FDA OKs label update for etravirine

January 20, 2011

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral (ARV) agents.

The recommended oral dose of etravirine tablets is 200 mg (one 200-mg tablet or two 100-mg tablets) taken twice a day following a meal. The new 200-mg product formulation is expected to launch in the United States sometime this month. The 100-mg tablet will remain available.

Patients who are unable to swallow etravirine tablets whole may disperse the tablets in a glass of water.