HIV/AIDS Update -Prezista (darunavir) label update

Updates to the Prezista (darunavir) package insert were approved on June 1, 2012 and include the following:

• Addition of acute generalized exanthematous pustulosis (an acute skin eruption of characterized by numerous small, sterile pustules) to the WARNINGS and PRECAUTIONS, Severe Skin Reaction and ADVERSE REACTIONS, Postmarketing Experience sections

• Revisions to DRUG INTERACTIONS, Established and Other Potentially Significant Drug Interactions and CLINICAL PHARMACOLOGY, Pharmacokinetics sections to include boceprevir drug-drug interaction information. Specifically, Concomitant administration of Prezista/ritonavir and boceprevir resulted in reduced steady-state exposures to darunavir and boceprevir. It is not recommended to co-administer boceprevir and Prezista/ritonav

The full updated labeling will be posted soon at Drugs@FDA

Prezista is an HIV-1 protease inhibitor manufactured for Janssen Therapeutics

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration