Chronic hepatitis B with viral replication and either elevated serum ALT/AST or histologically active disease.
Adult Dose for HEPSERA:
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.
Discontinue if lactic acidosis or hepatotoxicity occurs. Monitor hepatic function during and for several months after treatment. Women, obesity, or prolonged nucleoside exposure: increased risk of toxicity (eg, lactic acidosis, steatosis). 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.
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).
Asthenia, headache, abdominal pain, GI upset, pruritus, lactic acidosis, severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis, elevated creatinine, hypophosphatemia; nephrotoxicity (prolonged use).
Register pregnant patients exposed to adefovir by calling (800) 258-4263.