HIV/AIDS Update - Labeling update for Isentress (raltegravir)

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On April 8, 2014 FDA approved updates to the Isentress (raltegravir) label to include information regarding co-adminsitration of raltegravir with boceprevir or telaprevir.

In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of telaprevir or boceprevir. No dose adjustment is required for Isentress or boceprevir or telaprevir.

The complete revised label can be viewed at Drugs@FDA.

Isentress is an HIV integrase strand transfer inhibitor, manufactured by Merck & Co., Inc.

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

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

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