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MEDICATION GUIDE

INCIVEK (in-SEE-veck)
(telaprevir)
Film-Coated Tablets

Read this Medication Guide before you start taking INCIVEK™ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

INCIVEK is taken along with peginterferon alfa and ribavirin. You should also read those Medication Guides.

What is the most important information I should know about INCIVEK?

INCIVEK combination treatment may cause serious side effects including:

1.
Birth defects or death of your unborn baby. INCIVEK in combination with 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 INCIVEK with peginterferon alfa and ribavirin and for 6 months after treatment is over.
If you are a female who can become pregnant, or you are a female whose male partner takes these medicines:

You must have a negative pregnancy test before starting treatment, each month during treatment, and for 6 months after your treatment ends.
You must use 2 forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control including birth control pills, vaginal rings, implants, or injections may not work during treatment with INCIVEK. You could become pregnant. Talk to your healthcare provider about other forms of birth control that may be used during this time. If your healthcare provider tells you to stop taking INCIVEK, peginterferon alfa and ribavirin, you must still use two forms of birth control for the 6 months after treatment with these medicines. You may use a hormonal form of birth control as one of your two forms of birth control after 2 weeks of stopping INCIVEK.
If you or your female sexual partner becomes pregnant while taking INCIVEK, peginterferon alfa, and ribavirin or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
2.
Skin reactions. Mild skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become severe and require treatment in a hospital.
Call your healthcare provider right away if you develop any skin changes with any of the symptoms below. Your healthcare provider will decide if your skin changes or symptoms may be a sign of a serious skin reaction:
rash, with or without itching
blisters or skin lesions
mouth sores or ulcers
red or inflamed eyes, like "pink eye" (conjunctivitis)
swelling of your face
fever
Your healthcare provider will decide if you need treatment for your rash or if you need to stop taking INCIVEK, or any of your other medicines.
Never stop taking INCIVEK com