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U.S. Department of Health and Human Services

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Viracept (nelfinavir) Label change reflects drug-drug interaction information with warfarin

On February 24, 2011, FDA updated the Viracept (nelfinavir) label to include drug-drug interaction information between nelfinavir and wafarin.

Table 11 (Established and Other Potentially Significant Drug Interactions) of the Precautions section of the label was changed to add the following:

Coadministration of wafarin and Viracept may affect concentrations of wafarin. It is recommended that the INR (international normalized ratio) be monitored carefully during treatment with Viracept, especially when commencing therapy.

The complete, revised label will be posted soon at Drugs@FDA

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration