Elelyso Injection

Generic name: taliglucerase alfa
Dosage form: injection, powder, lyophilized, for solution
Drug class:Lysosomal enzymes

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

Indications and Usage for Elelyso Injection

ELELYSO is indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.

Elelyso Injection Dosage and Administration

Recommended Dosage in Patients 4 Years and Older

Treatment-naïve patients: The recommended dosage of ELELYSO for long-term treatment is 60 units/kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.

Patients switching from imiglucerase: Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to ELELYSO. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same units/kg dosage when they switch from imiglucerase to ELELYSO. Administer ELELYSO for long-term treatment every other week as a 60 to 120 minute intravenous infusion. Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals [see Clinical Studies (14.2)].

Preparation Instructions

ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.

Each vial of ELELYSO provides 200 units of taliglucerase alfa and is intended for one-time use and for only one patient. The reconstitution and dilution steps must be completed using aseptic technique.

ELELYSO should be reconstituted with Sterile Water for Injection, USP and diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 mL to 200 mL, and administered by intravenous infusion.

Prepare 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 = ..