FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati... (f any intensity that occurred at a highe...)

FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy

Date:1/18/2008

f any intensity that occurred at a higher rate than placebo were rash (16.9 percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1 percent). The most common treatment-emergent adverse reactions (Grade 2-4) that occurred in greater than or equal to two percent of patients receiving an INTELENCE-containing regimen were diarrhea, nausea, abdominal pain, vomiting, fatigue, peripheral neuropathy, headache, rash, and hypertension.

Additional Important Safety Information

INTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

-- Severe and potentially life-threatening skin reactions, including

Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema

multiforme, have occurred (< 0.1 percent) in patients taking INTELENCE.

Treatment with INTELENCE should be discontinued and appropriate therapy

initiated if severe rash develops.

-- In general, in clinical trials, rash was mild to moderate, occurred

primarily in the second week of therapy, and was infrequent after Week

4. Rash generally resolved within 1-2 weeks on continued therapy.

Discontinuation rate due to rash was two percent.

-- Redistribution and/or accumulation of body fat have been observed in

patients receiving antiretroviral (ARV) therapy. The causal

relationship, mechanism, and long-term consequences of these events

have not been established.

-- Immune reconstitution syndrome has been reported in patients treated

with ARV therapy, including INTELENCE.

-- INTELENCE should be used with caution in patients with severe hepatic

impairment (Child-Pugh class C) as pharmacokinetics of INTELENCE have

not been evaluated in these patients.

Drug Interactions

-- INTELENCE should not be co-administered with the following ARVs:

tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavi
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FDA Approves INTELENCE(TM) (etravirine) for HIV Combinati...(f any intensity that occurred at a highe...)