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U.S. Department of Health and Human Services

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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 additon 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 coadministered 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.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf to view the complete updated label.

Etravirine is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) made by Tibotec Therapeutics.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration