How To Take Pegasys

Transcription

1 Models are for illustrative purposes only. REACH FOR ANSWERS A guide to understanding chronic hepatitis C treatment with PEGASYS+ribavirin + sofosbuvir INDICATIONS What is PEGASYS? PEGASYS (peginterferon alfa-2a) is a prescription medication that is: used with other hepatitis C medicines to treat adults with chronic (lasting a long time) hepatitis C and certain types of liver problems used with a hepatitis C medicine called ribavirin to treat adults and children 5 years and older with chronic hepatitis C and certain types of liver problems used alone to treat chronic hepatitis C only if you are not able to take other hepatitis C medicines not recommended to be used alone or with a hepatitis C medicine called ribavirin without additional hepatitis C medicines if you have taken an alpha interferon not recommended to treat chronic hepatitis C if you have had a solid organ transplant used to treat adults with chronic hepatitis B virus who show signs that the virus is damaging the liver It is not known if PEGASYS is safe and will work in children under 5 years of age. What is Sofosbuvir? Sofosbuvir is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. Sofosbuvir should not be taken alone. It is not known if sofosbuvir is safe and effective in children under 18 years of age. IMPORTANT Boxed WARNING PEGASYS PEGASYS, like other alpha interferons, may cause or worsen fatal or life-threatening problems (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In many patients, but not all, these conditions get better after they stop taking PEGASYS (see the Medication Guide for more information and Warnings). For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/ Patient Information, including Boxed WARNING for PEGASYS.

2 TABLE OF CONTENTS What is the most important information I should know about sofosbuvir? Sofosbuvir, in combination with ribavirin or peginterferon alfa and ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking sofosbuvir with ribavirin or in combination with peginterferon alfa and ribavirin, and for 6 months after treatment is over. Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with sofosbuvir and ribavirin or in combination with peginterferon alfa and ribavirin. Talk to your healthcare provider about forms of birth control that may be used during this time. Females must have a negative pregnancy test before starting treatment with sofosbuvir and ribavirin or in combination with peginterferon alfa and ribavirin, every month while being treated, and for 6 months after your treatment ends. If you or your female sexual partner becomes pregnant while taking or within 6 months after you stop taking sofosbuvir and ribavirin, or sofosbuvir in combination with peginterferon alfa and ribavirin, 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 ribavirin while she is pregnant. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available at Know the basics of chronic hepatitis C 4 What is chronic hepatitis C? What does my liver do? Symptoms of chronic hepatitis C Treating chronic hepatitis C 6 Can chronic hepatitis C be treated? What is PEGASYS? Triple therapy with PEGASYS, ribavirin, and sofosbuvir 8 Treatment duration is 12 weeks Clinical study results 10 PEGASYS, ribavirin, and sofosbuvir were studied in adult patients with genotype 1 and 4 chronic hepatitis C who have not been treated before Patient assistance 11 Access Solutions Patient Support Services* Important Safety Information 14 * These resources are for general educational purposes only and are not intended to convey or be a substitute for the medical advice of your healthcare provider. Your healthcare provider should always be your primary source of information about your health, diagnosis, and treatment. For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/Patient Information, including Boxed WARNING for PEGASYS. 3

3 KNOW THE BASICS OF CHRONIC HEPATITIS C What is chronic hepatitis C? Chronic hepatitis C is a disease caused by a virus that attacks the liver. The virus enters the body through contact with the blood of another person who has the virus. The term chronic means lasting for a long time. Chronic hepatitis C is a lifelong infection that may affect the liver. Stages of liver disease Normal Mild fibrosis (scarring) Moderate fibrosis Cirrhosis (severe scarring) To understand why chronic hepatitis C is a serious concern, it will help to know what the liver does. What does my liver do? The liver is an important part of your body, and it does a lot to keep you healthy: Removes harmful substances, called toxins, from the blood Stores vitamins, minerals, and cholesterol Symptoms of chronic hepatitis C People with chronic hepatitis C may not have symptoms right away. In the United States, more than 3 million people have chronic hepatitis C. Many don t even know that they have it. That s because people who have the disease might not look or feel sick. People with chronic hepatitis C may not have symptoms for a number of years. When they appear, symptoms may include dark urine, fatigue, jaundice (yellowing of the skin and eyeballs), loss of appetite, fever, nausea, vomiting, and abdominal pain. Talk with your healthcare provider about what you can do to stay healthy. Liver YOUR LIVER IS IMPORTANT FOR KEEPING YOU HEALTHY. 4 5

