Adefovir Dipivoxil

What it is and how it works

Mechanism of Action Adefovir is an antiviral drug .

Indications

Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function. Adefovir dipivoxil tablets are a nucleotide analogue indicated for the treatment of chronic hepatitis B in patients 12 years of age and older.

Dosage and administration (summary)

One tablet containing 10 mg adefovir dipivoxil once daily orally with or without food. Dose adjustment in renal impairment for adults Creatinine Clearance (mL/min) Creatinine clearance calculated by Cockcroft-Gault method using lean or ideal body weight. Greater than or equal to 50 30 to 49 10 to 29 Hemodialysis Patients Recommended dose and dosing interval 10 mg every 24 hours 10 mg every 48 hours 10 mg every 72 hours 10 mg every 7 days following dialysis No dose recommendations for : Non-hemodialysis patients with creatinine clearance less than 10 mL per minute. Adolescent patients with renal impairment.

Contraindications

Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. Adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Warnings and precautions

Severe acute exacerbations of hepatitis: Monitor hepatic function closely at repeated intervals for at least several months in patients who discontinue adefovir dipivoxil. Nephrotoxicity: Monitor renal function during therapy for all patients, particularly those with pre-existing or other risks for renal impairment. Dose adjustment may be required. HIV Resistance: Offer HIV testing to all patients prior to initiating adefovir dipivoxil. Untreated HIV may result in HIV resistance. Lactic acidosis and severe hepatomegaly with steatosis: If suspected, suspend treatment.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adefovir dipivoxil during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263.

Storage and supply

Store in original container at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) . Do not use if seal over bottle opening is broken or missing.

Source: Adefovir Dipivoxil (Adefovir Dipivoxil) — US FDA prescribing information, 2025-07-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.