HELPFUL TIPS WHEN FACING CHRONIC HEPATITIS C

Transcription

1 HELPFUL TIPS WHEN FACING CHRONIC HEPATITIS C STAYING PROACTIVE DURING TREATMENT No matter how chronic hepatitis C (genotype 1) entered your life, there are things you can do to stay proactive while you and your healthcare team work together. Fact is, it s important for you to stay engaged throughout your journey with hepatitis C. To help you throughout your hepatitis C treatment, we ve put together several points that may help you play an active role in confronting the disease with your healthcare team. STEP 1: FOLLOW YOUR MEDICATION SCHEDULE. It s very important that you take your dose of OLYSIO as prescribed by your healthcare provider. Take one OLYSIO capsule every day with food. Swallow OLYSIO capsule whole. Unless directed, do not change or stop your dose. If you think there is a reason to stop taking OLYSIO, discuss it with your healthcare provider. OLYSIO (simeprevir) is a prescription medicine used with other antiviral medicines (sofosbuvir or peginterferon and ribavirin) to treat genotype 1, chronic (lasting a long time) hepatitis C infection in adults. Talk to your doctor to learn more about treatment with OLYSIO. What to do if you miss a dose of OLYSIO. It s important to be compliant with your treatment schedule when taking OLYSIO. But if you miss a dose of OLYSIO, here s how to get back on track: If your next dose is due less than 12 hours from now, skip the missed dose and continue with your normal schedule. If your next dose is due more than 12 hours from now, take the missed dose now with food and continue with your normal schedule. Do not take 2 doses at the same time to make up for a missed dose. If you take too much OLYSIO, call your healthcare provider right away or go to the nearest hospital emergency room. PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 3 5 Page 1

2 STEP 2: SPEAK WITH YOUR PHYSICIAN ABOUT SIDE EFFECTS. The most common side effects of OLYSIO when used in combination with peginterferon alfa and ribavirin include: skin rash (see What is the most important information I should know about OLYSIO? in the Important Safety Information on page 3) itching nausea The most common side effects of OLYSIO when used in combination with sofosbuvir include: tiredness headache nausea Tell your healthcare provider if you have any side effect that bothers you or does not go away. STEP 3: MAINTAIN A HEALTHY LIFESTYLE. When trying to fight hepatitis C, establishing or maintaining a healthy lifestyle continues to be an important part of personal health. Just exercising regularly and eliminating unhealthy substances may have an impact on your overall health. How to start getting active. If you aren t already exercising, it s not too late to start. Check with your healthcare provider before beginning an exercise routine. Find something you enjoy to stay active activities like walking and gardening count. Consider starting with short activities, like a 10-minute walk after dinner. Exercise regularly as little as 30 minutes 3 times per week can be beneficial to your health. These are not all of the possible side effects of OLYSIO. For more information, ask your healthcare provider or pharmacist. PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 3 5 Page 2

3 How to eliminate damaging substances. The combination of hepatitis C and alcohol or harmful substances may be damaging to your liver. Don t feel you need to stop alone call up a healthcare provider, hospital, or self-help group and ask for information. Develop interests and friends unrelated to drinking or using. Avoid people, places, or things that make you want to drink. Keep a drinking diary and set realistic goals to cut back. LEARN MORE ABOUT OLYSIO AND OLYSIO SUPPORT AT OLYSIO.COM AND SUPPORT.OLYSIO.COM. What is OLYSIO? OLYSIO is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. OLYSIO should not be taken alone. It is not known if OLYSIO is safe and effective in children under 18 years of age. IMPORTANT SAFETY INFORMATION What is the most important information I should know about OLYSIO? If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO. It is not known if OLYSIO will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO. Females must use an effective form of birth control during treatment with OLYSIO. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO. OLYSIO combination treatment with sofosbuvir (Sovaldi ) may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone (Cordarone, Nexterone, Pacerone ), a medicine used to treat certain heart problems. If you are taking OLYSIO with sofosbuvir and amiodarone and you get any of the following symptoms, or if you have a slow heart rate call your healthcare provider right away: Fainting or near-fainting Dizziness or lightheadedness Weakness, extreme tiredness Chest pain, shortness of breath Confusion or memory problems Page 3

