n patients co-infected with HCV and HIV. (8.8)
Co-infection with Hepatitis B Virus (HBV): Safety and efficacy have not been studied in patients co-infected with HCV and HBV. (8.9)
Pediatrics: Safety and efficacy have not been studied in pediatric patients. (8.4)
Ribavirin Pregnancy Registry available. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 05/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1VICTRELIS Combination Therapy: Patients Without Cirrhosis Who Are Previously Untreated or Who Are Previous Partial Responders or Relapsers to Interferon and Ribavirin Therapy
2.2VICTRELIS Combination Therapy: Patients with Cirrhosis
2.3 Dose Modification
2.4Discontinuation of Dosing Based on Treatment Futility
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1Pregnancy (Use with Ribavirin and Peginterferon Alfa)
5.2Anemia (Use with Ribavirin and Peginterferon Alfa)
5.3Neutropenia (Use with Ribavirin and Peginterferon Alfa)
5.4Drug Interactions
5.5Laboratory Tests
6 ADVERSE REACTIONS
6.1Clinical Trials Experience
7 DRUG INTERACTIONS
7.1Potential for VICTRELIS to Affect Other Drugs
7.2Potential for Other Drugs to Affect VICTRELIS
7.3Established and Other Potential Significant Drug Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6Renal Impairment
8.7Hepatic Impairment
8.8Human Immunodeficiency Virus (HIV) Co-Infection
8.9Hepatitis B Virus (HBV) Co-Infection
8.10Organ Transplantation
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
12.5Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied
16.2Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1Pregnancy
17.2Anemia
17.3Neutropenia
17.4Usage Safeguards
17.5Missed VICTRELIS Doses
17.6Hepatitis C Virus Transmission
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
VICTRELIS™ (boceprevir) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy [see Clinical Studies (14)].
The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
VICTRELIS in combination with peginterferon alfa and ribaviri |
