets. Always follow your healthcare provider s instructions on how to take your medicines. Take 2 Ribasphere RibaPak Tablets each day: 1 tablet in the morning (AM) and 1 tablet in the evening (PM) Take Ribasphere RibaPak Tablets with food. Finishing your 7-day pack may remind you to give yourself your peginterferon injection. If you take too much Ribasphere RibaPak, call your healthcare provider or local Poison Control Center right away, or go to the nearest hospital emergency room right away. Your healthcare provider should do blood tests before you start treatment with Ribasphere RibaPak, at weeks 2 and 4 of treatment, and then as needed to see how well you are tolerating treatment and to check for side effects. Your healthcare provider may change your dose of Ribasphere RibaPak based on blood test results or side effects you may have. If you have heart problems, your healthcare provider should check your heart by doing an electrocardiogram before you start treatment with Ribasphere RibaPak, and if needed during treatment. What should I avoid while taking Ribasphere RibaPak? Ribasphere RibaPak can make you feel dizzy, tired, or confused. You should not drive or operate machinery if you have any of these symptoms. Do not drink alcohol, including beer, wine and liquor. This may make your liver disease worse. What if I miss a dose? If you miss a dose of Ribasphere RibaPak, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider. CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C Important Safety Information (cont d) If you or your female sexual partner becomes pregnant while taking Ribasphere or within 6 months after you stop taking Ribasphere, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes Ribasphere while she is pregnant. What are the possible side effects of Ribasphere? Ribasphere can cause serious side effects including: swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting or diarrhea; severe allergic reactions: Symptoms may include hives, wheezing, trouble breathing, chest pain, swelling of your mouth, tongue, or lips, or severe rash; RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

6 Getting started It is important to take your Ribasphere RibaPak as instructed by your healthcare provider, and for the entire course of treatment. Do not change your daily dose or stop taking Ribasphere RibaPak without first talking with your healthcare provider. Remember, Ribasphere RibaPak is used in combination with another medicine, called peginterferon alfa-2a. Your healthcare provider will determine the correct daily dose of Ribasphere RibaPak: How do I open my Ribasphere RibaPak? Ribasphere RibaPak Tablets are packaged in 7-day (weekly) sleeves. Please follow the instructions below to open this packaging. 1. Using your right thumb, push down on [1] 2. While pressing down on [1], pull on tab [2] with your left thumb and forefinger 3. Pull out the blister card of Ribasphere RibaPak tablets to your left 4. Remove 1 tablet 5. Fold the blister card and slide it to the right to close the pack CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING Don t like to take medication? You re not alone. With Ribasphere RibaPak you take just 2 ribavirin pills with food each day. TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT Important Safety Information (cont d) serious breathing problems: Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death; serious eye problems: Which could lead to vision loss or blindness; liver problems: Some people may get worsening of liver function. Tell your healthcare provider right away if you have any of these symptoms: stomach bloating, confusion, brown urine and yellow eyes; FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

7 Partnering with your healthcare provider You re not on this journey alone. Your healthcare provider plays a big role in the success of your treatment. Remember, the more you communicate, the more your healthcare provider can support you. Questions your healthcare provider may ask you about Lifestyle: Are you drinking alcohol or using recreational drugs? Are you smoking cigarettes? Are you exercising? What are your dietary habits? Emotional/physical state: Are you or your partner pregnant or planning to become pregnant? Are you feeling stressed? Have you ever been diagnosed with depression? Are you feeling angry or upset? Are you currently getting psychiatric help? Are you feeling tired? Have you ever been diagnosed with heart disease? Are you having trouble sleeping? Your treatment: Have you missed any doses of your medication? Are you feeling any symptoms or side effects? Important Safety Information (cont d) severe depression; suicidal thoughts and attempts; and/or effect on growth in children. Children can experience a delay in weight gain and height increase while being treated with peginterferon alfa-2a and Ribasphere. Catch-up in growth happens after treatment stops, but some Questions to ask your healthcare provider about Treatment: Are there any foods I should eat or avoid during treatment? What are the possible risks of treatment? What is my viral load (the amount of hep C virus in your blood)? What are my options if treatment doesn t work? Are there ways I can improve the results of my treatment? What is the most important safety information I should know about Ribasphere RibaPak? What are some ways to manage side effects that may occur with treatment? Other medications/conditions: Are there prescription and over-the-counter medications I should avoid? Are there herbal products or supplements I should avoid? Should I worry about my other medical conditions during treatment? Relationships: Should people I m close to be tested for hep C? How can I protect the people around me from hep C? What types of contraception should my partner and I use while I am on treatment? Support: Can I receive financial help for my treatment? What resources are there to help me better understand hep C and treatment? children may not reach the height that they were expected to have before treatment. Talk to your healthcare provider if you are concerned about your child s growth during treatment with peginterferon alfa-2a and Ribasphere. CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

