HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VICTRELIS safely and effectively. See full prescribing information for VICTRELIS.
VICTRELIS™ (boceprevir) Capsules
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (≥18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. (1)
VICTRELIS must not be used as a monotherapy. (1)
DOSAGE AND ADMINISTRATION
800 mg administered orally three times daily (every 7 – 9 hours) with food (a meal or light snack). (2)
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. (2)
Refer to peginterferon alfa and ribavirin Package Inserts for specific dosing instructions. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg (3)
CONTRAINDICATIONS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. (4)
Because ribavirin may cause birth defects and fetal death, boceprevir in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. (4)
Coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. (4)
Potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. (4)
WARNINGS AND PRECAUTIONS
Use of VICTRELIS with Ribavirin and Peginterferon alfa:
Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; use two or more forms of contraception, and have monthly pregnancy tests. (5.1)
Anemia - The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared with peginterferon alfa and ribavirin alone. (5.2)
Neutropenia - The addition of VICTRELIS to peginterferon alfa and ribavirin may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. (5.3)
ADVERSE REACTIONS
The most commonly reported adverse reactions (greater than 35% of subjects) in clinical trials in adult subjects receiving the combination of VICTRELIS with PegIntron and REBETOL were fatigue, anemia, nausea, headache and dysgeusia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation, a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy. (4, 7, 12.3)
USE IN SPECIFIC POPULATIONS
Cirrhosis: Safety and efficacy have not been studied in patients with decompensated cirrhosis or in patients with an organ transplant. (8.7, 8.10)
Co-infection with Human Immunodeficiency Virus (HIV): Safety and efficacy have not been established i |
