Viread Tablets 300mg

GILEAD SCIENCES SINGAPORE PTE. LTD.

GILEAD SCIENCES SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Testing Prior to Initiation of VIREAD for Treatment of HIV-1 Infection or Chronic Hepatitis B** Prior to or when initiating VIREAD, test patients for HBV infection and HIV-1 infection. VIREAD alone should not be used in patients with HIV-1 infection _\[see Warnings and Precautions (5.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Prior to initiation and during use of VIREAD, 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 _\[see Warnings and Precautions (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.2 Recommended Tablet Dosage in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)** The recommended dosage of VIREAD in adults and pediatric patients weighing at least 35 kg is one 300 mg tablet taken orally, once daily without regard to food. The dosage for VIREAD is the same for both HIV and HBV indications. In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. Safety and efficacy in pediatric patients with chronic hepatitis B weighing less than 35 kg have not been established. **2.3 Dosage Adjustment in Patients with Renal Impairment** Significant increase in drug exposures occurred when VIREAD was administered to subjects with moderate to severe renal impairment (creatinine clearance below 50 mL/min). 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) _\[see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (11.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.  No data are available to make dosage recommendations in patients with creatinine clearance below 10 mL/min who are not on hemodialysis. No data are available to make dosage recommendations in pediatric patients 12 years of age and older with renal impairment.