entecavir

Therapeutic Classification: antivirals

Pharmacologic Classification: nucleoside analogues

REMS

Chronic hepatitis B virus (HBV) infection with evidence of active viral replication and either persistent elevations in AST or ALT or histologically active disease.

Phosphorylated intracellularly to active form, which acts as an analogue of guanosine, interfering with viral DNA synthesis.

Therapeutic effects:

Decreased hepatic damage due to chronic HBV infection.

Absorption: Well absorbed following oral administration.

Distribution: Extensive tissue distribution.

Metabolism/Excretion: 62–73% excreted unchanged by kidneys.

Half-Life: Plasma: 128–149 hr; intracellular: 15 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	0.5–1 hr	24 hr

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Renal impairment (dose ↓ recommended if CCr <50 mL/min;
Liver transplant recipients (careful monitoring of renal function recommended);
Patients coinfected with HIV (unless receiving highly active antiretroviral therapy; at ↑ risk for resistance);
OB: Other agents preferred for treatment of HBV during pregnancy;
Lactation: Use during breastfeeding only if benefit to patient outweighs potential risk to infant;
Pedi: Children 2 yr (safety and effectiveness not established);
Geri: risk of toxicity in older adults due to age-related in renal function.

Derm: alopecia, rash

F and E: LACTIC ACIDOSIS

GI: hepatomegaly (with steatosis), dyspepsia, nausea

Neuro: dizziness, fatigue, headache

Drug-drug:

Concurrent use of drugs that may impair renal function may ↑ levels and risk of toxicity.

PO (Adults ): Compensated liver disease: 0.5 mg once daily; Decompensated liver disease or history of lamivudine resistance: 1 mg once daily.
PO (Children ≥2 yr and >30 kg): 0.5 mg once daily (1 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >26–30 kg): 0.45 mg once daily (0.9 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >23–26 kg): 0.4 mg once daily (0.8 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >20–23 kg): 0.35 mg once daily (0.7 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >17–20 kg): 0.3 mg once daily (0.6 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >14–17 kg): 0.25 mg once daily (0.5 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and >11–14 kg): 0.2 mg once daily (0.4 mg once daily if history of lamivudine resistance).
PO (Children ≥2 yr and 10–11 kg): 0.15 mg once daily (0.3 mg once daily if history of lamivudine resistance).

Renal Impairment

PO (Adults ): CCr 30–<50 mL/min: 0.25 mg once daily or 0.5 mg every 48 hr (0.5 mg once daily or 1 mg every 48 hr if lamivudine-resistant or decompensated liver disease). CCr 10–<30 mL/min: 0.15 mg once daily or 0.5 mg every 72 hr (0.3 mg once daily or 1 mg every 72 hr if lamivudine-resistant or decompensated liver disease). CCr <10 mL/min, hemodialysis, or CAPD: 0.05 mg once daily or 0.5 mg every 7 days (0.1 mg once daily or 1 mg every 7 days if lamivudine-resistant or decompensated liver disease).

(Generic available)

Oral solution orange flavor: 0.05 mg/mL
Tablets: 0.5 mg; 1 mg

Monitor signs of HBV (jaundice, fatigue, anorexia, pruritus) during and for several mo following discontinuation of therapy. Exacerbations may occur when therapy is discontinued.
May cause lactic acidosis and severe hepatomegaly with steatosis. Monitor patient for signs (↑ serum lactate levels, elevated liver enzymes, liver enlargement on palpation). Suspend therapy if clinical or laboratory signs occur.

Lab Test Considerations:

Monitor liver function closely during and for several mo following discontinuation of therapy. May cause ↑ serum AST, ALT, bilirubin, amylase, lipase, creatinine, and glucose. May cause ↓ serum albumin.

PO: Administer on an empty stomach at least 2 hr before or after a meal. Use oral solution for dose <0.5 mg and children up to 30 kg. Children >30 kg can use oral solution or tablet. Oral solution is ready to use; do not dilute or mix with water or any other liquid. Hold spoon in a vertical position and fill gradually to mark corresponding to prescribed dose. Rinse dosing spoon with water after each daily dose. Store in outer carton at room temperature. After opening, solution can be used until expiration date on bottle.

