Entecavir dosage and administration
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Dosage And Administration
BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
Recommended Dosage
Compensated Liver Disease
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.
The recommended dose of BARACLUDE in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance mutations rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
Decompensated Liver Disease
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.
Oral Solution
BARACLUDE (entecavir) Oral Solution contains 0.05 mg of entecavir per milliliter. Therefore, 10 mL of the oral solution provides a 0.5 mg dose and 20 mL provides a 1 mg dose of entecavir.
Renal Impairment
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 1. The once-daily dosing regimens are preferred.
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Hepatic Impairment
No dosage adjustment is necessary for patients with hepatic impairment.
Duration of Therapy
The optimal duration of treatment with BARACLUDE for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.