ovine) Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Benzodiazepines: midazolam, triazolam Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.
Calcium channel blocker: bepridil Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
GI motility agent: cisapride Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Neuroleptic: pimozide Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
St. John's wort (Hypericum perforatum) May lead to loss of virologic response and possible resistance to efavirenz or to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
WARNINGS AND PRECAUTIONS
Serious psychiatric symptoms: Immediate medical eva luation is recommended. (5.5, 6.1)
Nervous system symptoms (NSS): NSS are frequent, usually begin 1–2 days after initiating therapy and resolve in 2–4 weeks. Dosing at bedtime may improve tolerability. NSS are not predictive of onset of psychiatric symptoms. (2, 5.6)
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess creatinine clearance (CrCl) before initiating treatment with ATRIPLA. Monitor CrCl and serum phosphorus in patients at risk. Avoid administering ATRIPLA with concurrent or recent use of nephrotoxic drugs. (5.7)
Pregnancy: Fetal harm can occur when administered to a pregnant woman during the first trimester. Women should be apprised of the potential harm to the fetus. A pregnancy registry is available. (5.8, 8.1)
Rash: Discontinue if severe rash develops. (5.9, 6.1)
Hepatotoxicity: Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity. Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease. (5.10, 6.3, 8.6)
Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathological fracture or other risk factors for osteoporosis or bone loss. (5.11)
Convulsions: Use caution in patients with a history of seizures. (5.12)
Immune reconstitution syndrome: May necessitate further eva luation and treatment. (5.13)
Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. (5.14)
Coadministration with other products: Do not use with drugs containing emtricitabine or tenofovir disoproxil fumarate including COMPLERA, EMTRIVA, TRUVADA, or VIREAD; or with drugs containing lamivudine. SUSTIVA (efavirenz) should not be coadministered with ATRIPLA unless required for dose-adjustment when coadministered with rifampin. Do not administer in combination with HEPSERA. (5.4)
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs including tenofovir DF, a component of ATRIPLA, in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administ |
