Chronic hepatitis B virus (HBV) infection with evidence of active viral replication and either persistent elevations in AST or ALT or histologically active disease.
Contraind./Precautions⬆⬇
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.
Concurrent use of drugs that may impair renal function may ↑ levels and risk of toxicity.
Availability⬆⬇
(Generic available)
Oral solution orange flavor: 0.05 mg/mL
Tablets: 0.5 mg; 1 mg
Route/Dosage⬆⬇
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).
US Brand Names⬆⬇
Baraclude
Action⬆⬇
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.
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.
