Spesolimab-sbzo (Monograph)

Brand name: Spevigo
Drug class:

Medically reviewed by Drugs.com on Mar 10, 2024. Written by ASHP.

Introduction

Interleukin-36 receptor inhibitor; recombinant humanized IgG₁ monoclonal antibody.

Uses for Spesolimab-sbzo

Generalized Pustular Psoriasis

Treatment of generalized pustular psoriasis flares in adults.

Guideline recommendations not currently available as spesolimab was approved after publication of American Academy of Dermatology/National Psoriasis Foundation guidelines on treatment of psoriasis.

Spesolimab-sbzo Dosage and Administration

General

Pretreatment Screening

Evaluate patients for tuberculosis (TB) infection. Consider initiating treatment of latent TB prior to initiation of spesolimab.

Patient Monitoring

Monitor patients for signs or symptoms of clinically important infection, including active TB, during and after treatment with spesolimab.

Administration

IV Administration

Administer as a continuous IV infusion after dilution.

Administer through an IV line containing a sterile, non-pyrogenic, low protein binding, in-line filter (pore size of 0.2 micron). A pre-existing IV line may be used.

Flush line with sterile 0.9% sodium chloride injection prior to and at end of infusion.

Do not administer other infusions via same IV access. Do not mix with other products.

Dilution

Must dilute before use.

To dilute, withdraw and discard 15 mL from a 100 mL container of sterile 0.9% sodium chloride injection. Slowly replace discarded volume with 15 mL of spesolimab-sbzo (complete contents from 2 vials of 450 mg/7.5 mL) and mix gently.

Use diluted solution immediately. If not administered immediately, refrigerate diluted solution at 2–8°C for no more than 4 hours and protect from light.

Rate of Administration

Administer over 90 minutes. If infusion is slowed or temporarily stopped, total infusion time (including stop time) should not exceed 180 minutes.

Dosage

Adults

Generalized Pustular Psoriasis

IV

Single dose of 900 mg by continuous IV infusion. If flare symptoms persist, may administer an additional 900 mg dose 1 week after initial dose.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Use

No specific dosage recommendations at this time.

Cautions for Spesolimab-sbzo

Contraindications

Severe or life-threatening hypersensitivity to spesolimab-sbzo or to any excipients.

Warnings/Precautions

Infections

May increase risk of infections.

In patients with chronic infection or history of recurrent infection, consider potential risks and benefits to prescribing spesolimab-sbzo. Treatment 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 clinically important infection occur.

Risk of Tuberculosis

Evaluate patients for TB infection prior to treatment. Do not administer to patients with active TB infection.

Consider initiating anti-TB therapy prior to initiating therapy in patients with latent TB or history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after treatment.

Hypersensitivity and Infusion-related Reactions

Hypersensitivity reactions may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS).

If patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue drug immediately and initiate appropriate treatment.

If patient develops mild or moderate infusion-related reactions, stop the infusion and consider appropriate medical therapy (e.g., systemic antihistamines and/or corticosteroids). Upon resolution, restart infusion at a slower infusion rate with gradual increase to complete the infusion.

Vaccinations

Avoid use of live vaccines in patients treated with spesolimab.

Immunogenicity

Anti-drug antibodies observed at a median onset of 2.3 weeks. Percentage of subjects with ADA titers >4000 was greater in females than males. No observed influence on spesolimab pharmacokinetics in patients with ADA titers <4000; however, in most of these patients, plasma spesolimab-sbzo concentrations were reduced.

Data limited on effect of antibodies on safety and efficacy upon retreatment.

Specific Populations

Pregnancy

Insufficient data in pregnant women to inform a drug-associated risk of adverse pregnancy-related outcomes. Human IgG is known to cross the placental barrier; therefore, spesolimab may be transmitted from the mother to developing fetus.

Lactation

No data on presence of spesolimab in human milk, effects on the breastfed infant, or effects on milk production. Expected to be present in human milk. Consider developmental and health benefits of breastfeeding along with mother's clinical need for spesolimab and any potential adverse effects on breastfed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Insufficient data in geriatric patients to determine whether they respond differently from younger adult subjects.

Hepatic Impairment

No formal studies in hepatic impairment. As a monoclonal antibody, spesolimab is not expected to undergo hepatic elimination.

Renal Impairment

No formal studies in renal impairment. As a monoclonal antibody, spesolimab is not expected to undergo renal elimination.

Common Adverse Effects

Common adverse reactions (≥5%): asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, urinary tract infection.

Drug Interactions

Metabolic pathway not studied; however, expected to be degraded into small peptides and amino acids via catabolic pathways similar to endogenous IgG.

No formal drug interactions studies conducted.

Vaccines

Avoid use of live vaccines in patients treated with spesolimab.

Spesolimab-sbzo Pharmacokinetics

Elimination

Metabolism

Expected to be degraded into small peptides and amino acids via catabolic pathways.

Half-life

25.5 days.

Special Populations

Age, gender, and race did not have an effect on pharmacokinetics.

Concentrations of spesolimab were lower in patients with higher body weight; however, clinical impact unknown.

Stability

Storage

Parenteral

Injection concentrate

2–8°C; protect from light. Do not freeze. Prior to use, unopened vials may be stored at 20–25°C for up to 24 hours in the original carton to protect from light.

Diluted solution

If not administered immediately, refrigerate diluted solution at 2–8°C for no more than 4 hours and protect from light.

Actions

Humanized recombinant immunoglobulin G₁ monoclonal antibody that binds specifically to the interleukin-36 receptor (IL-36R).
Binding of spesolimab to IL-36R prevents subsequent activation of IL-36R by cognate ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways.
Precise mechanism linking reduced IL-36R activity to treatment of generalized pustular psoriasis unclear.

Advice to Patients

Inform patients that spesolimab may lower the ability of their immune system to fight infections.
Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any signs or symptoms of clinically important infection.
Inform patients that hypersensitivity and infusion-related reactions may occur with spesolimab. Advise patients to seek immediate medical attention if they experience any symptoms of a serious hypersensitivity reaction.
Advise patients to avoid receiving live vaccines after treatment with spesolimab.
Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.
Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.