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European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
Date:12/17/2007

Use ATRIPLA with caution in patients with a history of seizures. Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.

Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg).

Saquinavir should not be used as the only protease inhibitor in combination with ATRIPLA.

Coadministration of ATRIPLA and atazanavir is not recommended due to concerns regarding decreased atazanavir concentrations. Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations. Patients on atazanavir or lopinavir/ritonavir plus ATRIPLA should be monitored for tenofovir-associated adverse events. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse events.

Coadministration of ATRIPLA with didanosine should be undertaken with caution. Patients receiving this combination should be monitored closely for didanosine-associated adverse events. See Full Prescribing Information for complete list of drug-drug interactions.

In Study 934, the most frequently reported grades 2-4 adverse events through 48 weeks in patients receiving efavirenz + emtricitabine + tenofovir DF were dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%).

The dose of ATRIPLA is one tablet (containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF) once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. ATRIPLA is not recommended for use in patients <18 years of age.

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SOURCE Bristol-Myers Squibb Company
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