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FDA Updates Etravirine (Intelence) Label with Additional Information on Drug Interactions

SUMMARY: The U.S. Food and Drug Administration (FDA) last week announced that the product label for the next-generation NNRTI etravirine (Intelence) has been updated to include new information about drug-drug interactions with the boosted protease inhibitor lopinavir/ritonavir (Kaletra), the antifungal agents fluconazole (Diflucan) and voriconazole (VFEND), and the anti-clotting medication clopidogrel (Plavix).

Below is the text of the recent FDA press release describing the changes.

Intelence (Etravirine) Label Revised to Include New Drug-Drug Interaction Information

FDA recently updated the Intelence (etravirine) label to include drug-drug interaction information between etravirine and fluconazole, voriconazole, lopinavir/ritonavir tablets and clopidogrel. The major changes to Section 7 Drug Interactions are summarized below.

In addition the magnitude of the interaction for etravirine in the presence of fluconazole, voriconazole and lopinavir/ritonavir tablets can be found in section 12.3 Pharmacokinetics.

Etravirine - fluconazole and voriconazole: Co-administration of etravirine and fluconazole or voriconazole significantly increased etravirine exposures. The amount of safety data at these increased etravirine exposures is limited; therefore, etravirine and fluconazole or voriconazole should be co-adminstered with caution. No dose adjustments of Intelence, fluconazole or voriconazole is needed.

Etravirine - lopinavir/ritonavir tablets: Intelence and Kaletra (lopinavir/ritonavir) tablets can be co-administered without dose adjustment

Etravirine - clopidogrel: Activation of clopidogrel to its active metabolite may be decreased when clopidogrel is co-administered with Intelence. Alternative to clopidogrel should be considered.

Please refer to http://www.accessdata.fda to view the complete updated label.

Etravirine is a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) made by Tibotec Therapeutics.



R Klein and K Struble (Food and Drug Administration). Intelence (Etravirine) Label Revised to Include New Drug-Drug Interaction Information. HIV/AIDS Update. March 11, 2010.

Food and Drug Administration. Intelence (etravirine) label revised to include new drug-drug interaction information. Press release. March 11, 2010.
















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