belimumab
Benlysta · ATC code L04AG04
- Key facts
- Active substance
- belimumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AG04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Benlysta 200 mg solution for injection in pre-filled pen. · Benlysta 200 mg solution for injection in pre-filled syringe. · Benlysta 120 mg powder for concentrate for solution for infusion. / Benlysta 400 mg powder for concentrate for solution for infusion.
- Marketing authorisation holder
- GlaxoSmithKline (Ireland) Limited
- Information as of
- 2026-10-28
Key facts
Belimumab (Benlysta) is a monoclonal antibody used as add-on therapy for active systemic lupus erythematosus (SLE) and for active lupus nephritis.
What it is used for
- Add-on therapy in active, autoantibody-positive SLE with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy – infusion and pre-filled pen from 5 years of age, pre-filled syringe in adults.
- In combination with background immunosuppressive therapies in adults with active lupus nephritis.
Dosing
- Subcutaneous, SLE in adults (pen/syringe): 200 mg once weekly, not weight-based.
- Subcutaneous, SLE in children and adolescents aged 5 to less than 18 years (pen): ≥ 50 kg 200 mg once weekly; 30 to < 50 kg 200 mg every 10 days; 15 to < 30 kg 200 mg every 2 weeks.
- Subcutaneous, lupus nephritis in adults (initiating): 400 mg (two 200 mg injections) once weekly for 4 doses, then 200 mg once weekly.
- Intravenous (SLE or lupus nephritis): 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.
- In SLE, consider discontinuation if there is no improvement in disease control after 6 months. Elderly: no dose adjustment, but use with caution.
- First subcutaneous injection under healthcare professional supervision; for transition from intravenous to subcutaneous use see the full text.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Not studied and not recommended in severe active CNS lupus, HIV, history of or current hepatitis B or C, hypogammaglobulinaemia (IgG < 400 mg/dL) or IgA deficiency (IgA < 10 mg/dL), or after major organ, stem cell/marrow or renal transplant.
- Hypersensitivity and infusion reactions, which can be severe and fatal; risk is greatest with the first two doses.
- Depression and suicidality were reported more frequently; assess risk before and monitor during treatment.
- Infections including progressive multifocal leukoencephalopathy (PML); suspend therapy until PML is excluded.
- Live vaccines should not be given for 30 days before or concurrently; data do not support co-administration with rituximab.
Side effects
- In SLE, the most frequently reported reaction (≥ 5% and ≥ 1% greater than placebo) was nasopharyngitis.
- In active lupus nephritis, the most frequent (> 5%) were upper respiratory tract infection, urinary tract infection and herpes zoster.
- Injection site reactions (6.1% with subcutaneous use), mostly mild to moderate.
- Severe cutaneous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported; also hypersensitivity reactions and psychiatric disorders.
Interactions
- No in vivo studies; indirect reduction of CYP activity cannot be excluded – consider monitoring of narrow-therapeutic-index CYP substrates (e.g. warfarin) when starting or stopping belimumab.
Pregnancy and breastfeeding
- Women of childbearing potential must use effective contraception during treatment and for at least 4 months after the last treatment.
- Should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- BenlystaGlaxoSmithKline (Ireland) Limited · EMEA/H/C/002015
Source: European Medicines Agency (EMA), product information
Turkey
- BenlystaGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Benlysta
- Liechtenstein
- Benlysta
- Norway
- Benlysta
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Benlysta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/benlysta-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AG.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.