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 infection in adul

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 pediatric patients

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-administration of entecavir

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 to adequately asses

What precautions should be taken with Entecavir?

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

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

Used to treat:

Infections B34

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