Entecavir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis B

Nucleoside treatment-naive: 0.5 mg orally once a day

Lamivudine-refractory, known lamivudine or telbivudine resistance mutations, or decompensated liver disease: 1 mg orally once a day

Usual Pediatric Dose for Chronic Hepatitis B

16 years or older:
Nucleoside treatment-naive: 0.5 mg orally once a day
Lamivudine-refractory or known lamivudine or telbivudine resistance mutations: 1 mg orally once a day

Renal Dose Adjustments

Nucleoside treatment-naive:
CrCl 30 to less than 50 mL/min: 0.25 mg orally once a day or 0.5 mg orally every 48 hours
CrCl 10 to less than 30 mL/min: 0.15 mg orally once a day or 0.5 mg orally every 72 hours
CrCl less than 10 mL/min: 0.05 mg orally once a day or 0.5 mg orally every 7 days

Lamivudine-refractory, known lamivudine or telbivudine resistance mutations, or decompensated liver disease:
CrCl 30 to less than 50 mL/min: 0.5 mg orally once a day or 1 mg orally every 48 hours
CrCl 10 to less than 30 mL/min: 0.3 mg orally once a day or 1 mg orally every 72 hours
CrCl less than 10 mL/min: 0.1 mg orally once a day or 1 mg orally every 7 days

The once-daily dosing regimen is preferred.

Liver Dose Adjustments

No adjustment recommended.

Precautions

Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients who have discontinued antihepatitis B therapy, including therapy with entecavir. Patients who discontinue entecavir should have close monitoring of hepatic function with clinical and laboratory follow-up for at least several months. If appropriate, resumption of antihepatitis B therapy may be necessary.

Entecavir treatment has not been evaluated in and is not recommended for patients coinfected with HIV and HBV without the additional administration of highly active antiretroviral therapy (HAART). There may be a greater risk of developing resistance to HIV nucleoside reverse transcriptase inhibitors if entecavir therapy is used for chronic HBV in HIV-infected patients who are not receiving adequate treatment for their HIV. HIV antibody testing should be offered to patients prior to starting entecavir therapy. Entecavir has not been studied as a therapy for HIV infection and this use is not recommended.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Risk factors for lactic acidosis may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with entecavir should be stopped in any patient who develops clinical or laboratory signs suggestive of lactic acidosis or hepatotoxicity.

Concurrent administration with drugs that compete for active tubular secretion or reduce renal function may increase serum levels of entecavir and/or the other drugs. Close clinical and laboratory monitoring for adverse effects is recommended and appropriate dosage adjustments should be made if indicated.

The risk of toxicity may be greater in patients with renal impairment. Monitoring of kidney function may be advisable in elderly patients, who are more likely to have reduced renal function.

Limited data are available on the safety and efficacy of entecavir in liver transplant patients. Renal function should be closely monitored before and during treatment in transplant recipients who have received or are receiving immunosuppressants that can affect renal function.

Safety and effectiveness have not been established in the US Hispanic population.

Safety and efficacy have not been established in patients less than 16 years of age.

Dialysis

Hemodialysis or CAPD (once-daily dosing regimen is preferred):
Nucleoside treatment-naive: 0.05 mg orally once a day or 0.5 mg orally every 7 days

Lamivudine-refractory, known lamivudine or telbivudine resistance mutations, or decompensated liver disease: 0.1 mg orally once a day or 1 mg orally every 7 days

Entecavir should be dosed after hemodialysis sessions if administered on dialysis days.

Other Comments

Entecavir should be taken at least 2 hours after a meal and 2 hours before the next meal.

The optimal duration of therapy has not been established. The relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma is unknown.

The tablets and oral solution are bioequivalent and may be used interchangeably without dose adjustment. The oral solution should not be diluted or mixed with other liquids.

Patients using the oral solution should be advised to hold the dosing spoon vertically and slowly fill it to the mark corresponding to the prescribed dose. Rinsing the dosing spoon with water is recommended after each dose.

The oral solution is recommended for doses less than 0.5 mg.

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