4 TREATING CHRONIC HEPATITIS C Can chronic hepatitis C be treated? Although chronic hepatitis C is a serious disease, it can be treated. THE GOAL OF TREATMENT IS SUSTAINEd VIROLOGIC RESPONSE (SVR). SVR MEANS THE HEPATITIS C VIRUS CANNOT BE MEASUREd IN YOUR BLOOd 12 WEEKS AFTER YOU FINISH ALL TREATMENT. Your healthcare provider will use a blood test to check the level of virus (called viral load) in your body Viral load is measured in international units, or IU, per milliliter of blood SVR is achieved if there are less than 25 IU of virus per milliliter of blood at 12 weeks after the end of treatment 12 weeks after end of treatment, your doctor checks for SVR Blood tests also help your healthcare provider check your overall health. During treatment, you will have these blood tests on a regular schedule. What is the most important information I should know about sofosbuvir? (cont d) You should not take sofosbuvir alone. Sofosbuvir should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection. What is PEGASYS? PEGASYS is a medicine that is used to treat chronic hepatitis C. PEGASYS is a kind of interferon (in-ter-feer-on) called pegylated interferon alfa-2a. Interferon is a chemical that your body makes. While the interferon that s used for injection is slightly different from the kind your body makes, it may help the body defeat the virus by Helping healthy cells defend themselves against viruses Boosting the activity of the immune system against the invading virus to stop the virus from multiplying What is the most important information I should know about PEGASYS? Ribavirin in combination with PEGASYS may cause birth defects or death of your unborn baby PEGASYS therapy may cause you to develop mood or behavioral problems Some people who take PEGASYS alone or in combination with ribavirin may get heart problems Stroke or symptoms of a stroke Some people taking PEGASYS develop new or worsening autoimmune problems Some people who take PEGASYS may get an infection For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/Patient Information, including Boxed WARNING for PEGASYS. 6 7

5 TRIPLE THERAPY WITH PEGASYS, RIBAVIRIN, ANd SOFOSBUVIR PEGASYS can be used in this combination to treat adult patients with genotype 1 and 4 chronic hepatitis C. Be sure to talk with your healthcare provider about what genotype you are and whether treatment is appropriate for you. Treatment duration is 12 weeks *Image for illustrative purposes only. PEGASYS is an injection you take once a week Ribavirin is a pill you take with food 2 times a day or as your healthcare provider prescribes Sofosbuvir is a tablet taken once a day with or without food What is the most important information I should know about PEGASYS? (cont d) PEGASYS alone or in combination with ribavirin can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of these symptoms while taking PEGASYS. Who should not take PEGASYS? Do not take PEGASYS if you: have certain other liver problems have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS You should not take sofosbuvir alone. Sofosbuvir should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection. Each medicine has an important purpose, and all work together to help your body fight the virus. That s why it s important to take all 3 medicines exactly as your healthcare provider tells you. The information in this brochure is limited to the use of sofosbuvir in combination with PEGASYS and ribavirin for the treatment of adult patients with genotype 1 or 4 chronic hepatitis C. The treatment regimen and duration of sofosbuvir are dependent on both viral genotype and patient population. Please refer to the sofosbuvir Full Prescribing Information and Patient Information. For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/Patient Information, including Boxed WARNING for PEGASYS. 8 9

