Dosing and Administration

SYLVANT® (siltuximab) Dosing and Administration

SYLVANT® dosing and administration

SYLVANT® (siltuximab) dosing and administration

SYLVANT® is given over 1 hour by infusion1 1 Hour every 3 Weeks

  • Recommended dosing: 11 mg/kg administered over 1 hour by intravenous (IV) infusion, every 3 weeks until treatment failure
  • Use aseptic technique for reconstitution and preparation of dosing solution
  • Once reconstituted, SYLVANT® should not be kept for more than 2 hours prior to adding to the infusion bag
  • The infusion should be completed within 4 hours of the dilution of the reconstituted solution to the infusion bag
  • Please click here to see the accompanying full Prescribing Information for complete dosing and administration, including preparation
SYLVANT® (siltuximab) Dosing and Administration

Preadministration laboratory tests1

  • 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. Do not reduce dose
Laboratory  parameter Requirement 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
Hemoglobin* <17 g/dL <17 g/dL

*SYLVANT® may increase hemoglobin levels in MCD patients.

SYLVANT® (siltuximab) Dosing and Administration

Anaphylaxis and infusion-related reactions1

  • Approximately 750 patients have been treated with SYLVANT®. Of these, one patient experienced an anaphylactic reaction
  • In an evaluation of patients exposed to SYLVANT® (N=249), infusion-related reactions were reported in 4.8% of patients

Infusion-Related Reactions and Hypersensitivity

  • Stop the infusion if the patient develops signs of anaphylaxis. Discontinue further therapy.
  • Stop the infusion if the patient develops mild to moderate infusion reactions. If the reaction resolves, the 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. The most common adverse reactions (>20%) reported by subjects receiving SYLVANT® in this study were upper respiratory tract infection, diarrhea, pain in extremities, arthralgia, and fatigue.
  • Administer SYLVANT® in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.

References

  1. SYLVANT® [package insert]. Horsham, PA: Janssen Biotech, Inc.