Instruct patient to take entecavir as directed. Advise patient to read the Patient Information with each refill and to take entecavir as directed. Take missed doses as soon as possible unless almost time for next dose. Do not run out of entecavir; get more when supply runs low. Do not double doses. Emphasize the importance of compliance with full course of therapy, not taking more than the prescribed amount, and not discontinuing without consulting health care professional. Inform patient that hepatitis exacerbation may occur upon discontinuation of therapy. Caution patient not to share medication with others.
Inform patient that entecavir does not cure HBV disease, but may lower the amount of HBV in the body, lower the ability of HBV to multiply and infect new liver cells, and may improve the condition of the liver. Entecavir does not reduce the risk of transmission of HBV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and avoid sharing needles or donating blood to prevent spreading HBV to others.
Advise patient to notify health care professional promptly if signs of lactic acidosis (weakness or tiredness; unusual muscle pain; trouble breathing; stomach pain with nausea and vomiting; feeling cold, especially in arms or legs; dizziness; fast or irregular heartbeat) or hepatotoxicity (jaundice, dark urine, light-colored bowel movements, anorexia, nausea, lower stomach pain) occur.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Discuss the possibility of hair loss with patient. Explore methods of coping.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. Advise female patient to avoid breastfeeding during therapy.
Emphasize the importance of regular follow-up exams and blood tests to determine progress and monitor for side effects.

Decreased hepatic damage due to chronic HBV infection.

NDC Code

0003- E.R. Squibb and Sons, L.L.C.
- 0003-1611- BARACLUDE
  - 0003-1611-12- 1 BOTTLE in 1 CARTON (0003-1611-12) > 30 TABLET, FILM COATED in 1 BOTTLE

0003- E.R. Squibb and Sons, L.L.C.
- 0003-1612- BARACLUDE
  - 0003-1612-12- 1 BOTTLE in 1 CARTON (0003-1612-12) > 30 TABLET, FILM COATED in 1 BOTTLE

0003- E.R. Squibb and Sons, L.L.C.
- 0003-1614- BARACLUDE
  - 0003-1614-12- 1 BOTTLE in 1 CARTON (0003-1614-12) > 210 mL in 1 BOTTLE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-5786- Entecavir
  - 0093-5786-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-5786-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-5786- Entecavir
  - 0093-5786-98- 90 TABLET, FILM COATED in 1 BOTTLE (0093-5786-98)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-5787- Entecavir
  - 0093-5787-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-5787-56)

16714- NorthStar RxLLC
- 16714-717- ENTECAVIR
  - 16714-717-01- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)

16714- NorthStar RxLLC
- 16714-718- ENTECAVIR
  - 16714-718-01- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-718-01)

16729- Accord Healthcare Inc.
- 16729-388- Entecavir
  - 16729-388-10- 30 TABLET, FILM COATED in 1 BOTTLE (16729-388-10)

16729- Accord Healthcare Inc.
- 16729-389- Entecavir
  - 16729-389-10- 30 TABLET, FILM COATED in 1 BOTTLE (16729-389-10)

31722- Camber Pharmaceuticals, Inc.
- 31722-833- Entecavir
  - 31722-833-30- 30 TABLET in 1 BOTTLE (31722-833-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-833- Entecavir
  - 31722-833-31- 10 TABLET in 1 BLISTER PACK (31722-833-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-833- Entecavir
  - 31722-833-32- 100 TABLET in 1 CARTON (31722-833-32)

31722- Camber Pharmaceuticals, Inc.
- 31722-833- Entecavir
  - 31722-833-90- 90 TABLET in 1 BOTTLE (31722-833-90)

31722- Camber Pharmaceuticals, Inc.
- 31722-834- Entecavir
  - 31722-834-30- 30 TABLET in 1 BOTTLE (31722-834-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-834- Entecavir
  - 31722-834-31- 10 TABLET in 1 BLISTER PACK (31722-834-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-834- Entecavir
  - 31722-834-32- 100 TABLET in 1 CARTON (31722-834-32)

31722- Camber Pharmaceuticals, Inc.
- 31722-834- Entecavir
  - 31722-834-90- 90 TABLET in 1 BOTTLE (31722-834-90)

42291- AvKARE, Inc.
- 42291-261- Entecavir
  - 42291-261-30- 30 TABLET, FILM COATED in 1 BOTTLE (42291-261-30)

43547- Solco Healthcare LLC
- 43547-436- ENTECAVIR
  - 43547-436-03- 30 TABLET, FILM COATED in 1 BOTTLE (43547-436-03)

43547- Solco Healthcare LLC
- 43547-436- ENTECAVIR
  - 43547-436-09- 90 TABLET, FILM COATED in 1 BOTTLE (43547-436-09)

43547- Solco Healthcare LLC
- 43547-436- ENTECAVIR
  - 43547-436-15- 500 TABLET, FILM COATED in 1 BOTTLE (43547-436-15)

43547- Solco Healthcare LLC
- 43547-437- ENTECAVIR
  - 43547-437-03- 30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03)

43547- Solco Healthcare LLC
- 43547-437- ENTECAVIR
  - 43547-437-09- 90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09)

43547- Solco Healthcare LLC
- 43547-437- ENTECAVIR
  - 43547-437-15- 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-15)

49884- Par Pharmaceutical, Inc.
- 49884-547- Entecavir
  - 49884-547-09- 90 TABLET, COATED in 1 BOTTLE (49884-547-09)

49884- Par Pharmaceutical, Inc.
- 49884-547- Entecavir
  - 49884-547-11- 30 TABLET, COATED in 1 BOTTLE (49884-547-11)

49884- Par Pharmaceutical, Inc.
- 49884-548- Entecavir
  - 49884-548-09- 90 TABLET, COATED in 1 BOTTLE (49884-548-09)

49884- Par Pharmaceutical, Inc.
- 49884-548- Entecavir
  - 49884-548-11- 30 TABLET, COATED in 1 BOTTLE (49884-548-11)

51407- Golden State Medical Supply Inc.
- 51407-064- Entecavir
  - 51407-064-30- 30 TABLET, FILM COATED in 1 BOTTLE (51407-064-30)

51407- Golden State Medical Supply Inc.
- 51407-065- Entecavir
  - 51407-065-30- 30 TABLET, FILM COATED in 1 BOTTLE (51407-065-30)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-895- Entecavir
  - 51991-895-33- 30 TABLET in 1 BOTTLE, PLASTIC (51991-895-33)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-895- Entecavir
  - 51991-895-90- 90 TABLET in 1 BOTTLE, PLASTIC (51991-895-90)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-896- Entecavir
  - 51991-896-33- 30 TABLET in 1 BOTTLE, PLASTIC (51991-896-33)

52343- ACETRIS HEALTH, LLC
- 52343-147- ENTECAVIR
  - 52343-147-30- 30 CARTON in 1 BOTTLE (52343-147-30) > 1 TABLET in 1 CARTON

52343- ACETRIS HEALTH, LLC
- 52343-148- ENTECAVIR
  - 52343-148-30- 30 CARTON in 1 BOTTLE (52343-148-30) > 1 TABLET in 1 CARTON

60687- American Health Packaging
- 60687-216- Entecavir
  - 60687-216-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) > 1 TABLET in 1 BLISTER PACK (60687-216-95)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-101- Entecavir
  - 62227-101-01- 30 TABLET in 1 BOTTLE, PLASTIC (62227-101-01)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-101- Entecavir
  - 62227-101-02- 90 TABLET in 1 BOTTLE, PLASTIC (62227-101-02)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-101- Entecavir
  - 62227-101-03- 3000 TABLET in 1 BOTTLE, PLASTIC (62227-101-03)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-102- Entecavir
  - 62227-102-01- 30 TABLET in 1 BOTTLE, PLASTIC (62227-102-01)

