Belimumab
BENLYSTA
What it isMonoclonal antibody neutralizing B-cell activating factor; systemic lupus and active lupus nephritis.
Why this oneIt was the first biologic ever approved for lupus and trims flares and steroid need in autoantibody-positive disease.
What limits itEffect builds slowly over months, and it remains an add-on to standard immunosuppression. Serious infection and infusion reactions occur; monitor depression or suicidality and avoid live vaccines.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Active SLE (intravenous) | Adults & pediatric ≥5 yr | — | IV 10 mg/kg at weeks 0, 2, 4, then q4wk | — |
| Active SLE (subcutaneous) | Adults & pediatric ≥40 kg | — | SC 200 mg once weekly | — |
| Active SLE (subcutaneous) | Pediatric ≥5 yr, 15 to <40 kg | — | SC 200 mg once every 2 weeks | — |
| Active lupus nephritis (intravenous) | Adults & pediatric ≥5 yr | — | IV 10 mg/kg at weeks 0, 2, 4, then q4wk | — |
| Active lupus nephritis (subcutaneous) | Adults & pediatric ≥40 kg | 400 mg SC once weekly ×4 doses | then 200 mg SC once weekly | — |
| Active lupus nephritis (subcutaneous) | Pediatric ≥5 yr, 15 to <40 kg | 200 mg SC once weekly ×4 doses | then 200 mg SC once every 2 weeks | — |
Renal No adjustment needed
Hepatic No adjustment needed
Instructions
- IV: reconstitute and dilute, infuse over 1 h; do not give as IV push/bolus
- SC: inject in abdomen or thigh, rotate sites; patients <10 yr must be dosed by HCP/trained caregiver
- Consider premedication for infusion/hypersensitivity reactions (IV)
- Do not give live vaccines 30 days before or during treatment
Contraindications
- Prior anaphylaxis with belimumab
- Prior Stevens-Johnson syndrome or toxic epidermal necrolysis with belimumab
Cautions
- Serious and sometimes fatal infections
- Progressive multifocal leukoencephalopathy (PML)
- Hypersensitivity reactions including anaphylaxis
- Stevens-Johnson syndrome / toxic epidermal necrolysis
- Depression and suicidality
- Malignancy risk
- Avoid live vaccines
- Caution with other biologics/rituximab
Adverse reactions
- Nausea
- Diarrhea
- Pyrexia
- Nasopharyngitis
- Bronchitis
- Insomnia
- Pain in extremity
- Depression
- Migraine
- Pharyngitis
- Injection site reactions (SC)
Pregnancy Insufficient data; monoclonal antibody crosses placenta (3rd trimester); may affect infant immune response. Registry available.
Lactation No human milk data; maternal IgG present in human milk.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Belimumab ballicule
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