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Dosing

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 testing, infusion preparation, and more.

  • Dosing
  • Preadministration
  • Preparation
  • Administration
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Dosing
1 hour every
3 weeks

11 mg/kg administered over 1 hour by intravenous infusion, every 3 weeks until treatment failure

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Preadministration

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 parameter Requirements before first SYLVANT administration Re-treatment criteria
Absolute neutrophil count ≥1.0 x 109/L ≥1.0 x 109/L
Platelet count ≥75 x 109/L ≥50 x 109/L
Hemoglobina <17 g/dL <17 g/dL
  1. SYLVANT may increase hemoglobin levels in patients with MCD.
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Administration

Preparing for an Infusion1

  • Strength 100-mg vial 400-mg vial
    Amount of Sterile Water for Injection, USP required for reconstitution 5.2 mL 20 mL
    Post-reconstitution concentration 20 mg/mL 20 mg/mL
  • 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 to the right
  • 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
prompt
  • 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.

Your Patients May Be Eligible for Home Infusions

icon home infusions

At EUSA Pharma, your patient’s health is our priority. That is why we are expanding access to our treatments through the new home infusion program. Home infusion is not meant to replace patients receiving treatment at a hospital, clinic, or infusion center; however, home infusion is an option that may prevent a disruption in the treatment plan.

Patients who choose to receive a home infusion must receive their first SYLVANT infusion at a clinic or hospital before transitioning to home infusion.

To start the enrollment process, or for additional information, please contact your EUSA Pharma representative or a Coram® CVS Specialty® Infusion Services representative.

Phone: 866-899-1661
Fax: 866-843-3221

Disclaimer: Insurance coverage of home infusion treatments vary by patients’ provider and plan. SYLVANT® (siltuximab) treatment must be initiated in an office or clinic setting before transitioning to home infusion.

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

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