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Boceprevir contraindications

Introduction

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
Contraindications

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)].

[1]

References

References

Adapted from the FDA Package Insert.

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