ALBIVIR FILM-COATED TABLETS 300MG [SIN17328P]

Product Info

ALBIVIR FILM-COATED TABLETS 300MG

[SIN17328P]

Indication

1 INDICATIONS AND USAGE

1.1 HIV-1 Infection

Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older.

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

• Tenofovir disoproxil fumarate should not be used in combination with other products containing tenofovir disoproxil fumarate (DF) 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

Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and adolescents 12 to <18 years of age.

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.

Dosing

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 Tablet Dosage in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)

The recommended dosage of tenofovir disoproxil fumarate 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 tenofovir disoproxil fumarate 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 tenofovir disoproxil fumarate 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.

Contraindications

4 CONTRAINDICATIONS

None.