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Bulevirtide parenteral

Updated 2 Feb 2023 | Bulevirtide

Presentation

Injections of bulevirtide.

Drugs List

  • bulevirtide 2mg powder for solution for injection vial
  • HEPCLUDEX 2mg powder for solution for injection vial
  • Therapeutic Indications

    Uses

    Chronic hepatitis D

    For the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.

    Dosage

    Bulevirtide can be administered as monotherapy or in co-administration with a nucleoside/nucleotide analogue for treatment of underlying HBV infection.

    Adults

    2mg every 24 hours.

    Optimal treatment duration is unknown. Treatment should be continued as long as associated with clinical benefit.

    Additional Dosage Information

    Missed dose
    If an infection has been missed by less than 4 hours, the dose should be administered as soon as possible and the next injection should follow the previously established schedule. If an injection has been missed by more than 4 hours then the missed dose should not be administered. If the injection has been administered more than 4 hours since the scheduled time then the next dose should follow the original schedule.

    Administration

    For subcutaneous injection only. The injection sites for bulevirtide may be the upper thigh, or abdomen.

    Contraindications

    Children under 18 years
    Breastfeeding
    Decompensated liver disease
    Pregnancy

    Precautions and Warnings

    Females of childbearing potential
    Patients over 65 years
    Hepatitis B
    Hepatitis C
    Moderate hepatic impairment
    Positive HIV status
    Renal impairment

    Monitor HBV levels during and after treatment in patients with co-infection
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment should be started by a doctor experienced in hepatitis management
    Contains mannitol
    Monitor renal function
    Discontinuation may reactivate HBV & HDV infection and exacerbate hepatitis
    Female: Ensure adequate contraception during treatment

    Elevation of bile salts may occur during treatment. Due to renal excretion of bile salts, elevation of bile salts may be greater in patients with renal impairment.

    The underlying HBV infection should be simultaneously managed according to current treatment guidelines.

    Discontinuation of treatment with bulevirtide can lead to reactivation of the HDV and HBV infection and exacerbation of hepatitis. In case of treatment discontinuation, liver function including transaminase levels, as well as HBV DNA and HDV RNA viral load should be performed.

    Discontinuation of treatment should be considered if there is a loss of response or if after 6 months there is still sustained hepatitis B surface antigen seroconversion.

    Pregnancy and Lactation

    Pregnancy

    Bulevirtide is contraindicated during pregnancy.

    The manufacturer advises that it is preferable to avoid the use of bulevirtide during pregnancy and in women of child-bearing potential not using contraception.

    Lactation

    Bulevirtide is contraindicated during breastfeeding.

    The manufacturer advises that a decision must be made whether to discontinue breastfeeding or to discontinue treatment with bulevirtide, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.

    Side Effects

    Anaphylactic reaction
    Arthralgia
    Dermatitis
    Dizziness
    Eosinophilia
    Erythema at injection site
    Exacerbation of hepatitis
    Fatigue
    Haematoma (injection site)
    Headache
    Hypersensitivity reactions
    Increase in bile salts
    Induration (injection site)
    Influenza-like symptoms
    Injection site reactions
    Local pain (injection site)
    Nausea
    Pruritus
    Rash at injection site

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2023

    Reference Sources

    Summary of Product Characteristics: Hepcludex 2mg powder for solution for injection. Gilead Sciences Ltd. Revised September 2022.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 January 2023

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