6 CLINICAL STUdY RESULTS PEGASYS, ribavirin, and sofosbuvir were studied in adult patients with genotype 1 and 4 chronic hepatitis C who have not been treated before PATIENT ASSISTANCE Help at every step of the way There is support available if you and your healthcare provider decide that chronic hepatitis C virus treatment with PEGASYS is appropriate for you. In a clinical study, after 12 weeks of therapy: of all patients achieved SVR* (295 of 327) This study also included 7 patients with genotype 5 or 6. of genotype 1 patients achieved SVR* (261 of 292) of genotype 4 patients achieved SVR* (27 of 28) * SVR means virus is not detectable (less than 25 IU of virus per milliliter of blood) 12 weeks after the end of treatment. Who should not take PEGASYS? (cont d) Do not take PEGASYS in combination with ribavirin if you: are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with ribavirin or during the 6 months after your treatment has ended Access Solutions helps connect you to your prescribed treatment The consequences to patients with financial concerns might be significant. We are committed to helping all patients access our medicines, regardless of their ability to pay. If you have no insurance, or your health insurance plan denies you coverage for PEGASYS, you can work with your healthcare provider s office to apply to the Genentech Access to Care Foundation for free medicine. Visit Genentech-Access.com/PEGASYS for more information on our programs. If you would like to speak with an operator about the Co-Pay Card Program, call from 8 am to 8 pm ET, Monday through Friday. The Access Solutions logo is a registered trademark of Genentech, Inc. For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/Patient Information, including Boxed WARNING for PEGASYS

7 PATIENT ASSISTANCE Patient Support Services can help you feel ready and supported during treatment* Many people starting treatment for chronic hepatitis C have questions or concerns, but there is no reason to feel as if you are on your own. Our educational resources can help answer some of the questions you may have during your treatment. *These resources are for general educational purposes only and are not intended to convey or be a substitute for the medical advice of your healthcare provider. Your healthcare provider should always be your primary source of information about your health, diagnosis, and treatment. Patient starter kit A free tool kit with educational resources, including Travel case and sharps container for the safe disposal of autoinjectors or needles Treatment guide PEGASYS.com Your online source for information throughout your treatment, featuring the information and tools you need in one convenient location. These include: Information about chronic hepatitis C Information about treatment with PEGASYS and side effect information Tips on healthy living Downloadable resources section for additional information Who should not take PEGASYS? (cont d) Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death. CONTACT YOUR HEALTHCARE PROVIdER IF YOU WOULd LIKE TO ORdER A STARTER KIT. FOR MORE INFORMATION, CALL PEGASYS ( ) OR VISIT For additional Important Safety Information, please see pages Please also see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING

8 IMPORTANT SAFETY INFORMATION (CONT d) What is the most important information I should know about sofosbuvir? Please see the PEGASYS Medication Guide for more important safety information in the What is the most important information I should know about PEGASYS alone or in combination with ribavirin? You should not take sofosbuvir alone. Sofosbuvir should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection. What is the most important information I should know about PEGASYS alone or in combination with ribavirin? 1. Ribavirin in combination with PEGASYS may cause birth defects or death of your unborn baby. Females must have pregnancy tests before, during and for 6 months after PEGASYS/ribavirin combination therapy. During treatment and for 6 months after treatment, female and male patients must: use 2 forms of birth control, one being a condom with spermicide inform their healthcare provider if pregnancy occurs while taking PEGASYS/ribavirin or within 6 months after stopping PEGASYS/ribavirin therapy. Patients or their healthcare provider should contact the Ribavirin Pregnancy Registry by calling Mental health problems and suicide. PEGASYS therapy may cause you to develop mood or behavioral problems, including: irritability (getting upset easily) depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety aggressive behavior former drug addicts may fall back into drug addiction or overdose thoughts of hurting yourself or others, or suicide 3. Heart problems. Some people who take PEGASYS alone or in combination with ribavirin may get heart problems, including: high blood pressure fast heart rate or abnormal heart beat chest pain heart attacks 4. Stroke or symptoms of a stroke. Symptoms may include weakness, loss of coordination, and numbness. 5. New or worsening autoimmune problems. Some people taking PEGASYS develop autoimmune problems (a condition where the body s immune cells attack other cells or organs in the body), such as rheumatoid arthritis, lupus, and psoriasis. 6. Infections. Some people who take PEGASYS may get an infection. Symptoms may include: fever chills burning and painful urination urinating often coughing up yellow or pink mucus (phlegm) PEGASYS alone or in combination with ribavirin can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of these symptoms while taking PEGASYS. Who should not take PEGASYS? Do not take PEGASYS if you: have certain other liver problems have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS. Symptoms of a serious allergic reaction to alpha interferon may include: itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain Please see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING, for additional Important Safety Information. Please see accompanying sofosbuvir Full Prescribing Information and Patient Information for additional Important Safety Information

