Adult Dosing
Chronic HBV
Compensated Liver Disease, nucleoside- naïve
Compensated Liver Disease, history of hepatitis B viremia/resistance with lamivudine
Decompensated Liver Disease
Note:
- Should be administered on an empty stomach at least 2 hrs after meal or 2 hrs before the next meal
Pediatric Dosing
- Safety and efficacy < 2years of age have not be established
Chronic HBV (
2 yrs)
Compensated Liver Disease, nucleoside- naïve
- 10-11 kg: 0.15 mg PO Daily
- >11-14 kg: 0.2 mg PO Daily
- >14-17 kg: 0.25 mg PO Daily
- >17-20 kg: 0.3 mg PO Daily
- >20-23 kg: 0.35 mg PO Daily
- >23-26 kg: 0.4 mg PO Daily
- >26-30 kg: 0.45 mg PO Daily
- >30 kg: 0.5 mg PO Daily
Compensated Liver Disease, history of hepatitis B viremia/resistance with lamivudine (2 yrs)
- 10-11 kg: 0.3 mg PO Daily
- >11-14 kg: 0.4 mg PO Daily
- >14-17 kg: 0.5 mg PO Daily
- >17-20 kg: 0.6 mg PO Daily
- >20-23 kg: 0.7 mg PO Daily
- >23-26 kg: 0.8 mg PO Daily
- >26-30 kg: 0.9 mg PO Daily
- >30 kg: 1 mg PO Daily
Note:
- Should be administered on an empty stomach at least 2 hours after meal or 2 hours before the next meal and use oral solution for children with body weight up to 30 kg
Renal Dose Adjustment (Based on CrCl)
Nucleoside-naive patients
- <50 mL/min: 0.5 mg Daily
- 30-<50 mL/min: 0.25 mg Daily or 0.5 mg q48 hrs
- 10-<30 mL/min: 0.15 mg Daily or 0.5 mg q72 hrs
- <10 mL/min: 0.05 mg Daily or 0.5 mg q7 days
- HD/CAPD: 0.05 mg Daily or 0.5 mg q7 days
Lamivudine refractory patients
- < 50 mL/min: 1 mg Daily
- 30-<50 mL/min: 0.5 mg Daily or 1 mg q48 hrs
- 10-<30 mL/min: 0.3 mg Daily or 1 mg q72 hrs
- <10 mL/min: 0.1 mg Daily or 1 mg q7 days
- HD/CAPD: 0.1 mg Daily or 1 mg q7 days
Note:
- In pediatric patients with renal impairment dosing adjustments not defined; see adult renal dosing for guidance
Hepatic Dose Adjustment
- Hepatic impairment: Dosage adjustments not indicated
- Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy [US Black Box Warning]
- Entecavir s not recommended in HIV/ HBV coinfected patients who are not taking highly active antiretroviral therapy. Before initiating entecavir therapy evaluate for HIV antibody testing [US Black Box Warning]
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases can occur with nucleoside analogues alone or in combination with antiretrovirals [US Black Box Warning]
- Patients with decompensated liver disease are at higher risk for lactic acidosis. discontinue the treatment if there is clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Due to potential to cause hepatotoxicity, measure LFT's at baseline and for several months after discontinuing. Monitor CrCl at baseline
Cautions: Use cautiously in
- Renal impairment, see dosage adjustments
- Risk factors for liver disease
- Liver transplant
- Obesity
- Long term use
Pregnancy Category:C
Breastfeeding: Safety unknown; no studies conducted on entecavir in nursing mother being treated for hepatitis B infection. Of 226 physicians surveyed in US a survey 31% stated that they recommend breastfeeding for their patients with hepatitis B who are taking antiviral therapy, 44% stated that they do not recommend breastfeeding during antiviral therapy and 25% stated that they were unsure based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 28 Jan 2011). As per manufacturer data entecavir is excreted in the milk of rats; because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Baraclude 1 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $920.98
90 mg = $2705.96 - Baraclude 0.5 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $937
90 mg = $2629.11
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Baraclude 0.5 MG Oral Tablet
Ingredient(s): Entecavir
Imprint: BMS;1611
Color(s): White
Shape: Triangle
Size (mm): 8.00
Score: 1
Inactive Ingredient(s): lactose monohydrate / cellulose, microcrystalline / crospovidone / povidone / magnesium stearate / titanium dioxide / hypromellose / polyethylene glycol 400 / polysorbate 80
Drug Label Author:
E.R. Squibb & Sons, L.L.C.
DEA Schedule:
Non-Scheduled
Drug Name: Baraclude 1 MG Oral Tablet
Ingredient(s): Entecavir
Imprint: BMS;1612
Color(s): Pink
Shape: Triangle
Size (mm): 10.00
Score: 1
Inactive Ingredient(s): lactose monohydrate / cellulose, microcrystalline / crospovidone / povidone / magnesium stearate / titanium dioxide / hypromellose / polyethylene glycol 400 / ferric oxide red
Drug Label Author:
E.R. Squibb & Sons, L.L.C.
DEA Schedule:
Non-Scheduled
