Belimumab 200mg/1ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Suspected adverse reactions reported for Belimumab
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Belimumab
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Belimumab on the MHRA register
Benlysta 200mg/1ml solution for injection pre-filled pens
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
Clinical guidelines and formulary information
British National Formulary
Belimumab
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(3)
Belimumab for treating active autoantibody-positive systemic lupus erythematosus (TA752)
Belimumab for treating lupus nephritis (terminated appraisal) (TA806)
Obinutuzumab with mycophenolate mofetil for treating lupus nephritis (TA1131)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
1.8 days
Mechanism
Systemic lupus erythematosus (SLE) and lupus nephritis, a common and serious man…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
74-82%
[A251500]…
Half-life
10 mg/k
Protein binding
Volume of distribution
10 mg/k
[L42630]…
Metabolism
[L42705]…
Elimination
Clearance
10 mg/k
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Belimumab was first approved by the FDA on March 9, 2011,[A251495] making it the newest drug to be approved for the treatment of SLE in more than 50 years.[A251520] It is currently used to treat SLE and lupus nephritis.[L42630]
[L42630]
In Europe, belimumab is also used to treat SLE and lupus nephritis but only in adults.
[L42705]
The efficacy of belimumab has not been evaluated in patients with severe active central nervous system lupus. Use of belimumab is not recommended in this situation.
[L42630]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 681 interactions
There is limited experience with overdosage of belimumab. Two doses of up to 20 mg/kg have been given intravenously to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.
[L42630]
In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriate[L42705]
Belimumab is an antibody directed against BLyS: it selectively binds BLyS with high affinity, neutralizes it, and blocks its interaction with B cell receptors - transmembrane activator and calcium-modulator and cyclophilin ligand interactor (TACI), B-cell maturation antigen (BCMA),[A251520] and BLyS receptor 3 (BR3).[A14436][A251520] Belimumab ultimately inhibits the survival of B cells, promotes apoptosis, and reduces the differentiation and maturation of B cells into immunoglobulin-producing plasma cells.[A14436][A251520][L42630]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A251500]
Following administration of 10 mg/kg belimumab via intravenous infusion in adults with SLE, the Cmax was 313 mcg/mL and the AUC0-∞ was 3,083 day x mcg/mL. Following subcutaneous administration of 200 mg belimumab once-weekly in adults with SLE, the Cmax was 108 mcg/mL and the AUC0-∞ was 726 day x mcg/mL.
[L42630]
In healthy Japanese volunteers, the Tmax was 6.5 days after administration of a single subcutaneous dose of 200 mg/mL belimumab.
[A251505]
Steady-state exposure was reached after approximately 11 weeks of subcutaneous administration in healthy subjects of patients with SLE.
[L42705]
[L42630]
[L42630]
[L42705]
[L42630]
Proteins and enzymes this drug interacts with in the body
A third B-cell specific BAFF-receptor (BAFFR/BR3) promotes the survival of mature B-cells and the B-cell response
ATC L04AG04
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Belimumab
Additional database identifiers
Drugs Product Database (DPD)
20836
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11929
GenAtlas
TNFSF13B
GeneCards
TNFSF13B
GenBank Gene Database
AF136293
GenBank Protein Database
4761612
UniProt Accession
TN13B_HUMAN
Patent information
All patents expired, 2 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: