Alternate Name(s):
Sylvant
Classification:
Interleukin-6 Receptor Antagonist (Anti IL-6)
Original Date:
February 2025
Indications:
-
Adults with Multicentric Castleman’s disease (MCD) who are HIV and HHV-8 negative
Reconstitution and Stability:
| Vial Size | SWFI | Post-Reconstitution Concentration |
| 100 mg | 5.2 mL | 20 mg/mL |
| 400 mg | 20 mL | 20 mg/mL |
- Available as 100mg or 400mg vials
- Store vials under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Allow vial(s) to come to room temperature over approximately 30 minutes.
- Do not shake. Protect from light.
- A 21-gauge 1-½ inch needle is recommended for preparation.
- Reconstituted vials are only stable for 2 hours prior to dilution, at room temperature.
- Dilute dose in 5% dextrose in water to an exact volume of 250 mL.
- Once diluted in 5% dextrose in water, dose should be administered immediately. The infusion should be completed within 4 hours of the dilution of the reconstituted solution to the infusion bag.
- Gently invert the bag to mix the solution.
- Infusion must be administered at room temperature.
- Infusion bags (250 mL) must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE). Alternatively, PE bottles may be used.
Compatibility:
- Solution Compatible: D5W
- Additives/buretrol Compatible: No information
- Y-site Compatible: No information
- Incompatible: DO NOT infuse with any other medication or solution.
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | No |
| IM | No |
| IV direct | No |
| IV Intermittent Infusion |
YES – Administer via peripheral line over 1 hour. Infusion time: 60 minutes using administration sets lined with PE, containing a 0.2-micron inline polyethersulfone (PES) filter. |
| IV Continuous Infusion | No |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
NOTE: Hematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter.
The following criteria must be met prior to initiation of therapy:
| Lab Parameter | Requirements before first administration | Retreatment Criteria |
| Absolute Neutrophil Count | ≥ 1.0 × 109 /L | ≥ 1.0 × 109 /L |
| Platelet Count | ≥ 75 × 109 /L |
≥ 50 × 109 /L |
| Hemoglobin | < 170 g/L | < 170 g/L |
- 11 mg/kg once every 3 weeks until treatment failure
Potential hazards of parenteral administration:
- Dermatological: maculo-papular rash, pruritis
- Respiratory: upper-respiratory tract infection, nasopharyngitis
- Cardiovascular: edema
- Endocrine: weight gain, hyperuricemia, hypertriglyceridemia, hypercholesterolemia
- Hypersensitivity and/or infusion-related reactions can occur; medications for treatment of hypersensitivity reactions should be available for immediate use
Notes:
- Monitor lipids
- Complete hematology lab tests (ANC, PLT and Hgb), as well as ESR, CRP, ferritin, and total IgG, prior to each dose for first 12 months, then after every 3 dosing cycles
- Monitor kidney and hepatic function
References:
- Sylvant Product Monograph, EUSA Pharma (UK) Limited, January 2021