9 IMPORTANT SAFETY INFORMATION (CONT d) Who should not take PEGASYS? (cont d) Do not take PEGASYS in combination with ribavirin if you: are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with ribavirin or during the 6 months after your treatment has ended Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death. Before taking PEGASYS, tell your healthcare provider about all your medical conditions or problems, and if you are pregnant or breastfeeding, or plan to become pregnant or breast-feed during treatment with PEGASYS. What should I tell my healthcare provider before taking sofosbuvir? Before taking sofosbuvir, tell your healthcare provider if you: have liver problems other than hepatitis C infection have had a liver transplant have severe kidney problems or you are on dialysis have HIV have any other medical condition are breastfeeding or plan to breastfeed. It is not known if sofosbuvir passes into your breast milk. You and your healthcare provider should decide if you will take sofosbuvir or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how sofosbuvir works. Especially tell your healthcare provider if you take any of the following medicines: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol ), oxcarbazepine (Trileptal, Oxtellar XR TM ), phenytoin (Dilantin, Phenytek ), phenobarbital (Luminal ), rifabutin (Mycobutin ), rifampin (Rifadin, Rifamate, Rifater, Rimactane ), rifapentine (Priftin ), St. John s wort (Hypericum perforatum) or a product that contains St. John s wort, tipranavir (Aptivus ). Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. What should I tell my healthcare provider before taking PEGASYS? Before taking PEGASYS, tell your healthcare provider if you have: liver problems (other than hepatitis B or C) or had lung problems thyroid problems diabetes colitis (inflammation of your intestine) cancer hepatitis B or C infection HIV infection (the virus that causes AIDS) kidney problems high blood triglyceride levels (fat in your blood) an organ transplant any other medical conditions are pregnant or plan to become pregnant. It is not known if PEGASYS will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with PEGASYS are breastfeeding or plan to breast-feed. It is not known if PEGASYS passes into your breast milk. You and your healthcare provider should decide if you will use PEGASYS or breastfeed. You should not do both Please see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING, for additional Important Safety Information. Please see accompanying sofosbuvir Full Prescribing Information and Patient Information for additional Important Safety Information

