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Belimumab powder for concentrate for solution for infusion

Updated 2 Feb 2023 | Belimumab


Infusions of belimumab.

These products have been produced by recombinant technology using mammalian cell line (NSO).

Drugs List

  • belimumab 120mg powder for concentrate for solution for infusion
  • belimumab 400mg powder for concentrate for solution for infusion
  • BENLYSTA 120mg powder for concentrate for solution for infusion
  • BENLYSTA 400mg powder for concentrate for solution for infusion
  • Therapeutic Indications


    Lupus erythematosus - systemic
    Lupus nephritis

    Adjunct therapy for treatment of active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (positive anti-dsDNA and low complement) despite standard therapy.

    In combination with background immunosuppressive therapies for the treatment of active lupus nephritis in adult patients.



    Systemic lupus erythematosus and lupus nephritis
    10mg/kg on days 0, 14 and 28, then every 4 weeks (28 days).

    In patients with systemic lupus erythematosus, consider discontinuation if there is no improvement in disease control after 6 months of treatment.
    In patients with acute lupus nephritis, belimumab should be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance.


    Systemic lupus erythematosus
    Children aged 5 to 18 years
    10mg/kg once every 2 weeks for 3 doses (on days 0, 14 and 28), then once every 4 weeks (28 days).

    Consider discontinuation if there is no improvement in disease control after 6 months of treatment.

    Lupus nephritis
    Belimumab is not licensed for lupus nephritis in patients below 18 years of age.


    After dilution given by intravenous infusion over 1 hour only.

    Transition from intravenous to subcutaneous administration
    Systemic lupus erythematosus
    The first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose.

    Lupus nephritis
    The first subcutaneous dose of 200mg should be administered 1 to 2 weeks after the last intravenous dose. This transition should occur any time after the patient completes the first 2 intravenous doses.


    Children under 5 years
    History of progenitor cell transplantation
    Organ transplant recipients
    Severe infection
    History of hepatitis B
    History of hepatitis C
    Immunoglobulin A deficiency
    Positive HIV status

    Precautions and Warnings

    Allergic disposition
    Children under 18 years
    History of recurrent infection
    History of neoplasm
    Latent or healed tuberculosis
    Malignant neoplasm
    Severe renal impairment

    Do not administer if live vaccine given within last 30 days
    Consider pneumococcal vaccination prior to starting treatment
    Pre-medicate with antihistamines with or without antipyretics
    Treatment to be initiated and supervised by a specialist
    Dilute and use as an infusion
    Record name and batch number of administered product
    Reduce infusion rate if mild to moderate infusion reaction occurs
    Resuscitation facilities must be immediately available
    Consider immunosuppressant adjustment in the event of PML
    Consider PTLD or PML if new or worsening neurological symptoms occur
    Monitor and discontinue if appropriate if psychiatric or CNS problems occur
    Monitor closely any patient who develops new infection while on treatment
    Monitor for hypersensitivity reactions-particularly 1st and 2nd infusions
    Monitor for mental changes, suicidal depression and antisocial behaviour
    Monitor retreated patients for symptoms of delayed hypersensitivity
    Advise patient of the risk of late onset adverse reactions
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Advise patients/carers to seek medical advice if changes in behaviour/mood
    Immunosuppressive drugs may increase risk of malignancy
    May affect immune response to live vaccines
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue permanently if life threatening infusion reactions occur
    Interrupt treatment if severe infusion reaction occurs
    Consider interrupting treatment if infection occurs
    Not licensed for all indications in all age groups
    Female: Contraception required during and for 4 months after treatment
    Advise patient to read the leaflet in the pack
    Advise patients that hypersensitivity reactions may be life threatening

    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

    Pregnancy and Lactation


    Belimumab is contraindicated during pregnancy.

    The manufacturer does not recommend using belimumab during pregnancy unless the potential benefit justifies the risk to the foetus. At the time of writing there is limited published information regarding the use of belimumab during pregnancy. Potential risks are unknown. However, except the expected pharmacological effect (reduced B cells), animal studies do not indicate reproductive toxicity.


    Belimumab is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues belimumab or discontinues breastfeeding. The presence of belimumab in human breast milk and the effects on exposed infants are unknown. However, animal data reports belimumab is present in breast milk. Belimumab is a large protein molecule with a molecular weight of 147,000, the amount in milk is likely to be very low. Absorption is unlikely as it is probably destroyed in the infants gastrointestinal tract. LactMed (2015) suggest belimumab is not a reason to discontinue with breastfeeding but should be used with caution.

    Side Effects

    Delayed hypersensitivity reactions
    Facial oedema
    Hypersensitivity reactions including anaphylaxis
    Increased risk of neoplasms
    Increased susceptibility to infection
    Infusion-related symptoms
    Injection site reactions
    Painful extremities
    Progressive multifocal leukoencephalopathy (PML)
    Psychiatric disorders
    Suicidal tendencies
    Upper respiratory tract infection
    Urinary tract infections


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2019

    Reference Sources

    Summary of Product Characteristics: Benlysta 120mg and 400mg powder for concentrate for solution for infusion. GlaxoSmithKline UK Ltd. Revised July 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Belimumab Last revised: 03 December 2018
    Last accessed: 22 May 2019

    NICE Evidence Services Available at: Last accessed: 07 June 2019

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