4 OLYSIO may cause severe liver problems in some patients. Your healthcare provider may do blood tests to check your liver function during treatment with OLYSIO. Your healthcare provider may tell you to stop taking OLYSIO if you develop signs and symptoms of liver problems. Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with OLYSIO : tiredness weakness loss of appetite nausea and vomiting yellowing of your skin or eyes color changes in your stools OLYSIO combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO. Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO. Limit sunlight exposure during treatment with OLYSIO. Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO. Call your healthcare provider right away if you get any of the following symptoms: burning, redness, swelling or blisters on your skin mouth sores or ulcers red or inflamed eyes, like pink eye (conjunctivitis) You should not take OLYSIO alone. OLYSIO should be used together with other medicines to treat chronic hepatitis C infection. What should I tell my healthcare provider before taking OLYSIO? Before taking OLYSIO, tell your healthcare provider if you: have liver problems other than hepatitis C virus infection have ever taken any medicine to treat hepatitis C virus infection had a liver transplant are receiving phototherapy have any other medical condition are of East Asian descent are breastfeeding. It is not known if OLYSIO passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO 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. OLYSIO and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO or other medicines in your body, which may affect the way OLYSIO or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist. Page 4

5 Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone, Nexterone, Pacerone ), amlodipine (Norvasc ), atazanavir (Reyataz ), atorvastatin (Lipitor, Caduet ), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol ), cisapride (Propulsid, Propulsid Quicksolv ), clarithromycin (Biaxin, Prevpac ), cobicistat-containing medicine (Stribild ), cyclosporine (Gengraf, Neoral, Sandimmune ), darunavir (Prezista ), delavirdine mesylate (Rescriptor ), dexamethasone, digoxin (Lanoxin ), diltiazem (Cardizem, Dilacor XR, Tiazac ), disopyramide (Norpace ), efavirenz (Sustiva, Atripla ), erythromycin (E.E.S., Eryc, Ery Tab, Erythrocin, Erythrocin Stearate ), etravirine (Intelence ), felodipine (Plendil ), flecainide (Tambocor ), fluconazole (Diflucan ), fosamprenavir (Lexiva ), indinavir (Crixivan ), itraconazole (Sporanox, Onmel ), ketoconazole (Nizoral ), lopinavir (Kaletra ), lovastatin (Advicor, Altoprev, Mevacor ), mexiletine (Mexitil ), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept ), nevirapine (Viramune, Viramune XR ), nicardipine (Cardene ), nifedipine (Adalat CC, Afeditab CR, Procardia ), nisoldipine (Sular ), oxcarbazepine (Oxtellar XR TM,Trileptal ), phenobarbital (Luminal ), phenytoin (Dilantin, Phenytek ), pitavastatin (Livalo ), posaconazole (Noxafil ), pravastatin (Pravachol ), propafenone (Rythmol SR ), quinidine (Nuedexta, Duraquin, Quinaglute ), rifabutin (Mycobutin ), rifampin (Rifadin, Rifamate, Rifater, Rimactane ), rifapentine (Priftin ), ritonavir (Norvir ), rosuvastatin (Crestor ), saquinavir mesylate (Invirase ), sildenafil (Revatio, Viagra ), simvastatin (Zocor, Vytorin, Simcor ), sirolimus (Rapamune ), St. John s wort (Hypericum perforatum) or products containing St. John s wort, tadalafil (Adcirca, Cialis ), telithromycin (Ketek ), tipranavir (Aptivus ), triazolam (Halcion ), verapamil (Calan, Covera HS, Isoptin, Tarka ), voriconazole (Vfend ). This is not a complete list of medicines that could interact with OLYSIO. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. 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 are the possible side effects of OLYSIO? The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea. The most common side effects in combination with sofosbuvir are tiredness, headache and nausea. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA When taking OLYSIO in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO in combination with sofosbuvir, you should also read its Patient Information leaflet. Please see full Prescribing Information and Patient Information for more details by visiting For more information about OLYSIO, go to or call Janssen Therapeutics, Division of Janssen Products, LP 2015 April Page 5

