Tenofovir disoproxil fumarate

Visa No.: VD-20041-13

Product: Tenofovir 300

API: Tenofovir disoproxil fumarat

Product Category: Antiviral

Version approved leaflet: 833/QĐ-QLD_21/12/2022_181

INDICATIONS

HIV-1 infection:
In combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adults and paediatric patients aged 2 years and older.
Chronic hepatitis B: 
Treatment of chronic hepatitis B in adults and adolescents aged 12 years and older.
 

DOSAGE AND ADMINISTRATION

Dosage: 
Adults and adolescents ≥12 years of age (body weight ≥35 kg):
The recommended dose for the treatment of HIV-1 infection or chronic hepatitis B is one Tenofovir disoproxil fumarate 300 mg tablet once daily, taken with or without food. In the treatment of chronic hepatitis B, the optimal treatment duration has not yet been established.
Safety and efficacy have not been established in pediatric patients with chronic hepatitis B weighing less than 35 kg.
Pediatric patients from 2 years to <12 years of age
HIV-1 infection:
For pediatric patients aged ≥2 years, the recommended oral dose of tenofovir disoproxil fumarate is 8 mg/kg body weight once daily (maximum dose: 300 mg/day).
Tenofovir disoproxil fumarate dosing recommendations based on body weight are provided in Table 1. Body weight should be monitored periodically and the dose adjusted accordingly.
Table 1. Recommended Tenofovir disoproxil fumarate dose for pediatric patients ≥2 years of age and body weight ≥17 kg

Chronic Hepatitis B (Pediatric Use):
The safety and efficacy of tenofovir disoproxil fumarate in pediatric patients with chronic hepatitis B under 12 years of age have not been established.

Dosage Adjustment in Adult Patients with Renal Impairment:
Tenofovir blood concentrations increase significantly in patients with moderate to severe renal impairment. Therefore, the dosing interval of tenofovir disoproxil fumarate should be adjusted in patients with creatinine clearance <50 mL/min (see recommendations in Table 2).
The safety and efficacy 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 dose adjustment is required for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of creatinine clearance, serum phosphate, urine glucose, and urine protein should be performed in patients with mild renal impairment.

Table 2. Recommended dosing interval adjustment for patients with renal impairment

ᵃ Calculated using ideal body weight.
ᵇ Generally corresponds to once weekly, assuming three dialysis sessions per week of approximately 4 hours each. Tenofovir disoproxil fumarate should be administered after completion of dialysis.
Tenofovir pharmacokinetics have not been evaluated in patients not undergoing hemodialysis with creatinine clearance <10 mL/min; therefore, no dosing recommendation can be made for these patients.
Pediatric use: No dosing recommendation is available for pediatric patients with renal impairment.

Method of administration
Tenofovir disoproxil fumarate 300 mg tablet should be taken once daily, with or without food.

CONTRAINDICATIONS

Hypersensitivity to tenofovir disoproxil fumarate or to any of the excipients.

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.