Siltuximab
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Siltuximab is a monoclonal antibody that is FDA approved for the treatment of patients with multi centric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Limitation of Use
SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. Common adverse reactions include pruritus, increased weight, rash, hyperuricemia, and upper respiratory tract infection.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Siltuximab FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Siltuximab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Siltuximab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Siltuximab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Siltuximab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Siltuximab in pediatric patients.
Contraindications
- Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.
Warnings
Concurrent Active Severe Infections
- Do not administer SYLVANT to patients with severe infections until the infection resolves. SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute phase reactants such as C-reactive protein (CRP). Monitor patients receiving SYLVANT closely for infections. Institute prompt anti-infective therapy and do not administer further SYLVANT until the infection resolves.
Vaccinations
- Do not administer live vaccines to patients receiving SYLVANT because IL-6 inhibition may interfere with the normal immune response to new antigens.
Infusion Related Reactions and Hypersensitivity
- Stop the infusion of SYLVANT if the patient develops signs of anaphylaxis. Discontinue further therapy with SYLVANT.
- Stop the infusion if the patient develops a mild to moderate infusion reaction. If the reaction resolves, the SYLVANT infusion may be restarted at a lower infusion rate. Consider medication with antihistamines, acetaminophen, and corticosteroids. Discontinue SYLVANT if the patient does not tolerate the infusion following these interventions.
- Administer SYLVANT in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.
Gastrointestinal Perforation
- Gastrointestinal perforation has been reported in clinical trials although not in MCD trials. Use with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with symptoms that may be associated or suggestive of GI perforation.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Siltuximab Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Siltuximab Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Siltuximab Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Siltuximab in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Siltuximab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Siltuximab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Siltuximab in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Siltuximab in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Siltuximab in geriatric settings.
Gender
There is no FDA guidance on the use of Siltuximab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Siltuximab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Siltuximab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Siltuximab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Siltuximab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Siltuximab in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Siltuximab Administration in the drug label.
Monitoring
There is limited information regarding Siltuximab Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Siltuximab and IV administrations.
Overdosage
There is limited information regarding Siltuximab 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 Siltuximab Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Siltuximab Mechanism of Action in the drug label.
Structure
There is limited information regarding Siltuximab Structure in the drug label.
Pharmacodynamics
There is limited information regarding Siltuximab Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Siltuximab Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Siltuximab Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Siltuximab Clinical Studies in the drug label.
How Supplied
There is limited information regarding Siltuximab How Supplied in the drug label.
Storage
There is limited information regarding Siltuximab 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 Siltuximab Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Siltuximab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Siltuximab Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Siltuximab 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.