Drug reference

Entecavir

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 680

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

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

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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.

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Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

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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

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Safety

Side Effects

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

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Conception And Contraception

Effective contraception required during treatment.

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Pregnancy

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

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Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

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Renal Impairment

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

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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).

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Dose and formulations

Directions For Administration

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

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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

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Clinical care

Patient And Carer Advice

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

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Dose text by age group

Adult

500 micrograms once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Adult

1 mg once daily, consider other treatment if

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Adult

1 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Entecavir

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 680

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 680

Cautions

PDF page 680

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

PDF page 680

National Funding Access Decisions

PDF page 680

Safety

Side Effects

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

PDF page 680

Conception And Contraception

Effective contraception required during treatment.

PDF page 680

Pregnancy

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

PDF page 680

Breast Feeding

Manufacturer advises avoid—present in milk in animal studies.

PDF page 680

Renal Impairment

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

PDF page 680

Monitoring Requirements

PDF page 680

Dose and formulations

Directions For Administration

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

PDF page 680

Medicinal Forms

PDF page 680

Clinical care

Patient And Carer Advice

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

PDF page 680

Dose text by age group

Adult

500 micrograms once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Adult

1 mg once daily, consider other treatment if

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Adult

1 mg once daily

First-line fragment. Read the complete Indications and Dose section above.

PDF page 680

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.