Tenofovir Alafenamide Fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
The recommended dosage of Tenofovir Alafenamide Fumarate is 25 mg (one tablet) taken orally once daily with food.
No dosage adjustment is required in patients with mild, moderate, or severe renal impairment. However, Tenofovir Alafenamide Fumarate is not recommended for patients with end-stage renal disease (estimated creatinine clearance below 15 mL/min).
No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh A). However, Tenofovir Alafenamide Fumarate is not recommended for patients with decompensated hepatic impairment (Child-Pugh B or C).
Due to the risk of developing HIV-1 resistance, Tenofovir Alafenamide Fumarate alone is not recommended for the treatment of HIV-1 infection
Tenofovir Alafenamide Fumarate alone should not be used in patients with HIV infection.
Lactic acidosis and severe hepatomegaly with steatosis have been reported with the use of nucleoside analogs.
Discontinuation of anti-hepatitis B therapy, including Tenofovir Alafenamide Fumarate, may result in severe acute exacerbations of hepatitis B. Patients who discontinue Tenofovir Alafenamide Fumarate should be closely monitored with both clinical and laboratory follow-ups for at least several months after stopping treatment.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate in combination with other antiretrovirals. The majority of these cases have occurred in women.
The safety and effectiveness of Tenofovir Alafenamide Fumarate in pediatric patients under 18 years of age have not been established.
It is not known whether Tenofovir Alafenamide Fumarate and its metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tenofovir Alafenamide Fumarate and any potential adverse effects on the breastfed infant.
Drugs that induce P-gp activity are expected to decrease the absorption of Tenofovir Alafenamide Fumarate, resulting in decreased plasma concentrations, which may lead to loss of therapeutic effect.
Based on drug interaction studies conducted with Tenofovir Alafenamide Fumarate, no clinically significant drug interactions have been observed with ethinyl estradiol, itraconazole, ketoconazole, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, and sofosbuvir/velpatasvir.
If an overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdosage with Tenofovir Alafenamide Fumarate consists of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
