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Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
Date:10/17/2007

ns containing efavirenz. Nervous system symptoms are not predictive of the less frequent psychiatric symptoms.

It is recommended that creatinine clearance (CrCl) be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with ATRIPLA, and routine monitoring of CrCl and serum phosphorous be performed for patients at risk of renal impairment. ATRIPLA should not be given to patients with CrCl <50 mL/min. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir DF. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent.

ATRIPLA may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breast-feed while taking ATRIPLA. Barrier contraception must always be used in combination with other methods of contraception (e.g., oral or other hormonal contraceptives). If the patient becomes pregnant while taking ATRIPLA, she should be apprised of the potential harm to the fetus.

Mild-to-moderate rash is a common side effect of efavirenz. In controlled clinical trials, 26% of patients treated with efavirenz experienced new-onset skin rash compared with 17% of patients treated in control groups. ATRIPLA should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Skin discoloration, associated with emtricitabine, may also occur.

Liver enzymes should be monitored in patients with known or suspected hepatitis B or C and when ATRIPLA is administered with ritonavir or other medications associated with liver toxicity.

Decreases in bone mineral density (BMD) have been seen with tenofovir DF. Cases of osteomalacia (associated with proximal renal tubulopathy) have been reported in association with the use of tenofovir DF.

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SOURCE Bristol-Myers Squibb Company
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