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Bimekizumab parenteral

Presentation

Injections of bimekizumab.

Drugs List

  • bimekizumab 160mg/1ml solution for injection pre-filled device
  • bimekizumab 160mg/1ml solution for injection pre-filled syringe
  • BIMZELX 160mg/1ml solution for injection pre-filled pen
  • BIMZELX 160mg/1ml solution for injection pre-filled syringe
  • Therapeutic Indications

    Uses

    Moderate to severe plaque psoriasis

    Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

    Dosage

    Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of plaque psoriasis.

    Adults

    320mg (2 injections of 160mg) at week 0, 4, 8, 12, 16 and every 8 week thereafter.

    Consider discontinuation of treatment in patients who show no response after 16 weeks of treatment.

    Additional Dosage Information

    Overweight patients
    For patients with a bodyweight greater than or equal to 120kg and who did not achieve complete skin clearance at week 16, 320mg every 4 weeks after week 16 may further improve treatment response.

    Administration

    For subcutaneous injection only.

    Bimekizumab is administered into the thigh, abdomen and upper arm.

    Contraindications

    Children under 18 years
    Severe infection
    Breastfeeding
    Pregnancy
    Tuberculosis

    Precautions and Warnings

    Chronic infection
    Females of childbearing potential
    History of recurrent infection
    Inflammatory bowel disease
    Latent or healed tuberculosis

    Administration of live vaccines is not recommended
    Consider prophylactic anti-tuberculosis therapy if appropriate
    Prior to starting therapy screen for latent tuberculosis
    Treat and control infections prior to commencing therapy
    Treatment to be initiated and supervised by a specialist
    Contains polysorbate
    Avoid injection into broken or bruised skin
    For subcutaneous use only
    Record name and batch number of administered product
    Self-admin. - only if adequately trained and have access to expert advice
    Vary injection site during prolonged therapy
    Discontinue if signs and symptoms of inflammatory bowel disease occur
    Monitor patient for signs of serious infection
    Advise patient to report symptoms of infection immediately
    Risk of developing opportunistic infections
    Discontinue if allergic reaction occurs
    Discontinue if no response to treatment after 16 weeks
    Interrupt treatment if severe infection develops
    Female: Contraception required during and for 17 weeks after treatment

    Pregnancy and Lactation

    Pregnancy

    Bimekizumab is contraindicated during pregnancy.

    The manufacturer recommends that it is preferable to avoid the use of bimekizumab during pregnancy. There is limited data regarding the use of bimekizumab. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.

    Lactation

    Bimekizumab is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues breastfeeding or discontinues bimekizumab. It is unknown whether bimekizumab is excreted in human breast milk. A risk to the infant cannot be excluded.

    Side Effects

    Acne
    Anaphylactic reaction
    Candida mucocutaneous
    Candidiasis (mouth or throat)
    Conjunctivitis
    Dermatitis
    Ear infection
    Eczema
    Fatigue
    Folliculitis
    Gastro-enteritis
    Headache
    Herpes simplex
    Hypersensitivity reactions
    Infections
    Inflammatory bowel disease
    Injection site reactions
    Neutropenia
    Oropharyngeal candidiasis
    Tinea infections
    Upper respiratory tract infection

    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: October 2021

    Reference Sources

    Summary of Product Characteristics: Bimzelx 160mg solution for injection in pre-filled pen. UCB Pharma Limited. Revised August 2021.

    Summary of Product Characteristics: Bimzelx 160mg solution for injection in pre-filled syringe. UCB Pharma Limited. Revised August 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.