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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Interleukin inhibitors
spesolimab
L04AC22
Forms & Strengths
- Intravenous infusion: 450 mg/7.5 mL (60 mg/mL) single-dose vial
Adult Dosing
- Generalized pustular psoriasis (GPP) flare: 900 mg IV single infusion
- If flare persists, may repeat 900 mg IV once 1 week after initial dose
Pediatric Dosing
- Safety and efficacy in pediatric patients below 12 years of age or weighing less than 40 kg have not been established
- Adolescents >= 12 years weighing >= 40 kg: 900 mg IV single infusion for GPP flare (same as adult dosing)
Indications
- Treatment of generalized pustular psoriasis (GPP) flares in adults and pediatric patients aged 12 years and older weighing at least 40 kg
Mechanism of Action
- Humanized monoclonal antibody (IgG1 kappa) that selectively binds to the interleukin-36 receptor (IL-36R)
- Blocks IL-36 receptor signaling, thereby preventing IL-36-mediated pro-inflammatory and neutrophil-recruiting pathways involved in GPP pathogenesis
Contraindications
- Previous severe hypersensitivity reaction to spesolimab or any of its excipients
Adverse Reactions
- Infections (including urinary tract infections and upper respiratory tract infections)
- Injection site reactions
- Fatigue
- Nausea
- Headache
- Pruritus
- Hypersensitivity reactions including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS)
Drug Interactions
- Avoid concurrent administration of live vaccines with spesolimab
- CYP450 substrates: clearance of concurrent CYP substrates may be altered during chronic inflammation (theoretical consideration upon IL-36 inhibition)
Curated Content: Needs Vetting Before Put to Clinical Use