Spevigo Spesolimab Injection

1. Indications and Usage
GPP Flares: Treatment of adult and pediatric patients (≥12 years of age and ≥40 kg) with Generalized Pustular Psoriasis (GPP) flares.
Prevention of GPP Flares: Treatment of adult and pediatric patients (≥12 years of age and ≥40 kg) with GPP to prevent flares.
2. Dosage and Administration
Route of Administration:
For GPP Flares: For Intravenous (IV) Infusion ONLY.
For Prevention of Flares: For Subcutaneous Injection ONLY.
Recommended Dosage:
GPP Flares (IV):
Dose: 900 mg administered as a single intravenous infusion over 90 minutes.
Retreatment: If the GPP flare symptoms persist, a second dose of 900 mg may be administered 1 week after the first dose.
Prevention of GPP Flares (SC):
Loading Dose: 600 mg (administered as four 150 mg injections) at Week 0.
Maintenance Dose: 300 mg (administered as two 150 mg injections) 4 weeks after the loading dose, and then every 4 weeks thereafter.
Initiation after IV Treatment: If treated with IV infusion for a flare, initiate/subcutaneous treatment 4 weeks after the IV dose.
3. Mechanism of Action
IL-36 Receptor Antagonist:
Spesolimab is a humanized IgG1 monoclonal antibody that binds specifically to the IL-36 receptor (IL-36R).
Blocking Signaling:
By binding to IL-36R, spesolimab inhibits IL-36 signaling. Since IL-36 is a cytokine found upstream of IL-17 and TNF-α that is predominantly involved in the pathogenesis of GPP, blocking this pathway reduces the release of proinflammatory cytokines and chemokines, thereby inhibiting the inflammatory cascade responsible for neutrophil recruitment and pustule formation.
4. Safety and Warnings
Serious Infections:
Spesolimab may increase the risk of infections. Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy. If an active infection occurs, discontinue spesolimab until the infection resolves or is adequately treated.
Hypersensitivity and Infusion-Related Reactions:
Hypersensitivity reactions, including angioedema and DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms), have been reported. Infusion-related reactions may occur during or after IV administration.
Vaccinations:
Avoid administration of live vaccines during treatment.
5.Adverse Reactions
Most Common:
For GPP flares (IV): Infusion-related reactions, nasopharyngitis, headache, pruritus, vomiting, and nausea.
For Prevention (SC): Injection site reactions, nasopharyngitis, headache, and arthralgia.
6.Drug Interactions
Live Vaccines:
Avoid concurrent use with live vaccines.
Other Immunosuppressants:
Safety and efficacy in combination with other immunosuppressants have not been established.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Spesolimab-sbzo.
Available Strength:
IV: 450 mg/7.5 mL (60 mg/mL) in a single-dose vial.
SC: 150 mg/mL in a pre-filled syringe or pen.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.