Spesolimab-sbzo
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Spesolimab-sbzo is a humanized monoclonal Immunoglobulin G1 antibody that is FDA approved for the treatment of generalized pustular psoriasis (GPP) flares in adults.. Common adverse reactions include infections, nausea, vomiting, headache, fatigue, Infusion site hematoma and bruising..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults.
SPEVIGO is administered as a single 900 mg dose by intravenous infusion over 90 minutes. However, an additional intravenous 900 mg dose is administered over 90 minutes after one week of the initial dose, if the GPP persists.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of SPEVIGO in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Contraindications
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo such as anaphlaxis and DRESS syndrome. It is also contraindicated in patients active infections.
Warnings
- Infection
SPEVIGO increases the risk of infection. Therefore, Patients with clinicaly active infection are advised to avoid SPEVIGO, until the infection is adequately treated or resolved.
- Risk of tuberculosis
Evaluate the patient for tuberculosis infection. Avoid SPEVIGI in patients with tuberculosis. Patients should be started with anti-TB treatment before SPEVIGO if they have latent TB or a history of inadequate treatment course of TB.
- Hypersensitivity and infusion relation reaction
SPEVIGO may be associated with two serious life-threatening hypersensitivity reactions- immediate anaphylaxis reaction and delayed reaction- DRESS syndrome In either situation, immediately discontinue SPEVIGO and initiate appropriate management. Patients may also develop mild-moderate infusion related reaction. In such a situation, withhold the SPEVIGO infusion and administer appropriate medical therapy like systemic antihistamines and/or corticosteroids. Once the reactions have subsided, restart the infusion at a slower rate gradually.
- Vaccination
Avoid the use of live vaccines in patients treated with SPEVIGO.
Adverse Reactions
Clinical Trials Experience
- Asthenia and Fatigue
- Nausea and Vomiting
- Headache
- Pruritus and prurigo
- Infusion site hematoma and bruising
- Urinary tract infection
- Bacteremia
- Bacteriuria
- Upper respiratory tract infection
- Cellulitis
- Herpes dermatitis and oral herpes
- Urticaria
- Dyspnea
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Anaphylaxis
- Among approximately 750 subjects exposed to SPEVIGO during clinical development, Guillain-Barre syndrome (GBS) was reported in 3 subjects.
Postmarketing Experience
There is limited information regarding Spesolimab-sbzo Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Spesolimab-sbzo Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): B
The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.
However, since Human Immunoglobulin-G is transmitted to the fetus via the placenta, SPEVIGO may be transmitted from the mother to the developing fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spesolimab-sbzo in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Spesolimab-sbzo during labor and delivery.
Nursing Mothers
There are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. Spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk.
Pediatric Use
safety and effectiveness of SPEVIGO in pediatric patients have not been established.
Geriatic Use
Clinical studies of SPEVIGO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects.
Gender
There is no FDA guidance on the use of Spesolimab-sbzo with respect to specific gender populations.
Race
There is no FDA guidance on the use of Spesolimab-sbzo with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Spesolimab-sbzo in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Spesolimab-sbzo in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Spesolimab-sbzo in women of reproductive potentials and males.
Immunocompromised Patients
Since the SPEVIGO increases the risk of infection, it is best advised to avoid its use among patients who are immunocompromised or who are currently on immunosuppressants.
Administration and Monitoring
Administration
Recommended dose SPEVIGO is administered as a single dose infusion of, 900mg over 90 mins and if the GPP persist, we have to administer another 900mg over 90 mins after one week of initial dose.
Preparation and Administration
SPEVIGO must be diluted before its use. SPEVIGO is a colorless to slightly brownish-yellow, clear to slightly opalescent solution, and the vial should be discarded if the solution is cloudy, discolored, or contains large or colored particulates.
Preperation instructions:
- prepare the solution infusion with an aseptic technique
- draw and discard 15ml from a 100ml container of 0.9% Sodium chloride sterile
- replace the 15ml slowly with SPEVIGO and gently mix it.
- immediatly is the solution.
Administration instruction:
- Do not mix SPEVIGO with other medicinal products.
- Administer SPEVIGO as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter with pore size of 0.2 micron over 90 minutes. The infusion be completed within 180 min if the rate is slowed.
- A pre-existing intravenous line may be used for administration of SPEVIGO, however, the line must be flushed with sterile 0.9% Sodium Chloride Injection before and at the end of infusion.*Only via IV infusion.
Monitoring
the diluted solution is refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 4 hours if the solution is not used immediately. Protect from light.
IV Compatibility
No incompatibilities have been observed between SPEVIGO and infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA).
Overdosage
There is limited information regarding Spesolimab-sbzo overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Spesolimab-sbzo Pharmacology in the drug label.
Mechanism of Action
Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody inhibiting interleukin-36 (IL-36) signaling by binding to the IL36R, which prevents the subsequent activation of IL36R by cognate ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways
Structure
There is limited information regarding Spesolimab-sbzo Structure in the drug label.
Pharmacodynamics
The pharmacodynamics of SPEVIGO in the treatment of patients with GPP have not been fully characterized.
Pharmacokinetics
There is limited information regarding Spesolimab-sbzo Pharmacokinetics in the drug label.
Nonclinical Toxicology
Carcinogenicity and mutagenicity studies have not been conducted with spesolimab-sbzo. No adverse effects on fertility were observed in male or female mice that were intravenously administered a surrogate antibody to IL36R at doses up to 50 mg/kg twice weekly.
Clinical Studies
A randomized, double-blind, placebo-controlled study -Study Effisayil-1 [NCT03782792] was conducted to evaluate the clinical efficacy and safety of SPEVIGO in adult subjects with flares of generalized pustular psoriasis (GPP). Subjects were randomized if they had a flare of GPP of moderate-to-severe intensity, which was defined by:
- Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score of at least 3 (moderate) [the total GPPPGA score ranges from 0 (clear) to 4 (severe)],
- The presence of fresh pustules (new appearance or worsening of pustules),
- GPPPGA pustulation sub score of at least 2 (mild), and
- At least 5% of body surface area covered with erythema and the presence of pustules.
A total of 53 subjects were randomized (2:1) to receive a single intravenous dose of 900 mg SPEVIGO (N=35) or placebo (N=18) which was administered over 90 minutes, during the double-blind portion of the study. The study population consisted of 32% men and 68% women. The mean age was 43 years (range: 21 to 69 years); 55% of subjects were Asian and 45% were White. Most subjects included in the study had a GPPPGA pustulation sub score of 3 (43%) or 4 (36%), and subjects had a GPPPGA total score of 3 (81%) or 4 (19%). The results of the primary endpoint (GPPPGA Pustulation Sub Score at Week 1 in Study Effisayil-1) are:
- SPEVIGO subjects who achieved GPPPGA pustulation subscore 0 are 19
- Placebo subjects who achieved GPPPGA pustulation subscore 0 are 1
This study did not include sufficient numbers of subjects to determine if there are differences in response according to biological sex, age, race, baseline GPPPGA pustulation sub score, and baseline GPPPGA total score.
How Supplied
There is limited information regarding Spesolimab-sbzo How Supplied in the drug label.
Storage
There is limited information regarding Spesolimab-sbzo Storage in the drug label.
Images
Drug Images
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Patient Counseling Information
There is limited information regarding Spesolimab-sbzo Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Spesolimab-sbzo interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Spesolimab-sbzo Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Spesolimab-sbzo Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.