Anifrolumab-Fnia (1 brand name, 3 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, VIAL, INJECTION.
Routes of administration: INJECTION, SINGLE-USE.
Brand Names
- SAPHNELO
Indications and Usage
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
Contraindications
SAPHNELO is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see Warnings and Precautions (5.2)].
Adverse Reactions
The following clinically significant adverse reactions are also discussed elsewhere in the labeling: •Serious Infections [see Warnings and Precautions (5.1)] •Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.2)] •Malignancy [see Warnings and Precautions (5.3)]
Drug Interactions
No formal drug interaction trials have been conducted.
Mechanism of Action
Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to subunit 1 of the type I interferon receptor (IFNAR) with high specificity and affinity. This binding inhibits type I IFN signaling, thereby blocking the biologic activity of type I IFNs. Anifrolumab-fnia also induces the internalization of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signaling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets. Type I IFNs play a role in the pathogenesis of SLE. Approximately 60-80% of adult patients with active SLE express elevated levels of type I IFN inducible genes.