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Adefovir

    Brands

    DEA Class; Rx

    Common Brand Names; adefovir dipivoxil, Hepsera

    • Hepatitis B/Hepatitis C Agents; 
    • Hepatitis B, NRTIs

    Acyclic nucleotide analog
    For the treatment of chronic hepatitis B virus (HBV) infections in patients 12 years and older
    Black Box Warnings for: nephrotoxicity; severe acute exacerbations of hepatitis; HIV resistance; lactic acidosis and severe hepatomegaly with steatosis

    Indicated for the treatment of chronic hepatitis B infection.

    Hypersensitivity

    Concurrent use with products containing tenofovir disoproxil fumarate or tenofovir alafenamide

    • Hematuria (11% vs 10% in placebo-treated)
    • Asthenia (13% vs. 14% placebo)
    • Hepatitis exacerbation (25%)
    • Nausea (5%)
    • Flatulence (4%)
    • Diarrhea (3%)
    • Dyspepsia (3%)
    • Headache (9%)
    • Rash (1-10%)
    • Pruritus (1-10%)
    • Dyspepsia (5-9%)
    • Cough (6-8%)
    • Rhinitis (5%)
    • Increased AST/ALT
    • Abnormal liver function
    • Renal failure
    • Renal insufficiency
    • Increased serum Cr (2-3%)
    • Hypophosphatemia

    Discontinuation may result in severe acute exacerbation of hepatitis B

    Patients who discontinue treatment: Monitor hepatic function for several months

    Patients with renal dysfunction: Risk of nephrotoxicity (monitor and adjust dose accordingly)

    Coadministration with drugs that reduce renal function may increase adefovir serum concentration

    Do not administer with tenofovir (additive toxicity)

    May increase HIV resistance in untreated patients who are HIV+

    Risk of lactic acidosis, severe hepatomegaly with steatosis

    There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed during pregnancy

    It is not known whether adefovir is present in human breast milk, affects human milk production, or has effects on breastfed infant

    Adults

    10 mg/day PO.

    Geriatric

    10 mg/day PO.

    Adolescents

    10 mg/day PO.

    Children

    12 years: 10 mg/day PO.
    7 to 11 years: Safety and efficacy have not been established; doses up to 0.25 mg/kg/day (maximum 10 mg/day) PO have been used off-label for the treatment of chronic hepatitis B infection.
    2 to 6 years: Safety and efficacy have not been established; doses up to 0.3 mg/kg/day PO have been used off-label for the treatment of chronic hepatitis B infection.
    Younger than 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Adefovir dipivoxil

    tablet

    • 10mg