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DOSAGE AND ADMINISTRATION
The recommended dose is 60 Units/kg of body weight administered once every 2 weeks as a 60-120 minute intravenous infusion.
Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to ELELYSO. Patients previously treated on a stable dose of imiglucerase are recommended to begin treatment with ELELYSO at that same dose when they switch from imiglucerase to ELELYSO.
Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals. Clinical studies have evaluated dose ranges from 11 Units/kg to 73 Units/kg every other week.
ELELYSO should be reconstituted with Sterile Water for Injection and diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of lOOmL to 200 mL, and delivered by intravenous infusion. The initial infusion rate should be 1.3 mL/min. After patient tolerability to the infusion rate is established, the rate of infusion may be increased to 2.3 mL/min. The total volume of the infusion solution should be delivered over a period of no less than 1 hour.
Each vial of ELELYSO provides 200 Units of taliglucerase alfa and is intended for single use only. Do not use the vial more than one time. The reconstitution and dilution steps must be completed using aseptic techniques. ELELYSO should be prepared using low-protein-binding containers and administered with a low-protein-binding infusion set equipped with an in-line, low-protein-binding 0.2 micrometer filter.
Instructions for Use
ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.
Prepare and use ELELYSO according to the following steps. Use aseptic technique.
- Determine the number of vials to be reconstituted based on the patient's weight and the recommended dose of 60 Units/kg, using the following calculations (1-3):
- Total dose in Units = Patient's weight (kg) x 60 Units/kg
- Total number of vials = Total dose in Units divided by 200 Units/vial
- Round up to the next whole vial.
- Remove the required number of vials from the refrigerator. Do not leave these vials at room temperature longer than 24 hours prior to reconstitution. Do not heat or microwave these vials.
- Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for Injection to yield a reconstituted product volume of 5.3 mL and a withdrawal volume of 5 mL. Upon reconstitution, mix vials gently. DO NOT SHAKE. Prior to further dilution, visually inspect the solution in the vials; the solution should be clear and colorless. Do not use if the solution is discolored or if foreign particulate matter is present.
- Withdraw 5 mL of reconstituted solution from each vial and dilute with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 — 200 mL. Mix gently. DO NOT SHAKE. Since this is a protein solution, slight flocculation (described as translucent fibers) occurs occasionally after dilution.
As ELELYSO contains no preservative, the product should be used immediately once reconstituted. If immediate use is not possible, the reconstituted or the diluted product may be stored for up to 24 hours at 2 to 8°C (36 to 46°F). Do not freeze. Protect from light. Discard any unused product.
Dosage Forms and Strengths
For injection: lyophilized powder for reconstitution; 200 Units/vial.
ELELYSO™ is available as a lyophilized powder, 200 Units per vial (NDC 0069 0106 01).
Store ELELYSO at 2 to 8°C (36 to 46°F). Protect vials from light.
Manufactured and distributed by: Pfizer Labs Division of Pfizer Inc. New York, NY 10017. Licensed from Protalix Biotherapeutics. Revised: May 2012
Last reviewed on RxList: 5/14/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Elelyso Information
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