Idiopathic multicentric Castleman disease (iMCD)

SYLVANT® (siltuximab) is the only therapy recommended as preferred by the NCCN® for the treatment of iMCD

Abbreviation: NCCN, National Comprehensive Cancer Network®.
Reference: Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed August 15, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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A nurse and two doctors are prepared to help diagnose and treat symptoms of iMCD.

Idiopathic multicentric Castleman disease (iMCD)

SYLVANT® (siltuximab): A proven anti-IL-6 therapy for your patients with iMCDa

SYLVANT® (siltuximab) is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Limitations 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.

Reference: SYLVANT [package insert]. Hertfordshire, UK: EUSA Pharma (UK) Ltd; 2019.

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Doctor feels the neck of a patient exhibiting iMCD symptoms.

iMCD can mimic autoimmune, malignant, and infectious disorders.1 SYLVANT works by binding directly to interleukin-6 (IL-6) and neutralizing it, which helps treat the symptoms associated with iMCD.2

  • A targeted therapy

    SYLVANT is the only therapy that targets and neutralizes IL-6 to help treat the symptoms of iMCD.2,3

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  • Dosing, administration, and home infusions

    SYLVANT is an intravenous infusion that is administered once every 3 weeks.2 EUSA Pharma also offers the option of home infusion to help prevent the disruption of treatment.

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    A nurse with a mask and gloves prepares an IV for Sylvant infusion.

  • Proven clinical results that help you fight iMCD

    The SYLVANT study was the largest one of its kind in iMCD. The safety and efficacy of SYLVANT have been studied for more than 7 years. That's why it's the guideline-preferred treatment for iMCD.4-6

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    A nurse and two doctors are prepared to help diagnose and treat symptoms of iMCD.

  • Get in touch with a rep

    Our representatives can provide you with helpful information, answer questions about dosing and administration, and assist you with ordering SYLVANT.

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    A Sylvant rep discusses Sylvant treatment options with a doctor.

References: 1. Fajgenbaum DC, Uldrick TS, Bagg A, et al. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood. 2017;129(12):1646-1657. 2. SYLVANT [package insert]. Hertfordshire, UK: EUSA Pharma (UK) Ltd; 2019. 3. Mukherjee S, Martin R, Sande B, Paige JS, Fajgenbaum DC. Epidemiology and treatment patterns of idiopathic multicentric Castleman disease in the era of IL-6 directed therapy. Blood Adv. 2022;6(2):359-367. 4. van Rhee F, Wong RS, Munshi N, et al. Siltuximab for multicentric Castleman's disease: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2014;15(9):966-974. 5. van Rhee F, Casper C, Voorhees PM, et al. Long-term safety of siltuximab in patients with idiopathic multicentric Castleman disease: a prespecified, open-label, extension analysis of two trials. Lancet Haematol. 2020;7(3):e209-e217. 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed August 15, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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Important Safety Information

What is SYLVANT?

SYLVANT® (siltuximab) is a prescription medicine used to treat people with multicentric Castleman’s disease (MCD) who do not have human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8) infection. It is not known if SYLVANT is safe and effective in children.

Important Safety Information

Indications and Usage

SYLVANT® (siltuximab) is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Limitations 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.

Contraindications

Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

Warnings and Precautions

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 medicating 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 (GI) Perforation

Gastrointestinal (GI) 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

The most common adverse reactions (<10% compared to placebo) in the MCD clinical trial were pruritus, increased weight, rash, hyperuricemia, and upper respiratory tract infections.

Drug Interactions

Cytochrome P450 Substrates

Upon initiation or discontinuation of SYLVANT, in patients being treated with CYP450 substrates with a narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. The effect of SYLVANT on CYP450 enzyme activity can persist for several weeks after stopping therapy. Exercise caution when SYLVANT is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin).

Dosage and Administration

Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

Do not administer SYLVANT to patients with severe infections until the infection resolves.

Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.

Please see full Prescribing Information for additional important safety information.