VICTRELIS™ (vĭc-TRÉL-ĭs)

(boceprevir)

Read this Medication Guide before you start taking VICTRELIS, and each time you get a refill. There may be important new information. This information does not take the place of talking with your doctor, nurse or physician assistant (healthcare provider) about your medical condition or your care.

VICTRELIS 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 VICTRELIS?

VICTRELIS, 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 VICTRELIS, peginterferon alfa, and ribavirin combination therapy and for 6 months after treatment is over.

 

• Females and males must use 2 forms of birth control during treatment and for 6 months after treatment with VICTRELIS, peginterferon alfa, and ribavirin. Hormonal forms of birth control, such as birth control pills, vaginal rings, implants and injections, may not work as well during treatment with VICTRELIS. You may get pregnant while using these birth control methods while on VICTRELIS. Talk to your healthcare provider about other forms of birth control that may be used during this time.
• Females must have a pregnancy test before starting treatment with VICTRELIS combination therapy, every month while being treated, and every month for 6 months after treatment with VICTRELIS, peginterferon alfa, and ribavirin is over.
• If you or your female sexual partner becomes pregnant while taking VICTRELIS, 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.

• Do not take VICTRELIS alone to treat chronic hepatitis C infection. VICTRELIS must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.

What is VICTRELIS?

VICTRELIS is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults who have not been treated before or who have failed previous treatment.

It is not known if VICTRELIS is safe and effective in children under 18 years of age.

Who should not take VICTRELIS?

See "What is the most important information I should know about VICTRELIS?"

Do not take VICTRELIS if you:

• take certain medicines. VICTRELIS may cause serious side effects when taken with certain medicines. Read the section "What should I tell my healthcare provider before taking VICTRELIS?"

Talk to your healthcare provider before taking VICTRELIS if you have any of the conditions listed below.

What should I tell my healthcare provider before taking VICTRELIS?

Before you take VICTRELIS, tell your healthcare provider if you: