Brand Name
Elelyso
Generic Name
Taliglucerase
View Brand Information FDA approval date: May 01, 2012
Classification: Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Form: Injection
What is Elelyso (Taliglucerase)?
ELELYSO is indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease .
Approved To Treat
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Brand Information
ELELYSO (Taliglucerase alfa)
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
Patients treated with enzyme replacement therapies have experienced life‑threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ELELYSO and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life‑threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur Warnings and Precautions (5.1)].
1INDICATIONS AND USAGE
ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.
2DOSAGE FORMS AND STRENGTHS
For injection: 200 units white to off-white lyophilized powder in a single-dose vial for reconstitution.
3CONTRAINDICATIONS
None.
4DESCRIPTION
Taliglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme produced by recombinant DNA technology using plant cell culture (carrot). Taliglucerase alfa is a monomeric glycoprotein enzyme containing 4 N-linked glycosylation sites (kDa=60.8). 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.
A unit is the amount of enzyme that catalyzes the hydrolysis of 1 micromole of the synthetic substrate para-nitrophenyl-β-D-glucopyranoside (
ELELYSO (taliglucerase alfa) for injection is supplied as a sterile, preservative-free, lyophilized powder for reconstitution and dilution prior to intravenous infusion. Each single-dose vial contains 200 units of taliglucerase alfa and D-mannitol (206.7 mg), polysorbate 80 (0.56 mg), and sodium citrate (30.4 mg). Citric acid may be added to adjust the pH at the time of manufacture. After reconstitution with 5.1 mL Sterile Water for Injection, USP, taliglucerase alfa concentration is 40 units/mL
5HOW SUPPLIED/STORAGE AND HANDLING
ELELYSO (taliglucerase alfa) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial. Each vial of ELELYSO contains 200 units of taliglucerase alfa.
Each carton contains one vial (NDC 0069-0106-01).
6PRINCIPAL DISPLAY PANEL - 200 unit Vial Label
NDC 0069-0106-01
Pfizer
Elelyso
(taliglucerase alfa)
for injection
(taliglucerase alfa)
for injection
200 units/vial
For intravenous infusion only
Single-Dose Vial. Discard
7PRINCIPAL DISPLAY PANEL - 200 unit Vial Carton
NDC 0069-0106-01
Pfizer
Elelyso
(taliglucerase alfa)
for injection
(taliglucerase alfa)
for injection
200 units/vial
For intravenous infusion only
ANTI- COUNTERFEIT
Single-Dose Vial. Discard any
