Dosing & Uses
Dosage Forms & Strengths
tablet
- 0.5mg
- 1mg
oral solution
- 0.05mg/mL
Chronic Hepatitis B
Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Nucleoside inhibitor treatment-naïve with compensated liver disease (adults and adolescents ≥16 yr): 0.5 mg PO qDay
Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (adults and adolescents ≥16 yr): 1 mg PO qDay
Decompensated liver disease (adults): 1 mg PO qDay
Indication is based on the following
- Histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistance with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease
- Virologic, biochemical, serologic, and safety data are available from a controlled study with chronic HBV infection and decompensated liver disease
- Virologic, biochemical, serologic, and safety data are available for a limited number of adults with HIV/HBV coinfection who have received prior lamivudine therapy
Renal Impairment
Usual daily dose (0.5 mg)
- CrCl ≥50 mL/min: No dosage adjustment required
- CrCl 30-49 mL/min: Reduce to 0.25 mg/day or 0.5 mg q48hr
- CrCl 10-29 mL/min: Reduce to 0.15 mg/day or 0.5 mg q72hr
- CrCl <10 mL/min, hemodialysis, or CAPD: 0.05 mg/day or 0.5 mg q7days
Lamivudine-refractory/decompensated liver disease daily dose (1 mg)
- CrCl ≥50 mL/min: No dosage adjustment required
- CrCl 30-49 mL/min: Reduce to 0.5 mg/day or 1 mg q48hr
- CrCl 10-29 mL/min: Reduce to 0.3 mg/day or 1 mg q72hr
- CrCl <10 mL/min, hemodialysis, or CAPD: 0.1 mg/day or 1 mg q7days
Administration
Take on empty stomach (2 hr AC or PC)
Use oral solution when needed for renal impairment dosage adjustments
Dosage Forms & Strengths
tablet
- 0.5mg
- 1mg
oral solution
- 0.05mg/mL
Chronic Hepatitis B
Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease in children ≥2 years and weigh at least 10 kg
<2 years: Safety and efficacy not established
≥16 years: As adult
Nucleoside inhibitor treatment-naïve
- Administer PO once daily
- 10-11 kg: 0.15 mg (3 mL)
- >11-14 kg: 0.2 mg (4 mL)
- >14-17 kg: 0.25 mg (5 mL)
- >17-20 kg: 0.3 mg (6 mL)
- >20-23 kg: 0.35 mg (7 mL)
- >23-26 kg: 0.4 mg (8 mL)
- >26-30 kg: 0.45 mg (9 mL)
- >30 kg: 0.5 mg (10 mL oral solution or one 0.5-mg tab)
Lamivudine-experienced
- Administer PO once daily
- 10-11 kg: 0.3 mg (6 mL)
- >11-14 kg: 0.4 mg (8 mL)
- >14-17 kg: 0.5 mg (10 mL)
- >17-20 kg: 0.6 mg (12 mL)
- >20-23 kg: 0.7 mg (14 mL)
- >23-26 kg: 0.8 mg (16 mL)
- >26-30 kg: 0.9 mg (18 mL)
- >30 kg: 1 mg (20 mL oral solution or one 1-mg tab)
Renal Impairment
Insufficient data exist to recommend a specific dose adjustment in pediatric patients with renal impairment
Consider dose reductions or dosing interval increases similar to adult adjustments
Administration
Take on empty stomach (2 hr AC or PC)
Use oral solution for children weighing 10-30 kg
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (3)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
entecavir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Either increases toxicity of the other by decreasing renal clearance. Use Caution/Monitor. Toxicity may result from coadministration of emtricitabine and tenofovir with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion .
entecavir and elvitegravir/cobicistat/emtricitabine/tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. - metformin
entecavir, metformin. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Coadministration of entecavir with metformin may increase the risk of lactic acidosis.
- tenofovir DF
tenofovir DF increases levels of entecavir by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. Both drugs are excreted by active tubular secretion.