10 IMPORTANT SAFETY INFORMATION (CONT d) What should I tell my healthcare provider before taking PEGASYS? (cont d) Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. What should I avoid while taking PEGASYS, or PEGASYS with ribavirin? If you are pregnant do not start taking or continue taking PEGASYS alone or in combination with ribavirin. Ribavirin in combination with PEGASYS may cause birth defects or death of your unborn baby Avoid becoming pregnant while taking PEGASYS, alone or in combination with ribavirin. PEGASYS, alone or in combination with ribavirin, may harm your unborn child (death or serious birth defects) or cause you to lose your baby (miscarry) Do not breast-feed your baby while on PEGASYS, alone or in combination with ribavirin Drinking alcohol, including beer, wine and liquor. This may make your liver disease worse Taking other medicines. Take only medicines prescribed or approved by your healthcare provider. These include prescription and nonprescription medicines and herbal supplements What are the most common side effects of sofosbuvir? When used in combination with ribavirin: tiredness and headache. When used in combination with peginterferon-alfa and ribavirin: tiredness, headache, nausea, difficulty sleeping and low red blood cell count. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. What are the possible side effects of PEGASYS? PEGASYS can cause serious side effects including: blood problems. PEGASYS can affect your bone marrow and cause low red blood cell, low white blood cell, and platelet counts thyroid problems blood sugar problems. Some people may develop high blood sugar or diabetes. serious eye problems. PEGASYS may cause eye problems that may lead to vision loss or blindness serious liver problems, worsening of liver problems, including liver failure and death lung problems, including: trouble breathing pneumonia inflammation of lung tissue new or worse high blood pressure of the lungs (pulmonary hypertension). This can be severe and may lead to death inflammation of your pancreas (pancreatitis) inflammation of your intestines (colitis) serious allergic reactions and skin reactions effect on growth in children. Children can experience a delay in weight gain and height increase while being treated with PEGASYS and COPEGUS. Catch-up in growth happens after treatment stops, but some children may not reach the height that they were expected to have before treatment. nerve problems. People who take PEGASYS or other alpha interferon products with telbivudine (Tyzeka ) for hepatitis B can develop nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy) The most common, but less serious, side effects of PEGASYS include: flu-like symptoms tiredness and weakness stomach problems loss of appetite skin reactions hair thinning trouble sleeping Please see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING, for additional Important Safety Information. Please see accompanying sofosbuvir Full Prescribing Information and Patient Information for additional Important Safety Information

11 IMPORTANT SAFETY INFORMATION (CONT d) NOTES What are the possible side effects of PEGASYS? (cont d) Tell your healthcare provider right away if you believe you may have any of the PEGASYS or sofosbuvir side effects that bother you or that do not go away. These are not all the possible side effects of PEGASYS/ribavirin or sofosbuvir. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at FDA-1088 or You may also report side effects to Genentech at Please see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING, for additional Important Safety Information. Please see accompanying sofosbuvir Full Prescribing Information and Patient Information for additional Important Safety Information

12 NOTES REACH FOR ANSWERS TODAY Talking to your doctor is the first step in taking charge of your health If you are diagnosed with chronic hepatitis C, ask your doctor about triple therapy with PEGASYS, ribavirin, and sofosbuvir. You and your doctor can decide if starting therapy is right for you. Here are some questions that can help guide your discussion. What is my genotype? Triple therapy with PEGASYS, ribavirin, and sofosbuvir can only be used for adult patients with genotypes 1 and 4. It is important to find out what your genotype is What other information about my condition is important to know? It is helpful for you and your doctor to know certain facts about your condition, such as What is your viral load? Are there any other tests you need to take to check your liver health? When could you have been infected? How long could you have been infected for? Can my lifestyle complicate my condition? Because the hepatitis C virus attacks the liver, your doctor should know about lifestyle habits that may also affect the liver, such as drinking alcoholic beverages What are the risks of treatment? Who should not take PEGASYS? (cont d) Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death. Before taking PEGASYS, tell your healthcare provider about all your medical conditions or problems, and if you are pregnant or breastfeeding, or plan to become pregnant or breast feed during treatment with PEGASYS. 22 Take the first step and talk to your doctor about treatment. For additional Important Safety Information, please see pages Please also see accompanying PEGASYS and sofosbuvir Full Prescribing Information and Medication Guide/Patient Information, including Boxed WARNING for PEGASYS. 23

13 LEARN MORE These are some resources for more information about chronic hepatitis C American Liver Foundation GO-LIVER ( ) Centers for Disease Control and Prevention (CDC) CDC-INFO ( ) Hep C Connection HEPC ( ) Genentech is neither affiliated with nor endorses any of the above organizations. Genentech makes no representation as to the accuracy of the information contained on sites we do not own or control. For more information about PEGASYS Talk with your healthcare provider Visit or call PEGASYS ( ) Scan with your smartphone using a QR reader app. For additional Important Safety Information, please see pages Please also see accompanying PEGASYS Full Prescribing Information and Medication Guide, including Boxed WARNING. PEGASYS and COPEGUS are registered trademarks of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc Genentech USA, Inc. All rights reserved. PEG/102214/0022 Printed in USA. (12/14)