Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has been stopped; routine monthly pregnancy tests must be performed during this time. Because systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS, two alternative effective methods of contraception, such as intrauterine devices and barrier methods, should be used in women during treatment with VICTRELIS and concomitant ribavirin [see Warnings and Precautions (5.1)].

To monitor maternal and fetal outcomes of pregnant women exposed to ribavirin, the Ribavirin Pregnancy Registry has been established. Patients should be encouraged to register by calling 1-800-593-2214.

17.2Anemia

Patients should be informed that anemia may be increased when VICTRELIS is administered with peginterferon alfa and ribavirin [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. Patients should be advised that laboratory eva luations are required prior to starting therapy and periodically thereafter [see Warnings and Precautions (5.5)].

17.3Neutropenia

Patients should be informed that neutropenia may be increased when VICTRELIS is administered with peginterferon alfa and ribavirin [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)]. Patients should be advised that laboratory eva luations are required prior to starting therapy and periodically thereafter [see Warnings and Precautions (5.5)].

17.4Usage Safeguards

Patients should be advised that VICTRELIS must not be used alone due to the high probability of resistance without combination anti-HCV therapies [see Indications and Usage (1)]. See peginterferon alfa and ribavirin Package Inserts for additional patient counseling information on the use of these drugs in combination with VICTRELIS.

Patients should be informed of the potential for serious drug interactions with VICTRELIS, and that some drugs should not be taken with VICTRELIS [see Contraindications (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.

17.5Missed 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.

17.6Hepatitis 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

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