Elelyso
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Uses
ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with a confirmed diagnosis of Type 1 Gaucher disease.
History
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Other Information
Taliglucerase alfa, a hydrolytic lysosomal glucocerebroside-specific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme, β-glucocerebrosidase, which is expressed in genetically modified carrot plant root cells cultured in a disposable bioreactor system (ProCellEx®). β-Glucocerebrosidase (β-D-glucosyl-N-acylsphingosine glucohydrolase, E.C. 3.2.1.45) is a lysosomal glycoprotein enzyme that catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and ceramide.
ELELYSO is produced by recombinant DNA technology using plant cell culture (carrot). Purified taliglucerase alfa is a monomeric glycoprotein containing 4 N-linked glycosylation sites (Mr = 60,800). Taliglucerase alfa differs from native human glucocerebrosidase by two amino acids at the N terminal and up to 7 amino acids at the C terminal. Taliglucerase alfa is a glycosylated protein with oligosaccharide chains at the glycosylation sites having terminal mannose sugars. These mannose-terminated oligosaccharide chains of taliglucerase alfa are specifically recognized by endocytic carbohydrate receptors on macrophages, the cells that accumulate lipid in Gaucher disease.
ELELYSO is supplied as a sterile, non-pyrogenic, lyophilized product. The quantitative composition of each 200 Unit vial is D-mannitol (206.7 mg), polysorbate 80 (0.56 mg), sodium citrate (30.4 mg), and taliglucerase alfa (212 Units). Citric acid may be added to adjust the pH at the time of manufacture.
A Unit is the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (pNP-Glc) per minute at 37°C. After reconstitution with Sterile Water for Injection the taliglucerase alfa concentration is 40 Units/mL [see Dosage and Administration ( 2)]. Reconstituted solutions have a pH of approximately 6.0.
Sources
Elelyso Manufacturers
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Pfizer Laboratories Div Pfizer Inc
![Elelyso (Taliglucerase Alfa) Injection, Powder, Lyophilized, For Solution [Pfizer Laboratories Div Pfizer Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Elelyso | Pfizer Laboratories Div Pfizer Inc
2.1 Recommended DoseThe 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 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 100 mL 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.
2.2 Instructions for UseELELYSO 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.
a. 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. b. 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. c. 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 particular matter is present. d. 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.
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