Temixys Dosage

2.1 Testing Prior to Initiation and During Treatment with TEMIXYS

Prior to initiation treatment with TEMIXYS, test patients for hepatitis B virus infection.

​Prior to initiation and during use of TEMIXYS, 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.

Recommended Dose for Adult and Pediatric Patients Weighing at Least 35 kg

TEMIXYS is a two-drug fixed-dose combination product containing 300 mg of lamivudine (3TC) and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of TEMIXYS in HIV-1 infected adult and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with or without food.

Not Recommended in Renal Impairment

Because TEMIXYS is a fixed-dose combination formulation and cannot be dose adjusted, it is not recommended for patients with impaired renal function (creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis.