Classes
DEA Class; Rx
Common Brand Names; adefovir dipivoxil, Hepsera
- Hepatitis B/Hepatitis C Agents;
- Hepatitis B, NRTIs
Description
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
Indications
Indicated for the treatment of chronic hepatitis B infection.
Contraindications
Hypersensitivity
Concurrent use with products containing tenofovir disoproxil fumarate or tenofovir alafenamide
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
10 mg/day PO.
10 mg/day PO.
10 mg/day PO.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Adefovir dipivoxil
tablet
- 10mg