6 CARING FOR A LOVED ONE WITH CHRONIC HEPATITIS C AN INTRODUCTION FOR FAMILY, FRIENDS, AND CAREGIVERS If you re reading this brochure, chances are you re personally familiar with taking care of someone with hepatitis C. To help you navigate the feelings that can accompany your labor of love, we ve put together some useful tools, tips, and insights that may help. HELP KEEP TRACK OF YOUR LOVED ONE S MEDICATION. One of the most important things you can do if your loved one is being treated for hepatitis C with OLYSIO is to help them be compliant with their medication schedule. OLYSIO is used with other antiviral medicines sofosbuvir (interferon-free) or peginterferon and ribavirin to treat genotype 1, chronic (long-lasting) hepatitis C infection in adults. Create a schedule. Help your loved one create a daily schedule, then help them stick to it. They need to take their OLYSIO prescription once a day with food according to their physician s instructions. It s just as important that you help them stay on schedule with the antiviral drugs that are used in combination with OLYSIO as well. Know how they should be taking OLYSIO. Here are the guidelines your loved one should follow when taking OLYSIO : They should take OLYSIO exactly as their healthcare provider tells them to take it. They should not change their dose unless their healthcare provider tells them to. They should not stop taking OLYSIO unless their healthcare provider tells them to. If they think there is a reason to stop taking OLYSIO, they should talk to their healthcare provider before doing so. They should take 1 OLYSIO capsule each day with food. They should swallow OLYSIO capsules whole. PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 4-6 Page 1

7 Miss a dose of OLYSIO? It s very important to be compliant with the medication schedule. But if your loved one misses a dose of OLYSIO, here s how they can get back on track: If their next dose is due less than 12 hours from now, they should skip the missed dose and continue with their normal schedule. If their next dose is more than 12 hours from now, they should take the missed dose now with food and continue with their normal schedule. They should not take two doses at the same time to make up for a missed dose. If your loved one takes too much OLYSIO, call their healthcare provider right away or help them get to the nearest hospital emergency room. PROVIDING EMOTIONAL SUPPORT Here s how you can provide the person you re caring for with the personal support they may need: Encourage them to talk about their feelings with you, their doctor, friends, family members, clergy, or other people who can support them. Play an active role in finding activities that may help relieve their stress, such as exercise or hobbies. Help them get enough sleep. Sufficient rest may have an impact on emotional well-being. Encourage them to learn relaxation methods. This may include meditation, yoga, or deep breathing. Help them eat healthily. Proper nutrition can help contribute to overall well-being. Urge them to join a support group where they can discuss their feelings and experiences with hepatitis C. Visit support.olysio.com to help get them started. Health status and conditions may vary greatly from patient to patient. Speak with your loved one s healthcare provider for further information about providing emotional support to the person you re caring for. TAKING CARE OF YOURSELF (YES, THAT S OKAY) For your sake, and for the sake of the person you re caring for, it s important that you listen to your own needs and care for them accordingly. Here s how. First, know when stress is getting to you. There are many signs that stress is weighing you down. Here are a few of the most common: Frequently or constantly feeling tired Feeling angry, irritable, or just overwhelmed Sleeping too much or too little Gaining or losing lots of weight Losing interest in activities you previously enjoyed PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 4-6 Page 2

8 These may not be the only symptoms of stress. To learn more about signs of abnormal stress levels, speak with your healthcare provider. Second, find healthy, positive ways to cope. Here are some wholesome ways of coping with stress if it gets the better of you: Accept help when it s offered. Stay committed to your own health. Focus on what you re able to provide. Stay positive. Get connected with supportive friends or family. Join a caregiver support group. Maintain friendships (grab coffee, catch a movie, make a call). Set personal health goals and work toward them. Do something you enjoy every day. Make an appointment with your doctor. Get the facts before you react to new information. Take time to process new information. Take breaks from caregiving and other responsibilities. Find ways to laugh. HOW HEPATITIS C SPREADS Hepatitis C is a blood-borne disease, meaning it is transmitted by contact with infected blood. Here are several recommendations from the CDC and other health organizations: Do not share personal care items with persons infected with hepatitis C (eg, razor, toothbrush). Such items may be contaminated with infected blood. Do not use illicit drugs. If you use drugs, enter a substance abuse rehabilitation program. Do not share equipment for injecting drugs. Properly and safely dispose of any and all drug-injecting equipment, including those used for medical treatment. Avoid risky sexual contact and use barrier protection if you have HIV infection, multiple sexual partners, or a sexually transmitted disease. Clean surfaces and objects contaminated with visible blood. Hepatitis C virus can live on a dry surface for 4 days. Bandage any cuts or abrasions immediately (both you and the person living with hepatitis C) to avoid contamination with infected blood. These are not the only ways to stay protected from hepatitis C. For further advice, speak with your loved one s healthcare provider. PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 4-6 Page 3