8 Tips to help you remember to take your medications Taking your medications as prescribed may help improve your chances of treating your hep C. Here are some tips that may help you remember to take your medications. Make it part of your daily routine Take your medicines at the same time(s) every day, each week. Keep your medications organized and in a location you ll remember. Make notes of when you take your medicine each day, so you can see how you are sticking to your regimen. Set up reminders Electronic reminders, like cell phone texts or alarms, are great ways to help you remember your next dose. If you are comfortable doing so, leave notes around the house where you will be sure to see them on the refrigerator, next to the TV and/or on the bathroom mirror. Be prepared when traveling Your schedule may change while you re away so be sure to bring an extra supply of medication. Plan ahead Refill your prescriptions in advance. Learn about the reimbursement and copay assistance programs offered by the makers of your hep C medications. Be sure to keep all your appointments. Ask family and friends for help If you have family members or friends who know about your condition, have them remind you to take your medication. It can be encouraging to have support from someone close to you. CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING Important Safety Information (cont d) Call your healthcare provider or get medical help right away if you have any of the symptoms listed above. These may be signs of a serious side effect of Ribasphere treatment. Common side effects of Ribasphere used in combination with peginterferon alfa-2a include: flu-like symptoms (for example: feeling tired, headache, shaking along with high temperature (fever), and muscle or joint aches); mood changes, feeling irritable, anxiety and difficulty sleeping; loss of appetite, nausea, vomiting and diarrhea; hair loss; and/or itching. Before you take Ribasphere, tell your healthcare provider if you are, have, or have had: treatment for hepatitis C that did not work for you; serious allergic reactions to Ribasphere, or to any of the ingredients in Ribasphere; breathing problems (Ribasphere may cause or worsen your breathing problems you already have.); vision problems (Ribasphere may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with Ribasphere.); certain blood disorders such as anemia; high blood pressure, heart problems or have had a heart attack (Your healthcare provider should test your blood and heart before you start treatment with Ribasphere.); thyroid problems; diabetes (Ribasphere and peginterferon alfa-2a combination therapy may make your diabetes worse or harder to treat.); liver problems other than hepatitis C virus infection; human immunodeficiency virus (HIV) or other immunity problems; mental health problems, including depression or thoughts of suicide; kidney problems; TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

9 What are the serious side effects of Ribasphere RibaPak? swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting or diarrhea; severe allergic reactions: Symptoms may include hives, wheezing, trouble breathing, chest pain, swelling of your mouth, tongue, or lips, or severe rash; serious breathing problems: Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death; serious eye problems: Which could lead to vision loss or blindness; liver problems: Some people may get worsening of liver function. Tell your healthcare provider right away if you have any of these symptoms: stomach bloating, confusion, brown urine and yellow eyes; severe depression; suicidal thoughts and attempts; and/or effect on growth in children. Children can experience a delay in weight gain and height increase while being treated with peginterferon alfa-2a and Ribasphere RibaPak. Catch-up in growth happens after treatment stops, but some children may not reach the height that they were expected to have before treatment. Talk to your healthcare provider if you are concerned about your child s growth during treatment with peginterferon alfa-2a and Ribasphere RibaPak. Call your healthcare provider or get medical help right away if you have any of the symptoms listed above. These may be signs of a serious side effect of Ribasphere RibaPak treatment. What are the common side effects of Ribasphere RibaPak? Common side effects of Ribasphere RibaPak used in combination with peginterferon alfa-2a include: flu-like symptoms (for example: feeling tired, headache, shaking along with high temperature (fever), and muscle or joint aches); mood changes, feeling irritable, anxiety and difficulty sleeping; loss of appetite, nausea, vomiting and diarrhea; hair loss; and/or itching. These are not all the possible side effects with Ribasphere RibaPak. For a complete list of side effects, please see the accompanying full Prescribing Information and Medication Guide. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA You may also report negative side effects to Kadmon Pharmaceuticals, LLC at CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

