Victrelis :FDA Approves Victrelis to Fight Hepatitis C
FRIDAY, May 13 -- The U.S. Food and Drug Administration late Friday gave approval to Victrelis (boceprevir), one of a new class of drugs aimed at fighting chronic hepatitis C infection.
According to The New York Times, the new drug appears to help more people clear the virus from their system in a shorter time span than older medications. In one trial sponsored by the drug's maker, Merck, 44 percent of patients were successfully treated within 28 weeks instead of the typical 48.
Victrelis Medication Guide
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.
Important information 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.
Comments