Belimumab powder for concentrate for solution for infusion
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusions of belimumab.
These products have been produced by recombinant technology using mammalian cell line (NSO).
Lupus erythematosus - systemic
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.
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.
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
History of hepatitis B
History of hepatitis C
Immunoglobulin A deficiency
Positive HIV status
Precautions and Warnings
Children under 18 years
History of recurrent infection
History of neoplasm
Latent or healed tuberculosis
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.
Delayed hypersensitivity reactions
Hypersensitivity reactions including anaphylaxis
Increased risk of neoplasms
Increased susceptibility to infection
Injection site reactions
Progressive multifocal leukoencephalopathy (PML)
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2019
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: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Belimumab Last revised: 03 December 2018
Last accessed: 22 May 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 June 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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