VIRCLEAN F.C. TABLETS 300MG [SIN16078P]

Product Info

VIRCLEAN F.C. TABLETS 300MG

[SIN16078P]

1 INDICATIONS AND USAGE

1.1 HIV-1 Infection
VIRCLEAN is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The following points should be considered when initiating therapy with VIRCLEAN for the treatment of HIV-1 infection:

• VIRCLEAN should not be used in combination with DESCOVY ® , GENVOYA ® , STRIBILD ® , TRUVADA ® or other products containing Tenofovir Disoproxil Fumarate or Tenofovir alafenamide [See Warnings and Precautions (5.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

1.2 Chronic Hepatitis B
VIRCLEAN is indicated for the treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with Tenofovir Disoproxil Fumarate for the treatment of chronic hepatitis B infection:

• The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (13.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

• Tenofovir Disoproxil Fumarate was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. [See Adverse Reactions (6.1), Clinical Studies (13.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

• The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (11.3), Clinical Studies (13.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Tenofovir Disoproxil Fumarate is indicated for the treatment of chronic hepatitis B in adolescents 12 to <18 years of age with:

• Compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

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.

4 CONTRAINDICATIONS

None.