10 Managing side effects You may experience side effects while taking Ribasphere RibaPak. Always tell your healthcare provider about side effects because he/she may be able to help. Side effects may also be sign of a more serious condition. Below are some side effects you may experience during treatment and some ways you might help manage them. Remember, always discuss your side effects with your healthcare provider before changing your routine. Fatigue Do some low-impact aerobic exercise, like walking or swimming. Take short naps. Modify your work schedule. Nausea/flu-like symptoms Always take your ribavirin with food, as directed in the Medication Guide. Eat several small meals per day instead of 3 large ones. Maintain a healthy diet. Rash/skin reactions Drink lots of water to help you stay hydrated. Apply lotion after bathing to reduce dry skin. Avoid too much sun and use a sunscreen with an SPF of 30 or higher. Important Safety Information (cont d) an organ transplant; drug addiction or abuse; infection with the hepatitis B virus; breast feeding (It is not known if Ribasphere passes into your breast milk. You and your healthcare provider should decide if you will take Ribasphere or breast-feed.); and/or any other medical condition. Avoid tanning beds and booths. Soak in an oatmeal bath. Talk with your healthcare provider about taking an antihistamine or other treatments. Insomnia Avoid reading or watching TV in bed. Try to go to bed at the same time each night. Avoid exercise or difficult activity before bed. Avoid caffeine before bed. Talk with your healthcare provider about sleep aids. Light-headedness After lying down, sit up slowly and remain sitting for 1 to 2 minutes before standing. Avoid things that can adversely affect circulation, like tobacco. Drink plenty of water or other fluids to avoid dehydration. Anemia A serious side effect of Ribasphere RibaPak is anemia, which is a blood condition that lowers the number of red blood cells in the body. Talk to your healthcare provider about ways to help manage anemia. If you feel chest pain or shortness of breath while taking Ribasphere RibaPak, get emergency medical attention right away. How should you take Ribasphere? Take Ribasphere exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Ribasphere to take and when to take it. For children 5 years of age and older your healthcare provider will prescribe the dose of Ribasphere based on weight. Take Ribasphere with food. CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

11 HEP C TREATMENT PLEDGE Taking medication isn t always easy, but your commitment counts. It s your dedication to stick to your treatment plan that will make all the difference. Here is a pledge you can make to help you reach your goal. I understand that taking all my medications as prescribed may increase my chances of curing hep C; I am committed to taking all my medications during my entire course of treatment; I have read and understand the risks related to treatment in the side effects section of this booklet, and have discussed them with my healthcare provider; I know that my healthcare provider is here to help manage any side effects I may have; I understand the risks associated with pregnancy during treatment, outlined on the Ribavirin Pregnancy Registry website. I understand that two (2) forms of birth control must be used when taking Ribasphere RibaPak and for six (6) months after treatment; and I will work together with my healthcare provider to reach my treatment goals. I PLEDGE TO DO MY BEST TO SUCCESSFULLY TREAT HEP C. Patient signature Healthcare provider name Healthcare provider phone number Date Your medication information: Ribasphere RibaPak (ribavirin, USP) Tablets: mg AM mg PM Pegasys (peginterferon alfa-2a): 1 injection/week CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

