HOVID TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLET 300MG [SIN16566P]

Product Info

HOVID TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLET 300MG

[SIN16566P]

Indication

INDICATION
HIV-1 infection
Hovid Tenofovir Disoproxil Fumarate Tablets is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older.

The following points should be considered when initiating therapy with Hovid Tenofovir Disoproxil Fumarate Tablets for the treatment of HIV-1 infection.

Hovid Tenofovir Disoproxil Fumarate Tablets should not be used in combination with other products containing Tenofovir disoproxil fumarate OR Tenofovir alafenamide (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Chronic Hepatitis B
Hovid Tenofovir Disoproxil Fumarate Tablets is indicated for the treatment of chronic hepatitis B in adults.

The following points should be considered when initiating therapy with Hovid Tenofovir Disoproxil Fumarate Tablets for the treatment of HBV infection:

• This indication is based primary on 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.

• Tenofovir disoproxil was evaluated in a limited number of patients with chronic hepatitis B and decompensated liver disease.

• The numbers of patients who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy.

Dosing

DOSAGE & ADMINISTRATION
Testing Prior to Initiation of Tenofovir disoproxil for Treatment of HIV-1 Infection or Chronic Hepatitis B
Prior to or when initiating Tenofovir disoproxil, test patients for HBV infection and HIV-1 infection. Tenofovir disoproxil alone should not be used in patients with HIV-1 infection [see Warnings and Precautions – 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, 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Recommended Tablet Dosage in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)
The recommended dosage of Tenofovir disoproxil 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 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.

Dosage Adjustment in Patients with Renal Impairment
Significantly increased drug exposures occurred when Tenofovir Disoproxil was administered to patients with moderate to severe renal impairment. Therefore, the dosing interval of Tenofovir Disoproxil should be adjusted in patients with baseline creatinine clearance <50mL/min using the recommendations provided in the table below:

These dosing interval recommendations are based on modelling of single-dose pharmacokinetic data in non-HIV and non- HBV infected patients 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.

No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min) Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients with mild renal impairment.

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.

Geriatric Patients
Clinical trials of Tenofovir disoproxil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Contraindications

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients in Hovid Tenofovir Disoproxil Fumarate.