IMPORTANT SAFETY INFORMATION
What is OLYSIO®?
- OLYSIO® (simeprevir) is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C virus genotype 1 infection. OLYSIO® should not be taken alone. OLYSIO® is not for people with certain types of liver problems. It is not known if OLYSIO® is safe and effective in children under 18 years of age.
What is the most important information I should know about OLYSIO®?
OLYSIO® may cause serious side effects, including:
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 people. These severe liver problems may lead to liver failure or death.
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®:
- 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®.
- Limit sunlight exposure during treatment with OLYSIO®.
- Use sunscreen and wear a hat, sunglasses, and protective clothing 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)
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 pregnant or plan to become pregnant. It is not known if OLYSIO® will harm your unborn baby. Do not take OLYSIO® in combination with ribavirin if you are pregnant, or your sexual partner is pregnant.
- Females who take OLYSIO® in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping ribavirin. Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with OLYSIO® in combination with ribavirin.
- Males and females who take OLYSIO® with ribavirin should read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
are breastfeeding. It is not known if OLYSIO® passes into your breast milk.
Talk to your healthcare provider about the best way to feed your baby during treatment with OLYSIO®.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with OLYSIO®. 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. Keep a list of your medicines and show it to your healthcare provider and pharmacist.
- You can ask your healthcare provider or pharmacist for a list of medicines that interact with OLYSIO®.
- Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take OLYSIO® with other medicines.
What are the possible side effects of OLYSIO®?
- The most common side effects in combination with sofosbuvir are tiredness, headache, and nausea.
- The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching, 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 are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Important: You should not take OLYSIO® alone. OLYSIO® should be used together with other antiviral medicines to treat chronic hepatitis C virus infection. 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.