VIRCLEAN F.C. TABLETS 300MG

NOVEM HEALTHCARE PTE LTD

NOVEM HEALTHCARE PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Testing Prior to Initiation of Tenofovir Disoproxil Fumarate for Treatment of HIV-1 Infection or Chronic Hepatitis B** Prior to or when initiating Tenofovir Disoproxil Fumarate, test patients for HBV infection and HIV-1 infection. Tenofovir Disoproxil Fumarate 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 Tenofovir Disoproxil Fumarate, 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 Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)** For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIRCLEAN tablet once daily taken orally, without regard to food. 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 Dose Adjustment for Renal Impairment in Adults** Significantly increased drug exposures occurred when Tenofovir Disoproxil Fumarate was administered to subjects with moderate to severe renal impairment \[See Clinical Pharmacology (11.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Therefore, the dosing interval of Tenofovir Disoproxil Fumarate should be adjusted in patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment; therefore, clinical response to treatment and renal function should be closely monitored in these patients \[See Warnings and Precautions (5.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in patients with mild renal impairment \[See Warnings and Precautions (5.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].  The pharmacokinetics of Tenofovir Disoproxil Fumarate have not been evaluated in non-hemodialysis patients with creatinine clearance below 10 mL/min; therefore, no dosing recommendation is available for these patients. No data are available to make dose recommendations in pediatric patients 12 years of age and older with renal impairment.