Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Victrelis (boceprevir) label changes update contraindications and drug interactions

On January 17, 2014, FDA approved changes to the Victrelis (boceprevir) package insert to expand the list of contraindicated medications and update the Drug Interaction section.

Doxazosin, silodosin and tamsulosin, alpha 1-adrenoreceptor antagonists, were added to the section 4 Contraindications due to the potential for alpha 1-adrenoreceptor antagonist-associated adverse events such as hypotension and priapism.

In section 7 Drug Interactions the calcium channel blockers, amlodipine, dilitiazem, nisoldipine and verapamil were added.

The complete, revised label will be posted soon to the Drugs@FDA, and DailyMed sites.

Victrelis is a product of Merck & Co.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration