Boceprevir contraindications

Boceprevir
VICTRELIS® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Contraindications

Contraindications to peginterferon alfa and ribavirin also apply to VICTRELIS combination treatment.

VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in:

Pregnant women and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Patients with a history of a hypersensitivity reaction to boceprevir [see Warnings and Precautions (5.4)].

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, including those in Table 2, is contraindicated [see also Drug Interactions (7)].

Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy, including those inTable 2, is contraindicated [see also Drug Interactions (7)].

References

Adapted from the FDA Package Insert.