Prescription medicine
Spesolimab Brand names: Spevigo
Spesolimab (Spevigo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the spesolimab FDA label on DailyMed (effective April 8, 2026); every spesolimab label on DailyMed.
Highlights of the record
FDA label of April 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSPEVIGO 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.
Forms and strengths
- 150 mg
- 300 mg
- 60 mg/ml
- 150 mg/ml
- 300 mg/2ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 371 through July 30, 2026
What is spesolimab used for?
From the label: indications and usageSPEVIGO 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.
Conditions named in the indications of spesolimab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-36 Receptor Antagonist.
Source: FDA drug label (SPEVIGO), Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 2026 (SPL set 41a481ee-3062-45d1-aed5-17e8b105634d), via openFDA; the full label on DailyMed
What does the patient leaflet for spesolimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SPEVIGO?SPEVIGO may cause serious side effects, including: Infections. SPEVIGO may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you or your child for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO, including: fevers, chills, or sweats muscle aches cough shortness of breath blood in your phlegm (mucus) burning when you urinate urinating more often than normal Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child's SPEVIGO injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you or your child are given SPEVIGO in a vein (intravenously) and have an infusion-related reaction, your healthcare provider will stop your or your child's SPEVIGO infusion and treat your or your child's symptoms and may restart SPEVIGO at a slower infusion rate. […]
From the patient leaflet: How should I store SPEVIGO?Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze SPEVIGO. Do not use SPEVIGO if frozen, even if it has been thawed. Store SPEVIGO in the original carton until use to protect from light. If needed, SPEVIGO 300 mg/2 mL prefilled syringes may also be stored at room temperature up to 77°F (25°C) for up to 14 days. Throw away (dispose of) SPEVIGO 300 mg/2 mL prefilled syringes that have been left at room temperature for more than 14 days. Keep SPEVIGO and all medicines out of the reach of children.
Source: FDA drug label (SPEVIGO), Boehringer Ingelheim Pharmaceuticals, Inc., effective April 8, 2026 (SPL set 41a481ee-3062-45d1-aed5-17e8b105634d), via openFDA; the full label on DailyMed
Is there a generic for spesolimab (Spevigo)?
No generic spesolimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for spesolimab?
The FDA Adverse Event Reporting System holds 371 reports that list spesolimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 81 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as spesolimab?
2 other medicines are given the same way (intravenous) and in the same FDA class as spesolimab or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Risankizumab | Psoriasis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Secukinumab | Psoriasis | none listed | $3,946.35 per mL 300 mg dose/2 pens (150 mg/pen) | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Spesolimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other