Simeprevir contraindications

Simeprevir
OLYSIO® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
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 OLYSIO combination treatment with peginterferon alfa and ribavirin.

OLYSIO in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in 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)].

Refer to the respective prescribing information for a list of the contraindications for peginterferon alfa andribavirin.

References

Adapted from the FDA Package Insert.