Anifrolumab
SAPHNELO
What it isA monoclonal antibody against the type I interferon receptor, given IV for systemic lupus erythematosus.
Why this oneIt directly suppresses the interferon signature central to lupus and is notably effective for cutaneous disease.
What limits itSerious infection, especially herpes zoster, can end treatment; avoid live vaccines. Its role in severe renal or CNS lupus is unestablished.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Moderate–severe SLE on standard therapy | Adults | — | IV 300 mg q4wk; or SC 120 mg once weekly | — |
Renal Undefined
Hepatic Undefined
Missed dose spacing: min 14 days between IV infusions; min 3 days between SC injections
Instructions
- IV: infuse over 30 min through in-line filter; SC: inject in thigh/abdomen, rotate sites
- Switching IV→SC: first SC ~2 wk after last IV; SC→IV: first IV ~3–4 wk after last SC
- Avoid live/live-attenuated vaccines
- Not recommended for use with other biologic therapies
Contraindications
- History of anaphylaxis with anifrolumab-fnia
Cautions
- Serious/fatal infections (respiratory, herpes zoster); avoid initiating during active infection
- Hypersensitivity reactions including anaphylaxis and angioedema
- Malignancy risk with immunosuppressants
- Avoid live/live-attenuated vaccines
- Not recommended with other biologic therapies
Adverse reactions
- Nasopharyngitis / upper respiratory tract infection
- Bronchitis
- Infusion-related reactions
- Herpes zoster
- Cough
Pregnancy Insufficient human data; monoclonal IgG crosses placenta (greater in 3rd trimester). Exposure registry available.
Lactation No human milk data; maternal IgG present in human milk.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Anifrolumab ballicule
