Use and Dosing ⬇
Adult Dosing
- 300 mg IV, over a 30-minute period, every 4 weeks.
Indications ⬆ ⬇
- Moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy (adult patients)
Contraindications ⬆ ⬇
- A history of anaphylaxis with anifrolumab-fnia.
- Concomitant use with other biologic therapies, including B-cell-targeted therapies.
- Chronic infection, a history of recurrent infections, or known risk factors for infection.
Warnings/Precautions ⬆ ⬇
- Serious and sometimes fatal infections
- Serious hypersensitivity reactions (including anaphylaxis)
- Risk factors for the development or reoccurrence of malignancy
- Avoid concurrent use of live or live-attenuated vaccines
Adverse Reactions ⬆ ⬇
- Serious Infections
- Hypersensitivity Reactions Including Anaphylaxis and Angioedema
- Malignancy
- Herpes Zoster
- Infusion-related Reactions
Clinical Pharmacology ⬆ ⬇
- Metabolism/Excretion: Unknown.
- Mechanism of Action: binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. Binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs
- Half-life: Unknown.
Brands and Availability ⬆ ⬇
US Trade Name(s)
US Availability
Saphnelo
- Solution for INJ: 150 mg/mL
Classification ⬆
Allergy & Immunology
Antibodies; Monoclonal