Emtricitabinedosage

Testing: Prior to or when initiating EMTRIVA test for hepatitis B virus infection. EMTRIVA may be taken without regard to food. Adult Patients (18 years of age and older): EMTRIVA capsules: One 200 mg capsule administered once daily orally.

EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally. Pediatric Patients (0–3 months of age): EMTRIVA oral solution: 3 mg/kg administered once daily orally. Pediatric Patients (3 months through 17 years of age): EMTRIVA capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally. Dose interval adjustment in adult patients with renal impairment: Creatinine Clearance (mL/min) Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours Oral Solution (10 mg/mL) 240 mg every 24 hours (24 mL) 120 mg every 24 hours (12 mL) 80 mg every 24 hours (8 mL) 60 mg every 24 hours (6 mL)

2.1 Testing

Prior to Initiation of Treatment with EMTRIVA Prior to or when initiating EMTRIVA, test patients for hepatitis B virus infection.

2.2 Recommended

Dosage EMTRIVA is taken by mouth once daily and may be taken without regard to food.

2.3 Recommended

Dosage in Adult Patients (18 years of age and older) EMTRIVA capsules: One 200 mg capsule administered once daily orally.

EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.

2.4 Recommended

Dosage in Pediatric Patients (0–3 months of age) EMTRIVA oral solution: 3 mg per kg administered once daily orally.

2.5 Recommended

Dosage in Pediatric Patients (3 months through 17 years of age) EMTRIVA oral solution: 6 mg per kg up to a maximum of 240 mg (24 mL) administered once daily orally.

EMTRIVA capsules: For pediatric patients weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

2.6 Dosage Adjustment in

Patients with Renal Impairment Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of dose adjustment recommendations in patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients. Table 1 Dose Interval Adjustment for Adult Patients with Altered Creatinine Clearance Creatinine Clearance (mL/min) Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours Oral Solution (10 mg/mL) 240 mg every 24 hours (24 mL) 120 mg every 24 hours (12 mL) 80 mg every 24 hours (8 mL) 60 mg every 24 hours (6 mL) There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.