12 Save money with the $5 Ribasphere RibaPak CoPay Savings Card Majority of eligible patients pay $5 for Ribasphere RibaPak CONTENTS Visit to download a $5 CoPay Savings Card for immediate use. Eligible patients pay as little as $5 per month Savings up to $150 per monthly prescription You may pay less than generic ribavirin Eligible patients may save up to $150 toward each monthly Ribasphere RibaPak copay for up to 18 fills. The Ribasphere RibaPak CoPay Savings Card is available for self-pay patients and most commercially insured patients except those residing in Massachusetts and Puerto Rico. Patients covered by Medicare, Medicaid, TRICARE or other federal or state healthcare programs are not eligible. Patients must be 5 years of age or older to participate. A parent or legal guardian must enroll on behalf of patients under 18 years of age. The CoPay Savings Card is valid for Ribasphere RibaPak product only. Only one (1) CoPay Savings Card is required per patient. If denied copay card savings, patients may be eligible to receive a discount directly from Opus Health through its Mail-in Rebate Program by calling the phone number provided on the card. Monthly CoPay as 5low as $ Eligibility: Insured and Cash Patients BILL PRIMARY INSURANCE FIRST RxBIN: RxPCN: RxGrp: RxID: Suf: OHCP OHXXXXXXX Eligible patients may save up to $150 toward each monthly Ribasphere RibaPak copay for up to 18 fills. Valid for all self-pay patients and most patients with commercial insurance. INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD Important Safety Information (cont d) If you miss a dose of Ribasphere, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider. If you take too much Ribasphere, call your healthcare provider or local Poison Control Center right away, or go to the nearest hospital emergency room right away. Your healthcare provider should do blood tests before you start treatment with Ribasphere, at weeks 2 and 4 of treatment, and then as needed to see how well you are tolerating treatment and to check for side effects. Your healthcare provider may change your dose of Ribasphere based on blood test results or side effects you may have. If you have heart problems, your healthcare provider should check your heart by doing an electrocardiogram before you start treatment with Ribasphere, and if needed during treatment. What should you avoid while taking Ribasphere? Ribasphere can make you feel tired, dizzy or confused. You should not drive or operate machinery if you have any of these symptoms. Do not drink alcohol, including beer, wine and liquor. This may make your liver disease worse. TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

13 Talking with friends and family about hep C Let s be honest, talking with family and friends about your hep C can be difficult. You may feel like pulling away from people you care about rather than risk them knowing. However, if you re open and honest with those close to you, they may be able to support and encourage you throughout your treatment. Who should you tell? Of course it s up to you to decide who to tell about your hep C. If you re not sure, you may want to consider telling your family, your spouse or your sexual partners. Family or friends may react with concern when they hear the news. They may be worried about your health, as well as their own. It can be helpful if you understand some of their concerns and questions upfront so that you re ready to answer them. To make the conversation easier, do some preparation before you sit down to talk. Here are a few tips on what to discuss when you tell your family or friends about your hep C. Hep C typically progresses slowly and may not cause symptoms for many years, if ever. However, if left untreated, hep C can lead to significant liver damage and even liver cancer. Hep C is typically a manageable disease and treatment may cure it. Hep C is spread through blood-to-blood contact, not through casual contact, like kissing, hugging or shaking hands. It s difficult to pass hep C onto someone else, so the risk of giving it to a family member is very low. Never share needles, syringes, toothbrushes, razors or any other item that can have even a speck of your blood on it. CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C Important Safety Information (cont d) Medicine interactions: Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some medicines can cause serious side effects if taken while you also take Ribasphere. Some medicines may affect how Ribasphere works or Ribasphere may affect how your other medicines work. Especially tell your healthcare provider if you take any medicines to treat HIV, including didanosine (Videx 2 or Videx EC 2 ), or if you take azathioprine (Imuran 3 or Azasan 4 ). RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION Please see full Prescribing Information, including boxed warning and Medication Guide, on pages

