Molecule
Spesolimab is an interleukin-36 receptor antagonist 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. MedsAcross supplies Spesolimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. SPEVIGO is an interleukin-36 receptor antagonist 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Subcutaneous Dosage for Treatment of GPP When Not Experiencing a Flare Administer a subcutaneous loading dose of 600 mg, followed by 300 mg subcutaneously 4 weeks later and every 4 weeks thereafter. Subcutaneous Use After Intravenous SPEVIGO for Treatment of GPP Flare: Four weeks after treatment with intravenous SPEVIGO, initiate or reinitiate subcutaneous SPEVIGO at a dose of 300 mg administered every 4 weeks. A loading dose is not required following treatment of a GPP flare with intravenous SPEVIGO. See full prescribing information for preparation and administration instructions. Intravenous Dosage for Treatment of GPP Flare Must be diluted before intravenous use. Administer as a single 900 mg dose by intravenous infusion over 90 minutes. If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose.
Source: US FDA prescribing information
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. Severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO
Source: US FDA prescribing information
Infections: SPEVIGO may increase the risk of infections. Treatment with SPEVIGO is not recommended during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment. If a clinically important active infection develops, discontinue SPEVIGO until the infection resolves or is adequately treated. Risk of Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SPEVIGO. Hypersensitivity and Infusion-Related Reactions: Hypersensitivity reactions, including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS), and infusion-related reactions may occur. Discontinue SPEVIGO immediately and initiate appropriate treatment if a serious hypersensitivity reaction occurs.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: Infections Hypersensitivity and Infusion-Related Reactions Treatment of GPP When Not Experiencing a Flare: SPEVIGO has been associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus. Treatment of GPP Flare: The most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.
Source: US FDA prescribing information
Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light. Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days. 150 mg/mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Single-dose vials Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Spesolimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Spevigo 300 mg injectionIntravenous Cold chain | Boehringer Ingelheim Pharmaceuticals | US FDA | Available on request |
| Spevigo 300 mg/2 mL injectionSubcutaneous Cold chain | LEO Pharma | US FDA | Available on request |
| Spevigo 150 mg injectionIntravenous Cold chain | Boehringer Ingelheim Pharmaceuticals | US FDA | Available on request |
| Spevigo 150 mg/1 mL injectionSubcutaneous Cold chain | LEO Pharma | US FDA | Available on request |
| Spevigo 450 mg/7.5 mL injectionSubcutaneous Cold chain | LEO Pharma | US FDA | Available on request |
| Spevigo 450 mg/7.5 mL injectionIntravenous Cold chain | Boehringer Ingelheim Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 6 presentations of Spesolimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Spesolimab, including Spevigo.
Yes. The US FDA first approved Spesolimab on 1 September 2022, according to Drugs@FDA.
Yes. Spesolimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Spesolimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Spesolimab is classified under ATC code L04AC22 (Spesolimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.