FDA Updates Darunavir (Prezista) Labeling

“On April 7, 2014, FDA approved new changes to the Prezista (darunavir) label to update the following sections: “WARNING AND PRECAUTIONS, Severe Skin Reactions,  ADVERSE REACTIONS, Postmarketing Experience, and PATIENT COUNSELING INFORMATION sections of the labeling were updated with information regarding rash with eosinophilia and systemic symptoms. “DRUG INTERACTIONS, Established and Other Potentially Significant Drug Interaction and CLINICAL PHARMACOLOGY, Table 15 subsections of the labeling were updated with information regarding dolutegravir. … “CLINICAL PHARMACOLOGY, Microbiology subsection of labeling was updated to rilipivirine to the list of drugs that did not show antagonism with darunavir.  “Prezista 400 mg tablets were removed from the HOW SUPPLIED/STORAGE AND HANDLING section because this dosage strength is no longer marketed in the US.” The revised label is available at the FDA website. More information is available: FDA: Press release AIDSinfo: Darunavir (Prezista) patient fact sheet