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U.S. Department of Health and Human Services

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Prezista (darunavir) label change - drug interaction information

The FDA recently approved changes to the Prezista (darunavir) label to reflect drug interaction information with artemether/lumefantrine. The specific changes are outlined below.

Section 7: Drug Interactions

Antimalarials: artemether/lumefantrine – No change in darunavir exposures. Decrease in artemether and dihydroartemisinin exposures. Increase in lumefantrine exposures. The combination of Prezista and artemether/lumefantrine can be used without dose adjustments. However, the combination should be used with caution as increased lumefantrine exposure may increase the risk of QT prolongation.

Section 12 Clinical Pharmacology was also updated to include these drug interactions.

You can view the complete, revised label at Drugs@FDA.

Prezista is a product of Janssen Pharmaceuticals.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Special Health Issues
Food and Drug Administration