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Indications:

This medicine is a nucleotide analogue indicated for the treatment of chronic hepatitis B in patients ≥12 years of age.

Contraindications:

This medicine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Adverse reactions:

Most common adverse reaction (>10%) in compensated disease patients is asthenia and in pre- and post-transplantation lamivudineresistant liver disease patients is increased creatinine.

Interactions:

Co-administration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of adefovir or the co-administered drug. Monitor for this medicine associated adverse events.

Warnings:

• Severe acute exacerbations of hepatitis: Monitor hepatic function closely at repeated intervals for at least several months in patients who discontinue this medicine. • 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 this medicine. Untreated HIV may result in HIV resistance. • Lactic acidosis and severe hepatomegaly with steatosis: If suspected, suspend treatment. • Coadministration with Other Products: Do not administer this medicine concurrently with VIREAD or other tenofovircontaining products. • Clinical Resistance: For patients with lamivudine-resistant HBV use adefovir dipivoxil in combination with lamivudine. For all patients, consider modifying treatment in case serum HBV DNA remains above 1000 copies/mL with continued treatment.

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