9 Because hepatitis C can be spread only by direct contact with hepatitis C infected blood, the disease cannot be spread in the following ways: Sharing eating utensils Holding hands Coughing or sneezing Hugging or kissing Sharing food or drink Breastfeeding What is OLYSIO? LEARN MORE ABOUT OLYSIO AND OLYSIO SUPPORT AT OLYSIO.COM AND SUPPORT.OLYSIO.COM OLYSIO is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. OLYSIO should not be taken alone. It is not known if OLYSIO is safe and effective in children under 18 years of age. IMPORTANT SAFETY INFORMATION What is the most important information I should know about OLYSIO? If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO. It is not known if OLYSIO will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO. Females must use an effective form of birth control during treatment with OLYSIO. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO. OLYSIO combination treatment with sofosbuvir (Sovaldi ) may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone (Cordarone, Nexterone, Pacerone ), a medicine used to treat certain heart problems. If you are taking OLYSIO with sofosbuvir and amiodarone and you get any of the following symptoms, or if you have a slow heart rate call your healthcare provider right away: Fainting or near-fainting Dizziness or lightheadedness Weakness, extreme tiredness Chest pain, shortness of breath Confusion or memory problems Page 4

10 OLYSIO may cause severe liver problems in some patients. Your healthcare provider may do blood tests to check your liver function during treatment with OLYSIO. Your healthcare provider may tell you to stop taking OLYSIO if you develop signs and symptoms of liver problems. Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with OLYSIO : tiredness weakness loss of appetite nausea and vomiting yellowing of your skin or eyes color changes in your stools OLYSIO combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO. Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO. Limit sunlight exposure during treatment with OLYSIO. Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO. Call your healthcare provider right away if you get any of the following symptoms: burning, redness, swelling or blisters on your skin mouth sores or ulcers red or inflamed eyes, like pink eye (conjunctivitis) You should not take OLYSIO alone. OLYSIO should be used together with other medicines to treat chronic hepatitis C infection. What should I tell my healthcare provider before taking OLYSIO? Before taking OLYSIO, tell your healthcare provider if you: have liver problems other than hepatitis C virus infection have ever taken any medicine to treat hepatitis C virus infection had a liver transplant are receiving phototherapy have any other medical condition are of East Asian descent are breastfeeding. It is not known if OLYSIO passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO 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. OLYSIO and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO or other medicines in your body, which may affect the way OLYSIO or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist. Page 5

11 Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone, Nexterone, Pacerone ), amlodipine (Norvasc ), atazanavir (Reyataz ), atorvastatin (Lipitor, Caduet ), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol ), cisapride (Propulsid, Propulsid Quicksolv ), clarithromycin (Biaxin, Prevpac ), cobicistat-containing medicine (Stribild ), cyclosporine (Gengraf, Neoral, Sandimmune ), darunavir (Prezista ), delavirdine mesylate (Rescriptor ), dexamethasone, digoxin (Lanoxin ), diltiazem (Cardizem, Dilacor XR, Tiazac ), disopyramide (Norpace ), efavirenz (Sustiva, Atripla ), erythromycin (E.E.S., Eryc, Ery Tab, Erythrocin, Erythrocin Stearate ), etravirine (Intelence ), felodipine (Plendil ), flecainide (Tambocor ), fluconazole (Diflucan ), fosamprenavir (Lexiva ), indinavir (Crixivan ), itraconazole (Sporanox, Onmel ), ketoconazole (Nizoral ), lopinavir (Kaletra ), lovastatin (Advicor, Altoprev, Mevacor ), mexiletine (Mexitil ), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept ), nevirapine (Viramune, Viramune XR ), nicardipine (Cardene ), nifedipine (Adalat CC, Afeditab CR, Procardia ), nisoldipine (Sular ), oxcarbazepine (Oxtellar XR TM,Trileptal ), phenobarbital (Luminal ), phenytoin (Dilantin, Phenytek ), pitavastatin (Livalo ), posaconazole (Noxafil ), pravastatin (Pravachol ), propafenone (Rythmol SR ), quinidine (Nuedexta, Duraquin, Quinaglute ), rifabutin (Mycobutin ), rifampin (Rifadin, Rifamate, Rifater, Rimactane ), rifapentine (Priftin ), ritonavir (Norvir ), rosuvastatin (Crestor ), saquinavir mesylate (Invirase ), sildenafil (Revatio, Viagra ), simvastatin (Zocor, Vytorin, Simcor ), sirolimus (Rapamune ), St. John s wort (Hypericum perforatum) or products containing St. John s wort, tadalafil (Adcirca, Cialis ), telithromycin (Ketek ), tipranavir (Aptivus ), triazolam (Halcion ), verapamil (Calan, Covera HS, Isoptin, Tarka ), voriconazole (Vfend ). This is not a complete list of medicines that could interact with OLYSIO. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. 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 are the possible side effects of OLYSIO? The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea. The most common side effects in combination with sofosbuvir are tiredness, headache and nausea. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA When taking OLYSIO in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO in combination with sofosbuvir, you should also read its Patient Information leaflet. Please see full Prescribing Information and Patient Information for more details by visiting For more information about OLYSIO, go to or call Janssen Therapeutics, Division of Janssen Products, LP 2015 April Page 6

