Spevigo- spesolimab-sbz

Spevigo- spesolimab-sbz
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kosar Doraghi, M.D.[2]

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Black Box Warning

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. Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SPEVIGO. Hypersensitivity and Infusion-Related Reactions: Hypersensitivity including drug reaction with eosinophilia and systemic symptoms (DRESS) and infusion-related reactions may occur. If a serious hypersensitivity reaction occurs, discontinue SPEVIGO immediately and initiate appropriate treatment. Vaccinations: Do not administer live vaccines concurrently with SPEVIGO.

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

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. Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SPEVIGO. Hypersensitivity and Infusion-Related Reactions: Hypersensitivity including drug reaction with eosinophilia and systemic symptoms (DRESS) and infusion-related reactions may occur. If a serious hypersensitivity reaction occurs, discontinue SPEVIGO immediately and initiate appropriate treatment. Vaccinations: Do not administer live vaccines concurrently with SPEVIGO.

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.