spesolimab (Rx)

Brand and Other Names:Spevigo, spesolimab-sbzo

Dosing & Uses

AdultPediatric

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

Next:

Interactions

Interaction Checker

and spesolimab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            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)

                  Previous
                  Next:

                  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

                  Previous
                  Next:

                  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
                  Previous
                  Next:

                  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.

                  Previous
                  Next:

                  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

                  Previous
                  Next:

                  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
                  Previous
                  Next:

                  Images

                  No images available for this drug.
                  Previous
                  Next:

                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
                  Previous
                  Next:

                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                  Additional Offers
                  Email to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Email Forms to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Previous
                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.