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

March 11, 2010

FDA recently updated 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.

Please also refer to www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf to view the complete updated label.

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.

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




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