entecavir (Rx)

Brand and Other Names:Baraclude
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and entecavir

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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.

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                Adverse Effects

                1-10%

                Fatigue (1-3%)

                Headache (2-4%)

                Dizziness

                Nausea

                <1%

                Diarrhea

                Dyspepsia

                Vomiting

                Somnolence

                Insomnia

                Postmarketing Reports

                Lactic acidosis

                Increased transaminases

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                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

                Do not use Epivir HBV tablets or solution to treat HIV

                Contraindications

                Hypersensitivity

                Cautions

                Discontinuation may result in acute exacerbation of hepatitis B

                Caution in liver transplant recipients or renal impairment

                Pregnancy

                Risk of HIV resistance: not recommended for HIV/HBV coinfected patients who are not also receiving HAART

                Patients with decompensated liver disease may be at greater risk for lactic acidosis

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                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.

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                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

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                entecavir oral
                -
                1 mg tablet
                entecavir oral
                -
                0.5 mg tablet
                entecavir oral
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                0.5 mg tablet
                entecavir oral
                -
                1 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
                -
                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
                entecavir oral
                -
                1 mg tablet
                entecavir oral
                -
                1 mg tablet
                entecavir oral
                -
                0.5 mg tablet
                Baraclude oral
                -
                1 mg tablet
                Baraclude oral
                -
                0.05 mg/mL solution
                Baraclude oral
                -
                0.5 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                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) 2021 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.

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                Formulary

                FormularyPatient Discounts

                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.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.