Spevigo- spesolimab-sbz
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kosar Doraghi, M.D.[2]
Kosar Doraghi, M.D.
Current Position
Associate Editor-in-Chief, Beth Israel Deaconess Medical Center by Harvard Medical School, Boston, Massachusetts, USA, WikiDoc Scholar
Pages Authored/Co-authored/Collaborated
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Black Box Warning
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Warning: Hypersensitivity and Infusion-Related Reactions, Infection
See full prescribing information for complete Boxed Warning.
Infections: SPEVIGO may increase the risk of infections. Do not initiate SPEVIGO during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur after treatment with SPEVIGO.
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Overview
Spevigo- spesolimab-sbz is an interleukin-36 receptor antagonis that is FDA approved for the treatment of generalized pustular psoriasis flares in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Administer as a single 900 mg dose by intravenous infusion over 90 minutes. If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose.
- If GPP flare symptoms persist, an additional intravenous 900 mg dose (over 90 minutes) may be administered one week after the initial dose.
Must be diluted before use. See full prescribing information for preparation and administration instructions and storage of the diluted solution
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Spevigo- spesolimab-sbz FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO
Warnings
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Warning: Hypersensitivity and Infusion-Related Reactions, Infection
See full prescribing information for complete Boxed Warning.
Infections: SPEVIGO may increase the risk of infections. Do not initiate SPEVIGO during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur after treatment with SPEVIGO.
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There is limited information regarding Spevigo- spesolimab-sbz Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Spevigo- spesolimab-sbz Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Spevigo- spesolimab-sbz Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Spevigo- spesolimab-sbz Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Spevigo- spesolimab-sbz in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spevigo- spesolimab-sbz in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Spevigo- spesolimab-sbz during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in geriatric settings.
Gender
There is no FDA guidance on the use of Spevigo- spesolimab-sbz with respect to specific gender populations.
Race
There is no FDA guidance on the use of Spevigo- spesolimab-sbz with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Spevigo- spesolimab-sbz in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Spevigo- spesolimab-sbz in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Spevigo- spesolimab-sbz Administration in the drug label.
Monitoring
There is limited information regarding Spevigo- spesolimab-sbz Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Spevigo- spesolimab-sbz and IV administrations.
Overdosage
There is limited information regarding Spevigo- spesolimab-sbz 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 Spevigo- spesolimab-sbz Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Spevigo- spesolimab-sbz Mechanism of Action in the drug label.
Structure
There is limited information regarding Spevigo- spesolimab-sbz Structure in the drug label.
Pharmacodynamics
There is limited information regarding Spevigo- spesolimab-sbz Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Spevigo- spesolimab-sbz Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Spevigo- spesolimab-sbz Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Spevigo- spesolimab-sbz Clinical Studies in the drug label.
How Supplied
There is limited information regarding Spevigo- spesolimab-sbz How Supplied in the drug label.
Storage
There is limited information regarding Spevigo- spesolimab-sbz Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Spevigo- spesolimab-sbz Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Spevigo- spesolimab-sbz 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 Spevigo- spesolimab-sbz Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Spevigo- spesolimab-sbz 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.