Dosing and Administration
SYLVANT® 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
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.
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.
- SYLVANT® [package insert]. Horsham, PA: Janssen Biotech, Inc.