1. Indications and Usage
\nGPP Flares: Treatment of adult and pediatric patients (\u226512 years of age and \u226540 kg) with Generalized Pustular Psoriasis (GPP) flares.
\nPrevention of GPP Flares: Treatment of adult and pediatric patients (\u226512 years of age and \u226540 kg) with GPP to prevent flares.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor GPP Flares: For Intravenous (IV) Infusion ONLY.
\nFor Prevention of Flares: For Subcutaneous Injection ONLY.
\nRecommended Dosage:
\nGPP Flares (IV):
\nDose: 900 mg administered as a single intravenous infusion over 90 minutes.
\nRetreatment: If the GPP flare symptoms persist, a second dose of 900 mg may be administered 1 week after the first dose.
\nPrevention of GPP Flares (SC):
\nLoading Dose: 600 mg (administered as four 150 mg injections) at Week 0.
\nMaintenance Dose: 300 mg (administered as two 150 mg injections) 4 weeks after the loading dose, and then every 4 weeks thereafter.
\nInitiation after IV Treatment: If treated with IV infusion for a flare, initiate\/subcutaneous treatment 4 weeks after the IV dose.
\n3. Mechanism of Action
\nIL-36 Receptor Antagonist:
\nSpesolimab is a humanized IgG1 monoclonal antibody that binds specifically to the IL-36 receptor (IL-36R).
\nBlocking Signaling:
\nBy binding to IL-36R, spesolimab inhibits IL-36 signaling. Since IL-36 is a cytokine found upstream of IL-17 and TNF-\u03b1 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.
\n4. Safety and Warnings
\nSerious Infections:
\nSpesolimab 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.
\nHypersensitivity and Infusion-Related Reactions:
\nHypersensitivity 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.
\nVaccinations:
\nAvoid administration of live vaccines during treatment.
\n5.Adverse Reactions
\nMost Common:
\nFor GPP flares (IV): Infusion-related reactions, nasopharyngitis, headache, pruritus, vomiting, and nausea.
\nFor Prevention (SC): Injection site reactions, nasopharyngitis, headache, and arthralgia.
\n6.Drug Interactions
\nLive Vaccines:
\nAvoid concurrent use with live vaccines.
\nOther Immunosuppressants:
\nSafety and efficacy in combination with other immunosuppressants have not been established.
\n7.Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Spesolimab-sbzo.
\nAvailable Strength:
\nIV: 450 mg\/7.5 mL (60 mg\/mL) in a single-dose vial.
\nSC: 150 mg\/mL in a pre-filled syringe or pen.
\nStorage: Store at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F) in the original carton to protect from light.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u00a0 \u5723\u5229\u5353 \u00ae(Spevigo\u00ae)
\nGeneric Name: Spesolimab
\nStrength: 450 mg\/7.5 mL per vial
\nManufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG
\nMarketing Authorization Holder: Boehringer Ingelheim International GmbH
\nApproval Date in China: December 14, 2022
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 SJ20220020
\nStorage: Store under refrigeration at 2\u20138\u00b0C (36\u201346\u00b0F). Do not freeze. Keep the vial in the outer carton to protect from light. Once diluted for infusion, the solution must be used within the specified time frame as outlined in the prescribing information. Refer to the full package insert for detailed storage and handling instructions.<\/p>\n
Price&Cost:Contact Us now for the best price of Spesolimab (Spevigo\uff09<\/p>\n","protected":false},"featured_media":4040,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[88],"product_cat":[25],"product_tag":[],"class_list":["post-4039","product","type-product","status-publish","has-post-thumbnail","product_brand-boehringer","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n