Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 450mg/7.5mL single-dose vial
Psoriasis
Indicated for the treatment of generalized pustular psoriasis (GPP) flares
900 mg IV as a single dose
If GPP flare persists, may administer an additional 900-mg dose 1 week after initial dose
Dosage Modifications
Renal or hepatic impairment
- As a monoclonal antibody, it is not expected to undergo hepatic or renal elimination
- No formal pharmacokinetic studies conducted
Dosing Considerations
Before initiating
- Evaluate for tuberculosis (TB) infection
- Do not initiate in patients with active TB infection
- Consider treating latent TB before initiating
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
spesolimab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
spesolimab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
spesolimab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
spesolimab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
spesolimab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
spesolimab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (0)
Minor (0)
Adverse Effects
1-10%
Asthenia and fatigue (9%)
Nausea and vomiting (9%)
Headache (9%)
Pruritus and prurigo (6%)
Infusion-site hematoma and bruising (6%)
Urinary tract infection (6%)
Bacteremia (3%)
Bacteriuria (3%)
Cellulitis (3%)
Herpes dermatitis and oral herpes (3%)
Upper respiratory tract infection (3%)
Dyspnea (3%)
Eye edema (3%)
Urticaria (3%)
Frequency Not Defined
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Injection site erythema, swelling, pain, induration, and warmth
Warnings
Contraindications
Hypersensitivity to spesolimab or excipients
Cautions
Infections
- May increase risk of infections
- Consider potential risk in patients with chronic infection or history of recurrent infection
- Not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated
- Instruct patients to seek medical advice if signs or symptoms of infection occurs after spesolimab treatment
Risk of tuberculosis (TB)
- Evaluate patients for TB infection before initiating
- Do not administer with active TB infection
- Consider initiating anti-TB therapy before starting spesolimab in patients with latent TB or history of TB in whom an adequate course of treatment cannot be confirmed
- Monitor for signs and symptoms of active TB during and after treatment
Hypersensitivity and infusion-related reactions
- Hypersensitivity reactions may include immediate reactions (eg, anaphylaxis) and delayed reactions (eg, drug reaction with eosinophilia and systemic symptoms [DRESS])
- DRESS reported during clinical trials
- Discontinue immediately if anaphylaxis or other serious hypersensitivity occurs; immediately initiate appropriate treatment
- If mode or moderate infusion-related reaction occurs, stop infusion and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids)
- Upon resolution, may restart infusion at slower rate and gradually increase to complete infusion
Drug interaction overview
-
Live vaccines
- Avoid use of live vaccines in patients treated with spesolimab, owing to potentially increased risk of infections
- Studies have not been conducted in spesolimab-treated patients who have recently received live viral or live bacterial vaccines
Pregnancy & Lactation
Pregnancy
Data regarding use pregnant females are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes
Human IgG crosses the placental barrier; therefore, spesolimab may be transmitted from mother to developing fetus
Animal studies
- IV administration of a surrogate antibody against IL36R in mice during organogenesis did not elicit any reproductive toxicity
Lactation
Data are not available on presence in human milk, effects on breastfed infants, or effects on milk production
Monoclonal antibodies are expected to be present in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Anti-interleukin-36 (IL-36) monoclonal antibody; binding to the IL-36 receptor decreases release of proinflammatory and profibrotic pathways in patients with inflammatory dermatoses
Absorption
Peak plasma concentration: 238 mcg/mL
AUC: 4,750 mcg⋅day/mL
Distribution
Vd (steady-state): 6.4 L
Metabolism
Metabolic pathway not characterized
As a humanized IgG1 monoclonal antibody, it is expected to degrade into small peptides and amino acids via catabolic pathways (like endogenous IgG)
Elimination
Half-life: 25.5 days
Administration
IV Incompatibilities
Do not mix with other medicinal products
Do not infuse other drugs concomitantly while using the same IV access line
IV Compatibilities
0.9% NaCl
Infusion sets
- Polyvinylchloride (PVC)
- Polyethylene (PE)
- Polypropylene (PP)
- Polybutadiene and polyurethane (PUR)
In-line filters
- Polyethersulfone (PES, neutral and positively charged)
- Positively charged polyamide (PA)
IV Preparation
Inspect vials visually for particulate matter and discoloration before administration
Solution should appear colorless to slightly brownish-yellow, clear to slightly opalescent; discard vial if solution is cloudy, discolored, or contains large or colored particulates
Draw and discard 15 mL from a 100-mL container of 0.9% NaCl
Slowly replace with 15 mL of spesolimab (complete contents from 2 vials of 450 mg/7.5 mL)
Mix gently before use
Use diluted solution immediately
IV Administration
Administer as continuous IV infusion over 90 minutes through an IV line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron)
If infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes
Pre-existing IV line may be used; must flush with 0.9% NaCl before and at end of infusion
Monitor for hypersensitivity or infusion-related reactions
Storage
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
- Do not freeze
- Before use, may store unopened vials at 20-25ºC (68-77ºF), for up to 24 hr in original carton to protect from light
Diluted solution
- If not used immediately, may refrigerate at 2-8ºC (36-46ºF) for up to 4 hr
- Protect from light
Images
Formulary
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