Etravirine

Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older. Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older.

Etravirine is an antiretroviral drug.

Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. Pregnant patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. Pediatric patients (2 years to less than 18 years of age and weighing at least 10 kg): dosage of Etravirine is based on body weight and should not exceed the recommended adult dose. Etravirine tablets should be taken following a meal.

None. None.

Severe, potentially life threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases closely. Monitor for immune reconstitution syndrome and fat redistribution.

The following adverse reactions are described in greater detail in other sections: Severe skin and hypersensitivity reactions. Immune reconstitution syndrome. The most common adverse drug reactions of moderate to severe intensity (at least 2%) which occurred at a higher rate than placebo in adults are rash and peripheral neuropathy. The most common adverse drug reactions in at least 2% of pediatric patients are rash and diarrhea.

Co-administration of Etravirine with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of etravirine. The potential drug-drug interactions must be considered prior to and during therapy.

Store Etravirine tablets at 25°C (77°F), with excursions permitted to 15° to 30°C (59° to 86°F). Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture.