Taliglucerase Alfa (Elelyso)

Trade Name : ELELYSO

Pfizer Laboratories Div Pfizer Inc

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 200 U/5mL

TALIGLUCERASE ALFA Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC],Glucosylceramidase [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Taliglucerase Alfa (Elelyso) which is also known as ELELYSO and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 200 U/5mL per ml. Read more

Taliglucerase Alfa (Elelyso) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

ELELYSO is indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.
ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease ().

Recommended Dosage in Patients 4 Years and Older ()
Preparation and Administration (, )

For injection: 200 units, lyophilized powder in single-use vials for reconstitution.
For injection: 200 units, lyophilized powder in single-use vials for reconstitution ()

None.
None ()

Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with ELELYSO. In clinical trials, 2 of 72 (3%) patients treated with ELELYSO experienced signs and symptoms consistent with anaphylaxis. Signs and symptoms of these patients included urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions occurred during ELELYSO infusion.
In clinical trials with ELELYSO, 21 of 72 (29%) patients experienced hypersensitivity reactions, including anaphylaxis. Signs and symptoms of hypersensitivity reactions included pruritus, angioedema, flushing, erythema, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions have occurred up to 3 hours after the start of infusion .
Due to the potential for anaphylaxis, appropriate medical support should be readily available when ELELYSO is administered. Observe patients closely for an appropriate period of time after administration of ELELYSO, taking into account the time to onset of anaphylaxis seen in clinical trials. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. If anaphylaxis occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated.
Management of hypersensitivity reactions should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of antihistamines, antipyretics, and/or corticosteroids for mild reactions. Pretreatment with antihistamines and/or corticosteroids may prevent subsequent hypersensitivity reactions. Patients were not routinely premedicated prior to infusion of ELELYSO during clinical studies. If severe hypersensitivity reactions occur, immediately stop the infusion of ELELYSO and initiate appropriate treatment.
Consider the risks and benefits of re-administering ELELYSO in patients who have experienced a severe reaction associated with ELELYSO. Caution should be exercised upon rechallenge, and appropriate medical support should be readily available n

Hypersensitivity Reactions Including Anaphylaxis:

The most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n

Treatment-Nau00efve Adults (u22655%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria ().
Patients Switched from Imiglucerase, after 9 Months on Treatment (u226510%): arthralgia, headache, pain in extremity ().

No data

Taliglucerase alfa, a hydrolytic lysosomal glucocerebroside-specific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme, u03b2-glucocerebrosidase, which is expressed in genetically modified carrot plant root cells cultured in a disposable bioreactor system (ProCellExu00ae). u03b2-Glucocerebrosidase (u03b2-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-u03b2-D-glucopyranoside (NP-Glc) per minute at 37u00b0C. After reconstitution with Sterile Water for Injection, taliglucerase alfa concentration is 40 units/mL . Reconstituted solutions have a pH of approximately 6.0.

No data

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with taliglucerase alfa. In a male and female fertility study in rats, taliglucerase alfa did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 55 mg/kg/day (about 5 times the recommended human dose of 60 units/kg based on the body surface area).

No data

ELELYSO is supplied as a lyophilized powder in single use vials. Each vial contains 200 units of ELELYSO.
NDC 0069-0106-01, 200 units per vial
Store ELELYSO under refrigeration at 2u00b0 C to 8u00b0 C (36u00b0 F to 46u00b0 F). Do not freeze. Protect vials from light.
As ELELYSO contains no preservative, the product should be used immediately once reconstituted. If immediate use is not possible, the reconstituted product may be stored for up to 24 hours at 2 to 8 u00b0C (36 to 46 u00b0F) under protection from light or up to 4 hours at 20 to 25 u00b0C (68 to 77 u00b0F) without protection from light. The diluted product may be stored for up to 24 hours at 2 to 8 u00b0C (36 to 46 u00b0F) under protection from light. Storage of the reconstituted product and the diluted product should not exceed a total of 24 hours. Do not freeze. Discard any unused product.

Hypersensitivity Reactions Including Anaphylaxis
Advise patients and caregivers that reactions related to administration and infusion may occur during and after ELELYSO treatment, including life-threatening anaphylaxis and severe hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis and hypersensitivity reactions, and have them seek medical care should signs and symptoms occur. Inform patients that they should be carefully re-evaluated for treatment with ELELYSO if serious hypersensitivity reactions, including anaphylaxis, occur. Reduction of the infusion rate and/or pre-treatment with antihistamines, antipyretics and/or corticosteroids may prevent subsequent reactions .

Licensed from Protalix Biotherapeutics
LAB-0610-8.0

NDC 0069-0106-01
Pfizer
Elelyson (taliglucerase alfa) for injection
200 units/vial
For intravenous infusion only
Single-use vial. Discard any unused portion. n n

NDC 0069-0106-01
Pfizer
Elelyson (taliglucerase alfa) for injection
200 units/vial
For intravenous infusion only
NGLPlacement
Single-use vial. Discard any unused portion. n n

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Taliglucerase Alfa (Elelyso)

Trade Name : ELELYSO

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Taliglucerase Alfa (Elelyso)

Trade Name : ELELYSO

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?