14 CONTENTS INTRODUCTION ABOUT RIBASPHERE RIBAPAK Resources and support groups No one knows more about what you re feeling than another person with hep C, so we encourage you to communicate with others who are on treatment now or have been through it in the past. Speaking with people who understand what you re going through can be very helpful. Here is a list of some resources and support groups that you may find helpful.* Centers for Disease Control and Prevention CDC-INFO ( ) Provides facts about hep C and treatment HCV Advocate Provides unbiased information, support and advocacy to all communities affected by hep C and HIV/hep C coinfection Important Safety Information (cont d) Talk to your healthcare provider before starting treatment with Ribasphere if you have any of these medical conditions. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see Ribasphere full Prescribing Information and Medication Guide, including boxed warning, for additional Important Safety Information. Visit or call HELP-4-HEP HELP-4-HEP or Offers support at any stage of hep C care, from answering questions about risk factors and identifying low-cost testing services to providing linkages to local care, treatment options, and more Local Support To learn about news and events in your area, visit the American Liver Foundation website at and search in Resources under hepatitis C and your state. * Kadmon is not affiliated with any of the above mentioned groups. Kadmon therefore takes no responsibility for the advice they may provide or content of any material they provide to you or make publically available. Issued: April 2015 Item No.: C Copyright 2015 by Kadmon Pharmaceuticals, LLC. All rights reserved. 1 PEGASYS is a registered trademark of Hoffmann-La Roche Inc. 2 Videx and Videx EC is a registered trademark of Bristol-Myers Squibb Company 3 Imuran is a registered trademark of Prometheus Laboratories, Inc. 4 Azasan is a registered trademark of Salix Pharmaceuticals, Inc. DOSING GETTING STARTED YOUR TREATMENT PARTNER TIPS FOR REMEMBERING SERIOUS AND COMMON MANAGING TREATMENT PLEDGE COPAY SAVINGS CARD TALKING ABOUT HEP C RESOURCES AND SUPPORT FULL PRESCRIBING INFORMATION 2015 Kadmon Pharmaceuticals, LLC C November

15 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RIBASPHERE (ribavirin, USP) safely and effectively. See full prescribing information for RIBASPHERE (ribavirin, USP). RIBASPHERE (ribavirin, USP) Tablets for oral use Initial U.S. Approval: 2002 WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN- ASSOCIATED EFFECTS See full prescribing information for complete boxed warning. Ribavirin monotherapy, including Ribasphere, is not effective for the treatment of chronic hepatitis C virus infection (Boxed Warning). The hemolytic anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Ribasphere (2.3, 5.2, 6.1). Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, Ribasphere is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking Ribasphere therapy (4, 5.1, 8.1) INDICATIONS AND USAGE Ribasphere is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1) DOSAGE AND ADMINISTRATION CHC: Ribasphere is administered according to body weight and genotype (2.1) CHC with HIV coinfection: 800 mg by mouth daily for a total of 48 weeks, regardless of genotype (2.2) Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal impairment (2.3, 2.4) DOSAGE FORMS AND STRENGTHS Ribasphere (ribavirin, USP) tablets 200 mg (3) Ribasphere (ribavirin, USP) tablets 400 mg (3) Ribasphere (ribavirin, USP) tablets 600 mg (3) CONTRAINDICATIONS Pregnant women and men whose female partners are pregnant (4, 5.1, 8.1) Hemoglobinopathies (4) Coadministration with didanosine (4, 7.1) Ribasphere in combination with peginterferon alfa-2a is contraindicated in patients with: Autoimmune hepatitis (4) Hepatic decompensation in cirrhotic patients (4, 5.3) WARNINGS AND PRECAUTIONS Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests (4, 5.1, 8.1) Peginterferon alfa-2a/ribasphere: Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy: Hemolytic anemia may occur with a significant initial drop in hemoglobin. This may result in worsening cardiac disease leading to fatal or nonfatal myocardial infarctions (5.2, 6.1) Risk of hepatic failure and death: Monitor hepatic function during treatment and discontinue treatment for hepatic decompensation (5.3) Severe hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, and anaphylaxis, and serious skin reactions such as Stevens-Johnson Syndrome (5.4) Pulmonary disorders, including pulmonary function impairment and pneumonitis, including fatal cases of pneumonia (5.5) Severe depression and suicidal ideation, autoimmune and infectious disorders, suppression of bone marrow function, pancreatitis, and diabetes (5) Bone marrow suppression with azathioprine coadministration (5.6) Growth impairment with combination therapy in pediatric patients (5.8) ADVERSE REACTIONS The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1) The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Kadmon Pharmaceuticals at or FDA at FDA-1088 or DRUG INTERACTIONS Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities (7.1) Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity (7.3) USE IN SPECIFIC POPULATIONS Ribavirin Pregnancy Registry (8.1) Pediatrics: Safety and efficacy in pediatric patients less than 5 years old have not been established (8.4) Renal Impairment: Dose should be reduced in patients with creatinine clearance less than or equal to 50 ml/min (8.7) Organ Transplant: Safety and efficacy have not been studied (8.10) See 17 for PATIENT COUNSELING INFORMATION and FDAapproved Medication Guide. Revised: 08/2014 1

