Description
Description
TEFOD 25mg Tablet contains tenofovir alafenamide (TAF), a nucleotide reverse transcriptase inhibitor (NRTI) used to treat chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. TAF is a prodrug of tenofovir that, once inside hepatocytes, is converted to the active metabolite tenofovir diphosphate. This metabolite inhibits HBV replication by incorporating into viral DNA, leading to DNA chain termination.
Mechanism of Action
After oral administration, TAF is absorbed and enters hepatocytes via transporters OATP1B1 and OATP1B3. Within these cells, TAF is hydrolyzed to tenofovir by carboxylesterase 1 (CES1). Tenofovir is then phosphorylated to tenofovir diphosphate, which inhibits HBV reverse transcriptase, resulting in the termination of viral DNA elongation.
Dosage and Administration
The recommended dosage for adults and adolescents aged 12 years and older weighing at least 35 kg is 25 mg once daily, taken with food. The tablet should be swallowed whole and not crushed, broken, or chewed.
Side Effects
Common side effects may include headache, nausea, fatigue, cough, and abdominal discomfort. Serious adverse effects can involve renal impairment, lactic acidosis, and hepatomegaly with steatosis. Regular monitoring of renal function and liver enzymes is recommended during treatment.
Drug Interactions
TAF is a substrate of P-glycoprotein (P-gp) and BCRP. Co-administration with strong P-gp or BCRP inhibitors may increase TAF plasma concentrations, while inducers may decrease its efficacy. Concomitant use with other tenofovir-containing products is contraindicated.
Precautions
Discontinuation of TAF therapy may lead to acute exacerbations of hepatitis B. Patients should be monitored for signs of HBV reactivation after stopping treatment. TAF is not recommended for use in patients with decompensated cirrhosis or severe renal impairment (creatinine clearance <15 mL/min) .
Storage
Store TEFOD tablets in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
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