What is Entecavir used for?

1 INDICATIONS AND USAGE Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus

How does Entecavir work?

11 DESCRIPTION Entecavir, USP is a guanosine nucleoside analogue with selective activity against HBV.

What pharmaceutical form is Entecavir available in?

Entecavir: Tabletki powlekane 0,5 mg (doustna)

Is Entecavir OTC or prescription only?

Entecavir requires a doctor's prescription.

What are the side effects of Entecavir?

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis after discontinuation of treatment [see Boxed Warning , Warnings and Precautions (5.1) ] . Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning , Warnings and Precautions (5.3) ] . In adults, the most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in

Who should NOT take Entecavir?

4 CONTRAINDICATIONS None. None. (4)

Does Entecavir interact with other medications?

7 DRUG INTERACTIONS Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) ] , co-administration of entecavir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the co-administered drug. Co-administration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir disoproxil fumarate did not result in significant drug interactions. The effects of co-administr

Can Entecavir be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Liver transplant recipients: Limited data on safety and efficacy are available. (8.8) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Prospective pregnancy data from the APR are not sufficient t

What precautions should be taken with Entecavir?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures Entecavir?

Bristol-Myers Squibb Pharma EEIG (Irlandia)

What ATC class does Entecavir belong to?

Entecavir: ATC J05AF10. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Entecavir

0,5 mg, Tabletki powlekane

INN: Entecavirum

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

0,5 mg

Route

doustna

Storage

—

About This Product

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