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 [see Warnings and Precautions (5.1)].

​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 [see Warnings and Precautions (5.2)].

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 [see Use in Specific Population (8.6)].