"The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
Gaucher disease occurs in people who do not produce e"...
Limitation 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.
DOSAGE AND ADMINISTRATION
SYLVANT 11 mg/kg is given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
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 Table 1 are not met, consider delaying treatment with SYLVANT. Do not reduce dose.
Table 1: Treatment Criteria
|Laboratory parameter||Requirements before first SYLVANT administration||Retreatment 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|
|a SYLVANT may increase hemoglobin levels in MCD patients|
Do not administer SYLVANT to patients with severe infections until the infection resolves.
Instructions For Preparation And Administration
Use aseptic technique for reconstitution and preparation of dosing solution.
1. Calculate the dose (mg), total volume (mL) of reconstituted SYLVANT solution required and the number of vials needed. A 21-gauge 1. inch needle is recommended for preparation. Infusion bags (250 mL) must contain Dextrose 5% in Water and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE). Alternatively PE bottles may be used.
2. 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.
3. Aseptically reconstitute each SYLVANT vial as instructed in Table 2.
Table 2: Reconstitution Instructions
|Strength||Amount of Sterile Water for Injection, USP required for reconstitution||Post-reconstitution concentration|
|100 mg vial||5.2 mL||20 mg/mL|
|400 mg vial||20 mL||20 mg/mL|
Gently swirl the reconstituted vials to aid the dissolution of the lyophilized powder. DO NOT SHAKE or SWIRL VIGOROUSLY. Do not remove the contents until all of the solids have been completely dissolved. The lyophilized powder should dissolve in less than 60 minutes.
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 two hours prior to addition into the infusion bag.
4. Dilute the reconstituted SYLVANT solution dose to 250 mL with sterile Dextrose 5% in Water by withdrawing a volume equal to the total calculated volume of reconstituted SYLVANT from the Dextrose 5% in Water, 250 mL bag. Slowly add the total calculated volume (mL) of reconstituted SYLVANT solution to the Dextrose 5% in Water infusion bag. Gently invert the bag to mix the solution.
5. Administer the diluted SYLVANT solution in 5% Dextrose in Water 250 mL by intravenous infusion over a period of 1 hour using administration sets lined with PVC, or polyurethane (PU), or PE, containing a 0.2-micron inline polyethersulfone (PES) filter. The infusion should be completed within 4 hours of the dilution of the reconstituted solution to the infusion bag.
6. Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.
7. Do not store any unused portion of the reconstituted product or of the infusion solution. Waste material should be disposed of in accordance with local requirements.
Dosage Forms And Strengths
SYLVANT (siltuximab) for Injection is available as:
100 mg of lyophilized powder in a single-use vial for intravenous infusion.
400 mg of lyophilized powder in a single-use vial for intravenous infusion.
Storage And Handling
Each SYLVANT vial is individually packaged in a carton:
NDC 57894-420-01 contains one 100 mg vial, single use
NDC 57894-421-01 contains one 400 mg vial, single use vial
Storage And Stability
SYLVANT must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not use SYLVANT beyond the expiration date (EXP) located on the carton and the vial.
While stored, protect from light. This product contains no preservative.
Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, U.S. License No. 1864, At: Cilag AG, Schaffhausen, Switzerland, Product of the Netherlands. Revised: Jun 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/22/2016
Additional Sylvant Information
Report Problems to the Food and Drug Administration
Find out what women really need.