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Spevigo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vials—2
Manufacturer
Generic Availability
NO
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 cognate 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.
Spevigo Indications
Indications
Generalized pustular psoriasis (GPP) flares.
Spevigo Dosage and Administration
Adult
900mg as a single dose by IV infusion over 90mins. May give additional 900mg dose after 1 week if flare symptoms persist.
Children
Not established.
Spevigo Contraindications
Not Applicable
Spevigo Boxed Warnings
Not Applicable
Spevigo Warnings/Precautions
Warnings/Precautions
Increased risk of infections. Consider risks/benefits prior to initiating if chronic or history of recurrent infection. Latent or history of TB; consider anti-TB therapy prior to initiation. Evaluate for TB infection prior to initiation. Patients with active TB infection: do not initiate. Monitor for active TB during and after therapy. Discontinue immediately if anaphylaxis or other serious hypersensitivity develops (eg, DRESS). Interrupt and consider appropriate treatment if mild or moderate infusion-related reactions develop. Pregnancy. Nursing mothers.
Spevigo Pharmacokinetics
Distribution
The total volume of distribution at steady state was 6.4L.
Elimination
Half-life: 25.5 days.
Spevigo Interactions
Interactions
Avoid concomitant live vaccines.
Spevigo Adverse Reactions
Adverse Reactions
Asthenia, fatigue, nausea, vomiting, headache, pruritus, prurigo, infusion site hematoma, bruising, urinary tract infection; DRESS.
Spevigo Clinical Trials
See Literature
Spevigo Note
Not Applicable
Spevigo Patient Counseling
See Literature
