HEPSERA Dosage & Rx Info | Uses, Side Effects

Hepsera Generic Name & Formulations

Legal Class

General Description

Adefovir dipivoxil 10mg; tabs.

Pharmacological Class

Nucleotide analogue.

How Supplied

Tabs—30

Manufacturer

Gilead Sciences, Inc.

Hepsera Indications

Indications

Chronic hepatitis B with viral replication and either elevated serum ALT/AST or histologically active disease.

Hepsera Dosage and Administration

Adult

10mg once daily. Renal impairment: CrCl 30–49mL/min: 10mg every 48hrs; CrCl 10–29mL/min: 10mg every 72hrs; CrCl <10mL/min (on hemodialysis): 10mg every 7 days after dialysis; (not on hemodialysis): not recommended.

Children

Not recommended.

Hepsera Contraindications

Not Applicable

Hepsera Boxed Warnings

Boxed Warning

Severe acute exacerbations of hepatitis. Nephrotoxicity. HIV resistance. Lactic acidosis and severe hepatomegaly with steatosis.

Hepsera Warnings/Precautions

Warnings/Precautions

Severe acute exacerbation of hepatitis after discontinuing anti-hepatitis B therapy. Monitor hepatic function during and for several months after treatment. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (eg, lactic acidosis, steatosis). Discontinue if lactic acidosis or hepatotoxicity (hepatomegaly and steatosis) occurs. Unrecognized or untreated HIV co-infection (test for HIV before and during treatment). Obtain baseline renal function, monitor during therapy. Renal impairment. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Hepsera Pharmacokinetics

See Literature

Hepsera Interactions

Interactions

Avoid concomitant Viread or other tenofovir disoproxil fumarate-containing products (eg, Atripla, Truvada, Complera, Stribild). May potentiate or be potentiated by drugs that reduce renal function or compete for renal tubular secretion (monitor). Caution with other nephrotoxic drugs (eg, cyclosporine, tacrolimus, aminoglycosides, vancomycin, NSAIDs).

Hepsera Adverse Reactions

Adverse Reactions

Asthenia, headache, abdominal pain, GI upset, pruritus, lactic acidosis, severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, elevated creatinine, hypophosphatemia; nephrotoxicity (prolonged use).

Hepsera

PAGE CONTENTS