12 FINDING THE RIGHT HEPATITIS C SUPPORT AN INTRODUCTION FOR PATIENTS AND CAREGIVERS OLYSIO SUPPORT: INTEGRATED TOOLS FOR YOUR TREATMENT JOURNEY When it comes to treating chronic hepatitis C, genotype 1, you don t have to face it alone. From a medication reminder app and specialty pharmacies to financial assistance and local support groups, OLYSIO provides you and your loved ones the free resources you need. YOUR OLYSIO SUPPORT RESOURCES Online Treatment Calendar Stay current on your milestones. Care4Today Smartphone App Download your mobile medication tracker. Keeping track of your appointments and prescriptions may be complex. That s why OLYSIO Support created this easy-to-use calendar to help you stay on top of your appointments, support group sessions, and medication schedule. Set up your calendar at support.olysio.com/calendar Digital Support Group Finder Get connected to stay supported. Throughout your treatment journey, it s important to find support with others who are sharing a similar experience. OLYSIO Support has developed a support group locator that can help you find hepatitis C support groups close to where you live. Find a group at support.olysio.com/support-group PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 3-5 The Care4Today app is an easy-to-use tool that gives you options to manage your medication and prescription refill reminders, no matter where you are. Simply enter your medications into your smartphone, tablet, or computer, and Care4Today helps you set up medication reminders, set up prescription refill reminders, track how well you take your medication, and share information about your medication habits with your doctor. Caregivers can also use the app to monitor their loved one s prescription activity. Download your free app at olysio.com/support/care4today-app OLYSIO SUPPORT OLYSIO Monday Friday 8:00 AM 8:00 PM ET Page 1

13 Specialty Pharmacy Providers Explore available service offerings. Specialty Pharmacy Providers, or SPPs, can fill OLYSIO prescriptions and deliver them to your address. SPPs may also provide services, tools, and support for adults with chronic (long-lasting) hepatitis C. You may want to check with your SPP to see if they provide other services like financial assistance information, insurance management, and communication with nurses and pharmacists. Learn more about SPPs at olysio.com/support/pharmacy-locator Financial Assistance Get help for your prescription. There are several options for helping you reduce out-of-pocket costs of treatment, whether you have commercial insurance, government insurance, or you re uninsured. GET SUPPORT NOW. Sign up for OLYSIO Support and receive these tools and services and more. Enroll at support.olysio.com/registration What is OLYSIO? OLYSIO is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. OLYSIO should not be taken alone. It is not known if OLYSIO is safe and effective in children under 18 years of age. Get detailed information at olysio.com/support/financial-assistance Interactive Doctor Discussion Guide Keep the lines of communication open. Whether you re just about to start treatment or your treatment journey has already begun, there s a lot of information to keep track of and a lot of important questions that need to be asked. Our customizable Doctor Discussion Guide helps you organize your thoughts and keep key questions top of mind. Download your guide at support.olysio.com/doctor-discussion PLEASE READ IMPORTANT SAFETY INFORMATION ON PAGES 3-5 OLYSIO SUPPORT OLYSIO Monday Friday 8:00 AM 8:00 PM ET Page 2

14 IMPORTANT SAFETY INFORMATION What is the most important information I should know about OLYSIO? If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO. It is not known if OLYSIO will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO. Females must use an effective form of birth control during treatment with OLYSIO. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO. OLYSIO combination treatment with sofosbuvir (Sovaldi ) may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone (Cordarone, Nexterone, Pacerone ), a medicine used to treat certain heart problems. If you are taking OLYSIO with sofosbuvir and amiodarone and you get any of the following symptoms, or if you have a slow heart rate call your healthcare provider right away: Fainting or near-fainting Dizziness or lightheadedness Weakness, extreme tiredness Chest pain, shortness of breath Confusion or memory problems OLYSIO may cause severe liver problems in some patients. Your healthcare provider may do blood tests to check your liver function during treatment with OLYSIO. Your healthcare provider may tell you to stop taking OLYSIO if you develop signs and symptoms of liver problems. Tell your healthcare provider right away if you develop any of the following symptoms, or if they worsen during treatment with OLYSIO : tiredness weakness loss of appetite nausea and vomiting yellowing of your skin or eyes color changes in your stools OLYSIO SUPPORT OLYSIO Monday Friday 8:00 AM 8:00 PM ET Page 3

