Spesolimab-Sbzo (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INTRAVENOUS.
Brand Names
- SPEVIGO
Indications and Usage
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
Contraindications
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis [see Warnings and Precautions (5.3) and Adverse Reactions (6)].
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1)] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3)]
Mechanism of Action
Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. The precise mechanism linking reduced IL36R activity and the treatment of flares of GPP is unclear.