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Elelyso

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Elelyso

INDICATIONS

ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease.

DOSAGE AND ADMINISTRATION

Recommended Dose

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 100mL 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.

  1. 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):
    1. Total dose in Units = Patient's weight (kg) x 60 Units/kg
    2. Total number of vials = Total dose in Units divided by 200 Units/vial
    3. Round up to the next whole vial.
  2. 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.
  3. 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.
  4. 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 preservatives, once reconstituted the product should be used immediately. If immediate use is not possible, the reconstituted vial may be stored for up to 24 hours at 2 to 8°C (36 to 46°F) under protection from light or for up to 12 hours at 20 to 25°C (68 to 77°F) without protection from light. The diluted product can be stored for up to 24 hours at 2 to 8°C (36 to 46°F) under protection from light. In total, the reconstituted product and the diluted product can be stored no more than 24 hours. Do not freeze. Discard any unused product.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: lyophilized powder for reconstitution; 200 Units/vial.

Storage And Handling

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. Revised: May 2014

Last reviewed on RxList: 5/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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