This drug is a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
Recommended dose in adults and pediatric patients (12 years of age and older and weighing at least 40 kg): One tablet once daily taken orally on an empty stomach, preferably at bedtime.
Dose in renal impairment: Should not be administered in patients with estimated creatinine clearance below 50 mL/min.
With rifampin co-administration, an additional 200 mg/day of efavirenz is recommended for patients weighing 50 kg or more.
Most common side effects of efavirenz, emtricitabine, and tenofovir DF are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
Serious psychiatric symptoms: Immediate medical evaluation is recommended.
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.
New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with this combination drug. In patients at risk for renal dysfunction, assess creatinine clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with Viraday and periodically during treatment. Avoid administering this combination medicine with concurrent or recent use of nephrotoxic drugs.
Pregnancy: Fetal harm may 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.
Rash: Discontinue if severe rash develops.
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