Anti-BLyS Monoclonal Antibody (B-cell Inhibitor)
Pregnancy: C
Belimumab
Brand names: Benlysta
Adult dose
Dose: 10 mg/kg IV at weeks 0, 2, 4 then every 4 weeks; or 200 mg SC once weekly
Route: IV infusion or subcutaneous
Frequency: Monthly (IV) or weekly (SC)
Max: 200 mg/week SC or 10 mg/kg/month IV
IV infused over 1 hour; assess clinical response at 6 months — discontinue if no improvement; licensed for SLE
Paediatric dose
Dose: 10 mg/kg
Route: IV
Frequency: every 4 weeks
Max: 10 mg/kg
Concentration: 120 mg/mL or 200 mg/mL (SC); 120 mg or 400 mg vials (IV) mg/ml
Licensed ≥5 years for paediatric SLE (IV form only); same dosing as adults
Dose adjustments
Renal
No dose adjustment required
Hepatic
No dose adjustment required
Paediatric weight-based calculator
Licensed ≥5 years for paediatric SLE (IV form only); same dosing as adults
Clinical pearls
- First biologic licensed specifically for SLE in 50+ years
- BLISS-52 and BLISS-76 trials: reduced SLE flares and reduced steroid use
- Monitor mental health — depression/suicidality signal in clinical trials; assess at each visit
Contraindications
- Active severe infections
- Live vaccines (CI)
- Not for use in severe active lupus nephritis initially (limited data)
Side effects
- Infections (URTIs, UTIs)
- Nausea
- Diarrhoea
- Infusion/injection site reactions
- Depression/suicidality (monitor)
- Hypersensitivity
Interactions
- Live vaccines (CI — avoid for 30 days before/during therapy)
- Other biologics (avoid concurrent)
Monitoring
- SLEDAI/BILAG disease activity scores
- FBC
- Renal function
- Mental health assessment
Reference: BNFc; BNF 86; NICE TA397; BLISS trials. Verify against your local formulary and the latest BNF before prescribing.
Related
Curated clinical cross-links plus same-class fallbacks.
Calculators
- SMART Risk Score for Recurrent CVD · Cardiovascular Risk
- PCSK9 Inhibitor Eligibility Assessment · Lipid Management
- C-Peptide to Glucose Ratio · Diabetes Classification
- IMDC (Heng) Score for Metastatic RCC · Renal Cell Carcinoma
- Revised Original International Autoimmune Hepatitis Score (IAIHG) · Autoimmune Liver Disease
- Immune-Related Adverse Events (irAE) -- GI Toxicity Colitis Grading · Oncology-Related GI
Pathways
- Cutaneous Lupus Erythematosus · BAD; EULAR
- Osteoporosis / Fragility Fracture · NOGG 2021; NICE NG147; NG224
- Arteritic AION (Giant Cell Arteritis) · RCOphth; BSR
- Osteoarthritis Hip / Knee Management · NICE NG226 (2022)
- Lupus Nephritis · EULAR/ERA-EDTA 2019; KDIGO 2024
- Rheumatoid Arthritis Management · NICE CG79 2018 / EULAR 2022