What is the most important information I should know about OLYSIO®?
OLYSIO® can cause serious side effects, including:
What should I tell my healthcare provider before taking OLYSIO®?
Before taking OLYSIO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have ever had hepatitis B virus infection
-
have liver problems other than hepatitis C 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®?
-
OLYSIO® can cause serious side effects, including hepatitis B virus reactivation. See “What is the most important information I should know about OLYSIO®?”
-
The most common side effects in combination with sofosbuvir are tiredness, headache, and nausea.
-
The most common side effects in combination with peginterferon alfa and ribavirin 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 peginterferon alfa and ribavirin 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, including Boxed Warning, and Patient Information for more details.
041677-170215