Entecavir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis B

Compensated Liver Disease:
-Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day
-History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day

Decompensated Liver Disease: 1 mg orally once a day

Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

Usual Pediatric Dose for Chronic Hepatitis B

2 to 15 years:
Therapy-naive:
10 to 11 kg: 0.15 mg orally once a day
Greater than 11 to 14 kg: 0.2 mg orally once a day
Greater than 14 to 17 kg: 0.25 mg orally once a day
Greater than 17 to 20 kg: 0.3 mg orally once a day
Greater than 20 to 23 kg: 0.35 mg orally once a day
Greater than 23 to 26 kg: 0.4 mg orally once a day
Greater than 26 to 30 kg: 0.45 mg orally once a day
Greater than 30 kg: 0.5 mg orally once a day

Lamivudine-experienced:
10 to 11 kg: 0.3 mg orally once a day
Greater than 11 to 14 kg: 0.4 mg orally once a day
Greater than 14 to 17 kg: 0.5 mg orally once a day
Greater than 17 to 20 kg: 0.6 mg orally once a day
Greater than 20 to 23 kg: 0.7 mg orally once a day
Greater than 23 to 26 kg: 0.8 mg orally once a day
Greater than 26 to 30 kg: 0.9 mg orally once a day
Greater than 30 kg: 1 mg orally once a day

Comments:
-The oral solution is recommended for patients up to 30 kg.

16 years or older:
Compensated Liver Disease:
-Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day
-History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day

Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

Renal Dose Adjustments

Adult Patients:
Nucleoside-inhibitor-therapy-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 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

Comments:
-The once-daily dosing regimen is preferred.

Pediatric Patients: Data not available

Comments:
-Dose reduction or increased dosing interval similar to adult dose adjustments should be considered.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNINGS:
-SEVERE ACUTE EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients who have discontinued antihepatitis B therapy. Patients who discontinue this drug 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.
-PATIENTS COINFECTED WITH HIV AND HBV: This drug is not recommended for HIV/HBV-coinfected patients not also receiving HAART. There is a risk of developing resistance to HIV nucleoside reverse transcriptase inhibitors if this drug is used for chronic HBV in coinfected patients not receiving adequate treatment for their HIV infection.
-LACTIC ACIDOSIS AND HEPATOMEGALY: Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analog inhibitors, alone or in combination with antiretrovirals.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Adult Patients:
Hemodialysis or CAPD:
-Nucleoside-inhibitor-therapy-naive: 0.05 mg orally once a day or 0.5 mg orally every 7 days
-Lamivudine-refractory or decompensated liver disease: 0.1 mg orally once a day or 1 mg orally every 7 days

Comments:
-The once-daily dosing regimen is preferred.
-This drug should be dosed after hemodialysis sessions if administered on hemodialysis days.

Pediatric Patients: Data not available

Comments:
-Dose reduction or increased dosing interval similar to adult dose adjustments should be considered.

Other Comments

Administration advice:
-Administer at least 2 hours after a meal and 2 hours before the next meal.
-May use the tablets and oral solution interchangeably without dose adjustment; they are bioequivalent.
-Use the oral solution for doses less than 0.5 mg.
-Do not dilute the oral solution or mix it with other liquids.

Storage requirements:
-Oral solution: Store in outer carton; protect from light.
-Tablets: Store in tightly closed container; store in outer carton to protect from light

General:
-Optimal duration of therapy has not been established.
-Relationship between therapy and long-term outcomes (e.g., cirrhosis, hepatocellular carcinoma) is unknown.

Monitoring:
-Hepatic: Hepatic function (periodically during therapy; for at least several months after stopping therapy)
-Infections/Infestations: HIV antibody testing (before starting therapy)
-Renal: Renal function in elderly patients

Patient advice:
-If using the oral solution, hold the dosing spoon vertically and slowly fill it to the mark corresponding to the prescribed dose; rinse the dosing spoon with water after each dose.

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