Minor (60)
- alendronate
alendronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- amikacin
amikacin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- amikacin liposome inhalation
amikacin liposome inhalation, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- amiloride
amiloride, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- azilsartan
azilsartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- benazepril
benazepril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- candesartan
candesartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- captopril
captopril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- cidofovir
cidofovir, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- creatine
creatine, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- crizotinib
crizotinib, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- cyclosporine
cyclosporine, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- diflunisal
diflunisal, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- enalapril
enalapril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- eprosartan
eprosartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- ethacrynic acid
ethacrynic acid, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- etidronate
etidronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- foscarnet
foscarnet, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- fosinopril
fosinopril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- gallium nitrate
gallium nitrate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- ganciclovir
ganciclovir, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- gentamicin
gentamicin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- ibandronate
ibandronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- irbesartan
irbesartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- kanamycin
kanamycin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- letermovir
letermovir, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- lisinopril
lisinopril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- losartan
losartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- mannitol
mannitol, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- mefenamic acid
mefenamic acid, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- mesalamine
mesalamine, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- moexipril
moexipril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- neomycin PO
neomycin PO, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- olmesartan
olmesartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- oxaliplatin
oxaliplatin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- pamidronate
pamidronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- pemetrexed
pemetrexed, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- pentamidine
pentamidine, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- perindopril
perindopril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- pindolol
pindolol, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- plazomicin
plazomicin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- polymyxin B
polymyxin B, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- procainamide
procainamide, entecavir. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- quinapril
quinapril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- ramipril
ramipril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- risedronate
risedronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- sacubitril/valsartan
sacubitril/valsartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- streptomycin
streptomycin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- sulindac
sulindac, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- tacrolimus
tacrolimus, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- telavancin
telavancin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- telmisartan
telmisartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- tobramycin
tobramycin, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- tobramycin inhaled
tobramycin inhaled, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- trandolapril
trandolapril, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- triamterene
triamterene, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- valganciclovir
valganciclovir, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- valsartan
valsartan, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- zoledronic acid
zoledronic acid, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- zonisamide
zonisamide, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
Adverse Effects
1-10%
Fatigue (1-3%)
Headache (2-4%)
Dizziness
Nausea
<1%
Diarrhea
Dyspepsia
Vomiting
Somnolence
Insomnia
Postmarketing Reports
Lactic acidosis
Increased transaminases
Warnings
Black Box Warnings
Severe acute exacerbations of hepatitis reported following discontinuing drug; monitor hepatic function
Resistance to HIV NRTIs may emerge in patients with chronic hepatitis B in whom HIV infection is unrecognized or untreated
Not for HIV/HBV coinfected patients unless being treated with highly active antiretroviral therapy (HAART)
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported
Contraindications
Hypersensitivity
Cautions
Use caution in liver transplant recipients or renal impairment
Discontinuation of anti-hepatitis therapy may result in severe acute exacerbations of hepatitis B; closely monitor hepatic function with both clinical and laboratory follow-up for at least several months after discontinuing therapy; if appropriate, initiation of anti-hepatitis B therapy may be warranted
Lactic acidosis and severe hepatomegaly with steatosis
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analog inhibitors, including this drug administered alone or in combination with antiretrovirals
- A majority of cases have been in women; obesity and prolonged nucleoside inhibitor exposure may be risk factors; particular caution should be exercised when administering nucleoside analogue inhibitors to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors
- Lactic acidosis reported with therapy, often in association with hepatic decompensation, other serious medical conditions, or drug exposures; patients with decompensated liver disease may be at higher risk for lactic acidosis
- Treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)
Patients coinfected with HIV and HBV
- This drug has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment; limited clinical experience suggests there is a potential for development of resistance to HIV nucleoside reverse transcriptase inhibitors if the drug is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated
- Therefore, therapy is not recommended for HIV/HBV co-infected patients not also receiving HAART; before initiating therapy, HIV antibody testing should be offered to all patients; this drug has not been studied as a treatment for HIV infection and is not recommended for this use
Pregnancy & Lactation
Pregnancy
Pregnancy registry: Healthcare providers are encouraged to register pregnant women exposed to entecavir by calling 1-800-258-4263
Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes; use during pregnancy has been evaluated in a limited number of individuals reported to APR and number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population; rate of miscarriage is not reported in APR; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes
Animal data
- In animal reproduction studies, no adverse developmental effects were observed with entecavir at clinically relevant exposures; no developmental toxicities were observed at systemic exposures (AUC) approximately 25 (rats) and 200 (rabbits) times exposure at maximum recommended human dose (MRHD) of 1 mg/day
Lactation
Not known whether drug is present in human breast milk, affects human milk production, or has effects on the breastfed infant; when administered to lactating rats, entecavir was present in milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective HBV DNA polymerase inhibitor; inhibition blocks reverse transcriptase activity, which in turn reduces viral DNA synthesis
Pharmacokinetics
Half-Life, elimination: 5-6 days
Peak plasma time: 0.5-1.5 hr
Peak plasma concentration: 0.5 mg dose: 4.2 ng/mL; 1 mg dose: 8.2 ng/mL
Distribution: Extensively in tissues
Protein bound: 13%
Metabolism: Not a substrate, inducer or inhibitor of the Cytochrome P450 system
Excretion: Primarily urine
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Baraclude oral - | 0.05 mg/mL solution |  | |
| Baraclude oral - | 1 mg tablet |  | |
| Baraclude oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 0.5 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  | |
| entecavir oral - | 1 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
entecavir oral
ENTECAVIR - ORAL
(en-TEK-a-vir)
COMMON BRAND NAME(S): Baraclude
WARNING: Rarely, entecavir may cause serious (possibly fatal) liver problems and lactic acid build-up in the blood (lactic acidosis). Get medical help right away if you have any of the following symptoms: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness/weakness, deep/fast breathing, unusual drowsiness, unusual muscle pain, feeling cold in your arms/legs, fast/irregular heartbeat. These side effects may occur more often in women and obese patients.Your hepatitis B infection may get worse if you stop taking entecavir. Do not stop this medication without talking to your doctor. Your doctor will do blood tests to check your liver for several months after you stop entecavir.This medication is not recommended if you have both HIV and hepatitis B and are not receiving effective treatment for HIV. This drug does not treat HIV, and it can cause certain HIV medications to become ineffective. Get an HIV test before starting this medication, and get tested again anytime you may have become infected. Consult your doctor for more details.
USES: See also Warning section.Entecavir is used to treat long-term hepatitis B infection. Hepatitis B is an infection of the liver caused by the hepatitis B virus. Long-term infection can cause liver damage, rarely liver cancer, and liver failure. Entecavir helps to decrease the amount of hepatitis B virus in your body. It is unknown if this medication lowers your chance of getting liver cancer or liver damage. Entecavir is an antiviral that belongs to a class of drugs known as hepatitis B virus nucleoside reverse transcriptase inhibitors.Entecavir is not a cure for hepatitis B. It does not prevent the spread of the virus to others through sexual contact or blood/body fluid contamination (such as sharing used needles).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking entecavir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal) as directed by your doctor, usually once daily.If you are taking entecavir oral liquid, carefully measure your dose with the medicine spoon provided. Do not use a household spoon because you may not get the correct dose. Swallow the medicine directly from the measuring spoon. Do not mix the medication with water or other liquids. Rinse the spoon with water after each use.The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses.This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. See also Warning section.Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: See also Warning section.Headache, tiredness, dizziness, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking entecavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney disease, other hepatitis B drugs taken in the past.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Alcohol may also worsen liver problems. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To decrease your risk of spreading hepatitis B to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.During pregnancy, this medication should be used only when clearly needed. It is not known if this medication helps to prevent the hepatitis B virus from passing from the mother to the baby. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. If you also have HIV infection, do not breast-feed because breast milk can transmit HIV.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver tests, virus levels) should be done while you are taking this medication. Keep all medical and lab appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. To protect from light, store the bottle of medication in the original carton. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
