January 22, 2014

FDA Hepatitis Update - Victrelis (boceprevir) label changes update contraindications

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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 4Contraindications 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

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