aindications (4), Warnings and Precautions (5.4), Drug Interactions (7), and Clinical Pharmacology (12.3)].
Patients should be advised that the total daily dose of VICTRELIS is packaged into a single bottle containing 12-capsules and the patient should take four capsules three times daily with food.
17.5 Missed VICTRELIS Doses
If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose should be skipped. If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule.
17.6 Hepatitis C Virus Transmission
Patients should be informed that the effect of treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of the hepatitis C virus should be taken.
Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
U.S. Patent Nos. 7,012,066; 7,244,721
Trademarks depicted herein are the property of their respective owners.
Copyright © 2011 Schering Corporation, a subsidiary of Merck & Co., Inc. All rights reserved.
Issued: 05/11
34965510T
MEDICATION GUIDE
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 m |
