Emtricitabinedosage

Testing: Prior to or when initiating COMPLERA, test for hepatitis B virus infection. Prior to initiation and during treatment with COMPLERA, 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 dosage in adults and pediatric patients weighing at least 35 kg: One tablet taken orally once daily with food. For pregnant patients who are already on COMPLERA prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet taken once daily may be continued. Lower exposures of rilpivirine were observed during pregnancy; therefore, viral load should be monitored closely.

Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. Recommended dosage with rifabutin coadministration: an additional 25 mg tablet of rilpivirine (Edurant) once per day taken concomitantly with COMPLERA and with a meal for the duration of the rifabutin coadministration.

2.1 Testing

Prior to Initiation and During Treatment with COMPLERA Prior to or when initiating COMPLERA, test patients for hepatitis B virus infection. Prior to initiation of COMPLERA, and during treatment with COMPLERA, 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.

2.2 Recommended

Dosage COMPLERA is a three-drug fixed dose combination product containing 200 mg of emtricitabine (FTC), 25 mg of rilpivirine (RPV), and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of COMPLERA in adult and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with food.

2.3 Recommended

Dosage During Pregnancy For pregnant patients who are already on COMPLERA prior to pregnancy and are virologically suppressed (HIV-1 RNA less than 50 copies per mL), one tablet of COMPLERA taken once daily may be continued. Lower exposures of rilpivirine, a component of COMPLERA, were observed during pregnancy, therefore viral load should be monitored closely.

2.4 Not Recommended in

Patients with Moderate or Severe Renal Impairment COMPLERA is not recommended in patients with moderate or severe renal impairment (estimated creatinine clearance below 50 mL per minute).

2.5 Recommended

Dosage with Rifabutin Coadministration If COMPLERA is coadministered with rifabutin, take an additional 25 mg tablet of rilpivirine (Edurant ® ) with COMPLERA once daily with a meal for the duration of the rifabutin coadministration.