62227- BrightGene Bio-Medical Technology Co., Ltd.
- 62227-102- Entecavir
  - 62227-102-02- 1500 TABLET in 1 BOTTLE, PLASTIC (62227-102-02)

65162- Amneal Pharmaceuticals LLC
- 65162-446- Entecavir
  - 65162-446-03- 30 TABLET, FILM COATED in 1 BOTTLE (65162-446-03)

65162- Amneal Pharmaceuticals LLC
- 65162-449- Entecavir
  - 65162-449-03- 30 TABLET, FILM COATED in 1 BOTTLE (65162-449-03)

65862- Aurobindo Pharma Limited
- 65862-841- Entecavir
  - 65862-841-30- 1 BOTTLE in 1 CARTON (65862-841-30) > 30 TABLET in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-841- Entecavir
  - 65862-841-90- 1 BOTTLE in 1 CARTON (65862-841-90) > 90 TABLET in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-841- Entecavir
  - 65862-841-99- 1 BOTTLE in 1 CARTON (65862-841-99) > 1000 TABLET in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-842- Entecavir
  - 65862-842-30- 1 BOTTLE in 1 CARTON (65862-842-30) > 30 TABLET in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-842- Entecavir
  - 65862-842-90- 1 BOTTLE in 1 CARTON (65862-842-90) > 90 TABLET in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-842- Entecavir
  - 65862-842-99- 1 BOTTLE in 1 CARTON (65862-842-99) > 1000 TABLET in 1 BOTTLE

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-920- Entecavir
  - 68382-920-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-920-01)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-920- Entecavir
  - 68382-920-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-920-06)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-920- Entecavir
  - 68382-920-16- 90 TABLET, FILM COATED in 1 BOTTLE (68382-920-16)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-920- Entecavir
  - 68382-920-77- 10 BLISTER PACK in 1 CARTON (68382-920-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-920-30)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-921- Entecavir
  - 68382-921-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-921- Entecavir
  - 68382-921-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-921- Entecavir
  - 68382-921-16- 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-921- Entecavir
  - 68382-921-77- 10 BLISTER PACK in 1 CARTON (68382-921-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)

69097- Cipla USA Inc.
- 69097-425- ENTECAVIR
  - 69097-425-02- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-425-02)

69097- Cipla USA Inc.
- 69097-426- ENTECAVIR
  - 69097-426-02- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-02)

69097- Cipla USA Inc.
- 69097-426- ENTECAVIR
  - 69097-426-05- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-05)

70771- Cadila Healthcare Limited
- 70771-1019- Entecavir
  - 70771-1019-1- 100 TABLET, FILM COATED in 1 BOTTLE (70771-1019-1)

70771- Cadila Healthcare Limited
- 70771-1019- Entecavir
  - 70771-1019-3- 30 TABLET, FILM COATED in 1 BOTTLE (70771-1019-3)

70771- Cadila Healthcare Limited
- 70771-1019- Entecavir
  - 70771-1019-4- 10 BLISTER PACK in 1 CARTON (70771-1019-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1019-2)

70771- Cadila Healthcare Limited
- 70771-1019- Entecavir
  - 70771-1019-9- 90 TABLET, FILM COATED in 1 BOTTLE (70771-1019-9)

70771- Cadila Healthcare Limited
- 70771-1020- Entecavir
  - 70771-1020-1- 100 TABLET, FILM COATED in 1 BOTTLE (70771-1020-1)

70771- Cadila Healthcare Limited
- 70771-1020- Entecavir
  - 70771-1020-3- 30 TABLET, FILM COATED in 1 BOTTLE (70771-1020-3)

70771- Cadila Healthcare Limited
- 70771-1020- Entecavir
  - 70771-1020-4- 10 BLISTER PACK in 1 CARTON (70771-1020-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1020-2)

70771- Cadila Healthcare Limited
- 70771-1020- Entecavir
  - 70771-1020-9- 90 TABLET, FILM COATED in 1 BOTTLE (70771-1020-9)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