Emtricitabine/Tenofovir DF/Efavirenz

QTc prolongation reported with use of efavirenz; consider alternatives when coadministered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes

(All NRTIs): Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in absence of marked transaminase elevations)

Do not coadminister with drugs containing emtricitabine, tenofovir, lamivudine, or efavirenz

Rash may occur; therapy can be reinitiated in patients interrupting therapy because of rash; treatment should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever; appropriate antihistamines and/or corticosteroids may improve tolerability and hasten resolution of rash; for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome), alternative therapy should be considered; discontinue therapy if severe rash develops

Increased risk of renal impairment; estimate CrCl in all patients before initiating and avoid concurrent or recent use of nephrotoxic drugs; renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with use of TDF, a component of the combination drug; prior to initiation and during use of combination drug, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients; in patients with chronic kidney disease, also assess serum phosphorus; therapy is not recommended in patients with moderate or severe renal impairment (estimated creatinine clearance below 50 mL/min); persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in patients at risk of renal dysfunction; discontinue therapy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome

Use caution in history of hepatitis B or C