FDA notice about drug interactions with etravirine (Intelence)

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 summarised 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 etravirine, 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 etravirine. Alternative to clopidogrel should be considered.

Please also refer to the full lable available online (Intelence):

PDF link:  (PDF)

Links to other websites are current at date of posting but not maintained.