Administered for

1 hour every 3 weeks
An iMCD patient in a white hoodie is ready to fight back with Sylvant.
Not actual patient

SYLVANT® (siltuximab) dosing and administration1

SYLVANT is administered by intravenous infusion once every 3 weeks until treatment failure. Preadministration tests are conducted before the treatment. See below or download the detailed Dosing and Administration Guide for specific information related to tests, infusion preparation, and more.

DOWNLOAD

Laboratory tests ensure effective use of SYLVANT1

Hematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If the treatment criteria in the table below are not met, consider delaying treatment until values improve. Do not reduce the dose.

It is not safe to administer SYLVANT to patients with severe infections.

Laboratory tests Sylvant

aSYLVANT may increase hemoglobin levels in patients with multicentric Castleman disease.

11 mg/kg administered by intravenousinfusion until treatment failure

Preparing for an infusion1

Preparing for an infusion Sylvant

  • Calculate the dose (mg) and total volume (mL) of reconstituted SYLVANT solution required and the number of vials needed.

  • Allow the vial(s) of SYLVANT to come to room temperature over approximately 30 minutes. SYLVANT should remain at room temperature for the duration of the preparation.

  • Aseptically reconstitute each SYLVANT vial as instructed in the table above.

  • Once reconstituted, and prior to further dilution, inspect the vials for particulates and discoloration. Do not use if particles or solution discoloration are present or if visibly opaque. The reconstituted product should be kept for no more than 2 hours prior to addition into the infusion bag.

  • Dilute the reconstituted SYLVANT solution dose in the infusion bag. Administer SYLVANT over 1 hour by infusion.

Exclamation Point Sylvant

  • DO NOT SHAKE or SWIRL VIGOROUSLY

  • GENTLY swirl the reconstituted vials to aid the dissolution of the lyophilized powder

  • Do not remove the contents until all of the solids have been completely dissolved

  • The lyophilized powder should dissolve in less than 60 minutes

  • Do not mix with saline

Quick Response Guide

Get SYLVANT storage, supply and aseptic technique; includes a sample weight-based dosing calculator.

DOWNLOAD
See More

SYLVANT® (siltuximab) for injection

INDICATIONS AND USAGE

SYLVANT® (siltuximab) is an interleukin-6 (IL-6) antagonist 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.

IMPORTANT SAFETY INFORMATION

SYLVANT is contraindicated in patients experiencing a severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

SYLVANT® (siltuximab) for injection

INDICATIONS AND USAGE

SYLVANT® (siltuximab) is an interleukin-6 (IL-6) antagonist 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.

IMPORTANT SAFETY INFORMATION

SYLVANT is contraindicated in patients experiencing a severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

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.

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

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).

Pregnancy and Lactation: SYLVANT may cause embryo-fetal harm when administered to pregnant women. Advise female patients of reproductive potential to use effective contraception during treatment with SYLVANT and for 3 months after the last dose. Advise females not to breastfeed during treatment with SYLVANT and for 3 months after the final dose.

Dosing 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.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases, Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before prescribing SYLVANT, please read the full Prescribing Information.

For your idiopathic multicentric Castleman disease (iMCD) Patients Taking SYLVANT® (siltuximab)

R.A.R.E.® can help

  • Co-pay assistance
  • Benefit investigations
  • Prior Authorization and Appeals Support:
    Phone: 1-855-299-8844
    Fax: 1-888-223-1746

One on one support

Helga will call enrolled patients to help:

  • Educate and answer questions about iMCD and SYLVANT
  • Help with access to SYLVANT medication
  • Connect them with other iMCD educational resources
LEARN MORE