Individual generic drug information

entecavir

Reference monograph

Part of registered formulation

ENTECAVIR

Reference record: Entecavir
Source: BNF 80 (2020–2021)
Printed source pages: 680
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Entecavir only.

Indications And Dose

Chronic hepatitis B in patients with compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis) not previously treated with nucleoside analogues ▶BY MOUTH ▶Adult: 500 micrograms once daily Chronic hepatitis B in patients with compensated liver disease (with evidence of viral replication, and histologically documented active liver inflammation or fibrosis) and lamivudine-resistance ▶BY MOUTH ▶Adult: 1 mg once daily, consider other treatment if inadequate response after 6 months Chronic hepatitis B in patients with decompensated liver disease ▶BY MOUTH ▶Adult: 1 mg once daily

Source page 680

Cautions

HIV infection—risk of HIV resistance in patients not receiving ‘highly active antiretroviral therapy’ . lamivudine-resistant chronic hepatitis B—risk of entecavir resistance CAUTIONS, FURTHER INFORMATION Discontinue if deterioration in liver function, hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis.

Source page 680

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

Source page 680

National Funding Access Decisions

NICE decisions ▶Entecavir for the treatment of chronic hepatitis B (August 2008) NICE TA153 Entecavir, within its marketing authorisation, is recommended as an option for the treatment of people with chronic HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral treatment is indicated. This guidance does not apply to people with chronic hepatitis B who also have hepatitis C, hepatitis D or HIV. www.nice.org.uk/guidance/ta153

Source page 680

Safety

Extracted information for Entecavir only.

Side Effects

▶Common or very common Diarrhoea. dizziness. drowsiness . dyspepsia. fatigue. headache. insomnia. nausea. vomiting ▶Uncommon Alopecia. rash ▶Frequency not known Lactic acidosis

Source page 680

Conception And Contraception

Effective contraception required during treatment.

Source page 680

Pregnancy

Toxicity in animal studies—manufacturer advises use only if potential beneﬁt outweighs risk.

Source page 680

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 680

Renal Impairment

Consult product literature. Dose adjustments Reduce dose if eGFR less than 50 mL/minute/1.73 m2.

Source page 680

Monitoring Requirements

Monitor liver function tests every 3 months, and viral markers for hepatitis B every 3–6 months during treatment (continue monitoring for at least 1 year after discontinuation—recurrent hepatitis may occur on discontinuation).

Source page 680

Dose and formulations

Extracted information for Entecavir only.

Directions For Administration

To be taken at least 2 hours before or 2 hours after food.

Source page 680

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oral solution ▶Baraclude (Bristol-Myers Squibb Pharmaceuticals Ltd) Entecavir (as Entecavir monohydrate) 50 microgram per 1 ml Baraclude 0.05mg/ml oral solution sugar-free | 210 ml P £423.80 DT = £423.80 Tablet ▶Entecavir (Non-proprietary) Entecavir (as Entecavir monohydrate) 500 microgram Entecavir 500microgram tablets | 30 tablet P £26.13–£363.26 DT = £363.26 Entecavir (as Entecavir monohydrate) 1 mg Entecavir 1mg tablets | 30 tablet P £363.26 DT = £363.26 ▶Baraclude (Bristol-Myers Squibb Pharmaceuticals Ltd) Entecavir (as Entecavir monohydrate) 500 microgram Baraclude 0.5mg tablets | 30 tablet P £363.26 DT = £363.26 Entecavir (as Entecavir monohydrate) 1 mg Baraclude 1mg tablets | 30 tablet P £363.26 DT = £363.26

Source page 680

Clinical care

Extracted information for Entecavir only.

Patient And Carer Advice

Patients or carers should be counselled on the administration of entecavir tablets and oral solution.

Source page 680

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

500 micrograms once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Adults

First line only; read the complete Indications and dose section above.

1 mg once daily, consider other treatment if

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Adults

First line only; read the complete Indications and dose section above.

1 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

entecavir

Reference monograph

Part of registered formulation

ENTECAVIR

Reference record: Entecavir
Source: BNF 80 (2020–2021)
Printed source pages: 680
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Entecavir only.

Indications And Dose

Source page 680

Cautions

Source page 680

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

Source page 680

National Funding Access Decisions

Source page 680

Safety

Extracted information for Entecavir only.

Side Effects

▶Common or very common Diarrhoea. dizziness. drowsiness . dyspepsia. fatigue. headache. insomnia. nausea. vomiting ▶Uncommon Alopecia. rash ▶Frequency not known Lactic acidosis

Source page 680

Conception And Contraception

Effective contraception required during treatment.

Source page 680

Pregnancy

Toxicity in animal studies—manufacturer advises use only if potential beneﬁt outweighs risk.

Source page 680

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

Source page 680

Renal Impairment

Consult product literature. Dose adjustments Reduce dose if eGFR less than 50 mL/minute/1.73 m2.

Source page 680

Monitoring Requirements

Source page 680

Dose and formulations

Extracted information for Entecavir only.

Directions For Administration

To be taken at least 2 hours before or 2 hours after food.

Source page 680

Medicinal Forms

Source page 680

Clinical care

Extracted information for Entecavir only.

Patient And Carer Advice

Patients or carers should be counselled on the administration of entecavir tablets and oral solution.

Source page 680

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

500 micrograms once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Adults

First line only; read the complete Indications and dose section above.

1 mg once daily, consider other treatment if

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Adults

First line only; read the complete Indications and dose section above.

1 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 680

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.