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Press Release

Prezista (Darunavir) Label Update

June 1, 2012

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 is available at Drugs@FDA.



  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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