16 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN- ASSOCIATED EFFECTS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Chronic Hepatitis C Monoinfection 2.2 Chronic Hepatitis C with HIV Coinfection 2.3 Dose Modifications 2.4 Renal Impairment 2.5 Discontinuation of Dosing 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Pregnancy 5.2 Anemia 5.3 Hepatic Failure 5.4 Hypersensitivity 5.5 Pulmonary Disorders 5.6 Bone Marrow Suppression 5.7 Pancreatitis 5.8 Impact on Growth in Pediatric Patients 5.9 Laboratory Tests 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) 7.2 Drugs Metabolized by Cytochrome P Azathioprine 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Race 8.7 Renal Impairment 8.8 Hepatic Impairment 8.9 Gender 8.10 Organ Transplant Recipients 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology 14 CLINICAL STUDIES 14.1 Chronic Hepatitis C Patients 14.2 Other Treatment Response Predictors 14.3 Chronic Hepatitis C/HIV Coinfected Patients 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS Ribasphere monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication. The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Ribasphere [see Warnings and Precautions (5.2), Adverse Reactions (6.1), and Dosage and Administration (2.3)]. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Therefore, ribavirin, including Ribasphere, is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)]. 2

17 1 INDICATIONS AND USAGE Ribasphere (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating Ribasphere combination therapy with peginterferon alfa-2a: This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3. This indication is based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. Safety and efficacy data are not available for treatment longer than 48 weeks. The safety and efficacy of ribavirin and peginterferon alfa-2a therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy. The safety and efficacy of ribavirin therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. Ribasphere should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered. 2 DOSAGE AND ADMINISTRATION Ribasphere (ribavirin, USP) should be taken with food. Ribasphere should be given in combination with peginterferon alfa-2a; it is important to note that Ribasphere should never be given as monotherapy. See Peginterferon alfa-2a Package Insert for all instructions regarding peginterferon alfa-2a dosing and administration. 2.1 Chronic Hepatitis C Monoinfection Adult Patients The recommended dose of Ribasphere tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of Ribasphere is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1). Table 1 Peginterferon alfa-2a and Ribasphere Dosing Recommendations Hepatitis C Virus (HCV) Genotype Peginterferon alfa-2a Dose*(once weekly) Ribasphere Dose (daily) Duration Genotypes 1, 4 <75 kg = 1000 mg 48 weeks 180 mcg 75 kg = 1200 mg 48 weeks Genotypes 2, mcg 800 mg 24 weeks 3

18 Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10). Data on genotypes 5 and 6 are insufficient for dosing recommendations. *See Peginterferon alfa-2a Package Insert for further details on peginterferon alfa-2a dosing and administration, including dose modification in patients with renal impairment. Pediatric Patients Peginterferon alfa-2a is administered as 180 mcg/1.73m 2 x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks. Ribasphere should be given in combination with peginterferon alfa-2a. Ribasphere is available as a 200 mg, 400 mg and 600 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for Ribasphere are provided in Table 2. Patients who initiate treatment prior to their 18 th birthday should maintain pediatric dosing through the completion of therapy. Table 2 Ribasphere Dosing Recommendations for Pediatric Patients Body Weight in kilograms (kg) Ribasphere Daily Dose* Ribasphere Number of Tablets mg/day 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M mg/day 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M.** mg/day 2 x 200 mg tablets A.M.** 2 x 200 mg tablets P.M.** mg/day 2 x 200 mg tablets A.M.** 3 x 200 mg tablets P.M.*** mg/day 3 x 200 mg tablets A.M.*** 3 x 200 mg tablets P.M.*** *approximately 15 mg/kg/day **or 1 x 400 mg tablet ***or 1 x 600 mg tablet 2.2 Chronic Hepatitis C with HIV Coinfection Adult Patients The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and Ribasphere 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype. 2.3 Dose Modifications Adult and Pediatric Patients If severe adverse reactions or laboratory abnormalities develop during combination Ribasphere/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, Ribasphere/peginterferon alfa-2a therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient s hemoglobin concentration and cardiac status. 4

19 Ribasphere should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)]. Table 3 Body weight in kilograms (kg) Ribasphere Dose Modification Guidelines in Adults and Pediatrics Laboratory Values Hemoglobin <10 g/dl in patients Hemoglobin <8.5 g/dl in patients with no cardiac disease, or with no cardiac disease, or Decrease in hemoglobin of 2 g/dl during any 4 week period in patients with history of stable cardiac disease Adult Patients older than 18 years of age Any weight 1 x 200 mg tablet A.M. 2 x 200 mg tablets or 1 x 400 mg tablet P.M. Pediatric Patients 5 to 18 years of age kg 1 x 200 mg tablet A.M. Hemoglobin <12 g/dl despite 4 weeks at reduced dose in patients with history of stable cardiac disease Discontinue Ribasphere kg 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M kg 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M kg 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M. or 1 x 400 mg tablet P.M. 75 kg 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M. or 1 x 400 mg tablet P.M. Discontinue Ribasphere The guidelines for Ribasphere dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values. Adult Patients Once Ribasphere has been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Ribasphere at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that Ribasphere be increased to the original assigned dose (1000 mg to 1200 mg). Pediatric Patients Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in Ribasphere dose to the original dose may be attempted depending upon the physician s judgment. If Ribasphere has been withheld due 5

20 to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Ribasphere at onehalf the full dose. 2.4 Renal Impairment The total daily dose of Ribasphere should be reduced for patients with creatinine clearance less than or equal to 50 ml/min; and the weekly dose of peginterferon alfa-2a should be reduced for creatinine clearance less than 30 ml/min as follows in Table 4 [see Use in Specific Populations (8.7), Pharmacokinetics (12.3), and Peginterferon alfa-2a Package Insert]. Table 4 Dosage Modification for Renal Impairment Creatinine Peginterferon alfa-2a Ribasphere Dose (daily) Clearance Dose (once weekly) 30 to 50 ml/min 180 mcg Alternating doses, 200 mg and 400 mg every other day Less than mcg 200 mg daily ml/min Hemodialysis 135 mcg 200 mg daily The dose of Ribasphere should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, Ribasphere should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting Ribasphere, Ribasphere/peginterferon alfa-2a therapy should be discontinued. No data are available for pediatric subjects with renal impairment. 2.5 Discontinuation of Dosing Discontinuation of peginterferon alfa-2a/ribasphere therapy should be considered if the patient has failed to demonstrate at least a 2 log 10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy. Peginterferon alfa-2a/ribasphere therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)]. 3 DOSAGE FORMS AND STRENGTHS Ribasphere (ribavirin, USP) is available as tablets for oral administration. Each Ribasphere 200-mg tablet contains 200 mg of ribavirin, USP and is a capsule-shaped, light blue colored, film-coated tablet, debossed with 200 on one side and the logo 3RP on the other side. Each Ribasphere 400-mg tablet contains 400 mg of ribavirin, USP and is a capsule-shaped, medium blue colored, film-coated tablet, debossed with 400 on one side and the logo 3RP on the other side. Each Ribasphere 600-mg tablet contains 600 mg of ribavirin, USP and is a capsule-shaped, dark blue colored, film-coated tablet, debossed with 600 on one side and the logo 3RP on the other side. 6