15 OLYSIO combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO. Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO. Limit sunlight exposure during treatment with OLYSIO. Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO. Call your healthcare provider right away if you get any of the following symptoms: burning, redness, swelling or blisters on your skin mouth sores or ulcers red or inflamed eyes, like pink eye (conjunctivitis) You should not take OLYSIO alone. OLYSIO should be used together with other medicines to treat chronic hepatitis C infection. What should I tell my healthcare provider before taking OLYSIO? Before taking OLYSIO, tell your healthcare provider if you: have liver problems other than hepatitis C virus infection have ever taken any medicine to treat hepatitis C virus infection had a liver transplant are receiving phototherapy have any other medical condition are of East Asian descent are breastfeeding. It is not known if OLYSIO passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO 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. OLYSIO and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO or other medicines in your body, which may affect the way OLYSIO or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist. OLYSIO SUPPORT OLYSIO Monday Friday 8:00 AM 8:00 PM ET Page 4

16 Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone, Nexterone, Pacerone ), amlodipine (Norvasc ), atazanavir (Reyataz ), atorvastatin (Lipitor, Caduet ), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol ), cisapride (Propulsid, Propulsid Quicksolv ), clarithromycin (Biaxin, Prevpac ), cobicistat-containing medicine (Stribild ), cyclosporine (Gengraf, Neoral, Sandimmune ), darunavir (Prezista ), delavirdine mesylate (Rescriptor ), dexamethasone, digoxin (Lanoxin ), diltiazem (Cardizem, Dilacor XR, Tiazac ), disopyramide (Norpace ), efavirenz (Sustiva, Atripla ), erythromycin (E.E.S., Eryc, Ery Tab, Erythrocin, Erythrocin Stearate ), etravirine (Intelence ), felodipine (Plendil ), flecainide (Tambocor ), fluconazole (Diflucan ), fosamprenavir (Lexiva ), indinavir (Crixivan ), itraconazole (Sporanox, Onmel ), ketoconazole (Nizoral ), lopinavir (Kaletra ), lovastatin (Advicor, Altoprev, Mevacor ), mexiletine (Mexitil ), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept ), nevirapine (Viramune, Viramune XR ), nicardipine (Cardene ), nifedipine (Adalat CC, Afeditab CR, Procardia ), nisoldipine (Sular ), oxcarbazepine (Oxtellar XR TM,Trileptal ), phenobarbital (Luminal ), phenytoin (Dilantin, Phenytek ), pitavastatin (Livalo ), posaconazole (Noxafil ), pravastatin (Pravachol ), propafenone (Rythmol SR ), quinidine (Nuedexta, Duraquin, Quinaglute ), rifabutin (Mycobutin ), rifampin (Rifadin, Rifamate, Rifater, Rimactane ), rifapentine (Priftin ), ritonavir (Norvir ), rosuvastatin (Crestor ), saquinavir mesylate (Invirase ), sildenafil (Revatio, Viagra ), simvastatin (Zocor, Vytorin, Simcor ), sirolimus (Rapamune ), St. John s wort (Hypericum perforatum) or products containing St. John s wort, tadalafil (Adcirca, Cialis ), telithromycin (Ketek ), tipranavir (Aptivus ), triazolam (Halcion ), verapamil (Calan, Covera HS, Isoptin, Tarka ), voriconazole (Vfend ). This is not a complete list of medicines that could interact with OLYSIO. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. 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 are the possible side effects of OLYSIO? The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea. The most common side effects in combination with sofosbuvir are tiredness, headache and nausea. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA When taking OLYSIO in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO in combination with sofosbuvir, you should also read its Patient Information leaflet. Please see full Prescribing Information and Patient Information for more details by visiting For more information about OLYSIO and OLYSIO Support, go to and support.olysio.com or call Janssen Therapeutics, Division of Janssen Products, LP 2015 April Page 5