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 2 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
-- The most common adverse events (>10 percent) of any intensity that
occurred at a higher rate than placebo at 24-weeks 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 patients receiving an INTELENCE-containing regimen vs.
placebo at 24-weeks were rash (9.0 percent vs. 3.1 percent), diarrhea
(5.2 percent vs. 9.6 percent), nausea (4.7 percent vs. 3.5 percent),
fatigue (3.3 percent vs. 4.0 percent), abdominal pain (3.0 percent vs.
2.5 percent), peripheral neuropathy (2.8 percent vs. 1.8 percent),
hypertension (2.8 percent vs. 2.2 percent), headache (2.7 percent vs.
4.1 percent), and vomiting (2.3 percent vs. 2.0 percent).
-- INTELENCE should not be co-administered with the following ARVs:
tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/riton
|SOURCE Tibotec Therapeutics|
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