Spesolimab
Spesolimab is a monoclonal antibody that blocks interleukin-36 (IL-36) signaling by binding to the IL-36 receptor. It is used to treat inflammatory conditions characterized by dysregulated IL-36 activity, primarily generalized pustular psoriasis (GPP). By preventing IL-36 ligand activation, it reduces the inflammatory cascade that drives these conditions.
Spesolimab is an IL-36 receptor antagonist antibody used to treat generalized pustular psoriasis by blocking inflammatory signaling.
Key facts at a glance
- ATC
- L04AC22
- RxNorm
- 2610417
- Generic
- Spesolimab
- Class
- atc-l04
- Brands
- Spevigo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 900mg as single infusion
- Maximum
- consult physician
- Frequency
- single dose, repeat at week 4 if needed
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 900mg as single infusion
- Maximum
- consult physician
- Frequency
- single dose, repeat at week 4 if needed (for patients ≥12 years and ≥40kg)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 900mg as single infusion
- Maximum
- consult physician
- Frequency
- single dose, repeat at week 4 if needed
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
11 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - discuss with healthcare provider
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
continue only if already receiving treatment and benefits outweigh risks
routine prenatal care
Use with caution and monitor for adverse effects.
pregnancy
third trimesterconsider discontinuation
discuss timing of last dose before delivery with healthcare provider
fetal monitoring in late pregnancy
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
discontinue breastfeeding or discontinue drug - limited data on excretion in breast milk
monitor infant for immune-related effects
geriatric
elderly 65no specific dose adjustment
use with caution - limited clinical trial data in elderly population
monitor for infections and immune-related adverse events
Use with caution and monitor for adverse effects.
pediatric_age
peds 0 12not recommended
not approved for use in children under 12 years - safety and efficacy not established
not applicable
pediatric_age
peds 12 18not recommended
not approved for use in patients under 18 years - limited safety data available
monitor growth and development if used
renal_impairment
mild renal impairmentno dose adjustment required
no dose adjustment needed for mild renal impairment
routine renal function monitoring
renal_impairment
moderate severe renal impairmentno specific guidance
use with caution - limited data available
monitor renal function during treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno dose adjustment required
no dose adjustment needed for mild hepatic impairment
routine liver function monitoring
hepatic_impairment
moderate severe hepatic impairmentnot recommended
not recommended for use - limited data available
monitor liver function tests
Statistics and clinical data
FDA approval year
FDA approval for treatment of generalized pustular psoriasis flares
Drug class
Biological drug classification
Primary indication
Therapeutic indication for acute flares in adults
Mechanism of action
Blocks IL-36 signaling to reduce inflammation
Spesolimab is primarily indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults. It may also be used for other conditions involving IL-36-mediated inflammation as determined by a healthcare provider.
Spesolimab is a humanized monoclonal antibody (IgG1) that specifically binds to the IL-36 receptor (IL36R). By blocking this receptor, it prevents activation by IL-36 ligands (IL-36α, β, and γ), thereby inhibiting the downstream inflammatory signaling cascade that contributes to pustular skin eruptions and systemic inflammation.
As an immunosuppressant, spesolimab may increase the risk of infections. It is administered as an intravenous infusion. Patients should be monitored for infusion-related reactions and infections during treatment. Not recommended during pregnancy unless clearly needed. Healthcare providers should complete appropriate patient selection and monitoring according to prescribing guidelines.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy