Adefovir dipivoxil

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 is an antiviral drug.

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.

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

Boxed warning: Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis B therapy may be warranted. 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.

The following adverse reactions are discussed in other sections of the labeling: Severe acute exacerbations of Hepatitis [ S ee Boxed Warning, Warnings and Precautions ] Nephrotoxicity Most common adverse reaction (incidence greater than 5%) in compensated liver disease patients were asthenia, headache, abdominal pain and nausea. The most common adverse reaction in pre- and post- transplantation lamivudine-resistant liver disease patients was increased creatinine.

Since adefovir is eliminated by the kidney, coadministration of adefovir dipivoxil with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either adefovir and/or these coadministered drugs. Patients should be monitored closely for adverse events when adefovir dipivoxil is coadministered with drugs that are excreted renally or with other drugs known to affect renal function. Adefovir dipivoxil should not be administered in combination with VIREAD. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of adefovir or the coadministered drug. Monitor for adefovir dipivoxil associated adverse events.

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).