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.
-- INTELENCE should not be co-administered with the following ARVs:
tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonaviPage: 1 2 3 4 5 6 7 8 Related biology technology :1
. FDA Approves Additional Dosage Strengths of Shires ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients2
. FDA Approves New Mechanism of Action Labeling for Ranexa(R)3
. FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children4
. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)5
. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML6
. FDA Approves Genzymes Renvela(TM) for Dialysis Patients7
. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer8
. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections9
. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir10
. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)11
. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia