Dailymed elelyso taliglucerase alfa injection, powder. Openlabel, expanded access study of taliglucerase alfa in. Taliglucerase alfa, commercially known as elelyso, is a biopharmaceutical drug developed by protalix and pfizer. Taliglucerase alfa is an enzyme replacement therapy approved for treatment of gaucher. Taliglucerase alfa bluecross blueshield of tennessee. Taliglucerase alfa, the first available plant cell expressed recombinant therapeutic protein, is an. Taliglucerase alfa protalix biotherapeutics, carmiel, israel is a carrot cellexpressed human recombinant.
Elelyso taliglucerase alfa for injection is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease. Elelyso taliglucerase alfa rpc drug medicine information. Download the pdf icon dosage and administration guide. However, if the volume of the reconstituted product. Taliglucerase alfa is a unique product, as it is the first plant cellbased recombinant enzyme therapy. Get emergency medical help if you have signs of an allergic reaction. Taliglucerase alfa for injection elelyso, a hydrolytic lysosomal glucocerebrosidespecific enzyme, was approved by the u. Longterm safety and efficacy of taliglucerase alfa in pediatric.
Taliglucerase alfa is the first us food and drug administrationapproved plant cellexpressed recombinant human protein, using carrot root cell. Notably, taliglucerase alfa is the first recombinant therapeutic protein totally produced in a suspension of plant cells approved by the u. Elelyso taliglucerase alfa pfizer medical information. Taliglucerase alfa is an enzyme replacement therapy for treatment of gaucher disease gd. Elelyso taliglucerase alfa elelyso fep clinical rationale patients younger than 4 years of age 1. Description taliglucerase alfa rpc is a glycosylated protein with approximately 7% of its molecular mass contributed by glycans. You may be given other medications to prevent certain side effects of taliglucerase alfa. Some people receiving a taliglucerase alfa injection have had a reaction when the medicine was injected, or up to 3 hours later. The relatively few therapeutic options and high cost of ert represent an inherent problem for the treatment of patients with type 1 gaucher disease 9. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of elelyso while maintaining optimal therapeutic outcomes. The glycans present in taliglucerase alfa rpc are typical of plant. Please consult a qualified health professional for more detailed information. Elelyso taliglucerase alfa for injection physician order form phone 1855elelyso 18553535976 n fax 186675875 rd 501n please note.
Taliglucerase alfa was also approved by the israeli ministry of health in september 2012, by the brazilian ministry of health in march 20, and by the applicable regulatory authorities. Protalix announces nda submission update for taliglucerase alfa for the treatment of gaucher disease feb. Elelyso is supplied as a white to offwhite powder that may form a cake. Food and drug administration fda may 1, 2012 for longterm enzyme replacement therapy ert for adults with a confirmed diagnosis of type 1 gaucher disease. A healthcare provider will give you this injection. Longterm enzyme replacement therapy in patients with nonneuronopathic type 1 gaucher disease 1 5 9 designated an orphan drug by fda for this use. The medicine has been developed as an enzyme replacement therapy by p rotalix limited, and pfizer australia pl is the australian sponsor. Taliglucerase alfa is the first plant cellexpressed recombinant therapeutic protein approved for use in humans and is approved for the treatment of patients with communicating editor. Dosing elelyso taliglucerase alfa for injection safety info. After reconstitution the solution is a clear, colourless liquid. Taliglucerase is used as an enzyme replacement in people with type i gaucher disease in adults and children at least 4 years old. A pfizer spokesman said taliglucerase alfa will be available from centric health resources, a specialty pharmacy provider. Nov 09, 2018 taliglucerase alfa is injected into a vein through an iv.
Pivotal trial with plant cellexpressed recombinant. This is a category 1 submission to register elelyso taliglucerase alfa for the treatment of systemic symptoms in patients with gaucher disease. These patients have a genetic deficiency of the lysosomal enzyme glucocerebrosidase that leads to accumulation of glucosylceramide in the lysosomes of. Food and drug administration fda for use in both adults and children affected by the disease. A plantbased expression system, using carrot root cell cultures, was developed for production of taliglucerase alfa and does not require additional processing for postproduction glycosidic modifications. Full text spotlight on taliglucerase alfa in the treatment. Openlabel, expanded access study of taliglucerase alfa in patients with gaucher disease. Full text spotlight on taliglucerase alfa in the treatment of pediatric. Taliglucerase alfa, a hydrolytic lysosomal glucocerebrosidespecific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme. Jan 03, 2017 elelyso taliglucerase alfa for intravenous injection. Purified taliglucerase alfa is a monomeric glycoprotein containing 4 nlinked glycosylation sites mr 60,800. Spotlight on taliglucerase alfa in the treatment of pediatric.
Product monograph download pdf, 691kb patient information download pdf, 224kb. Injection, taliglucerase alfa, 10 units j3060 hcpcs codes. Taliglucerase alfa is a recombinant active form of the lysosomal enzyme. Taliglucerase alfa will be supplied in 200unit vials that should be refrigerated until use. It is derived from genetically modified carrot plant root cells. Taliglucerase alfa is an intravenous enzyme replacement therapy approved for treatment of type 1 gaucher disease gd, and is the first available plant cellexpressed recombinant therapeutic protein. Protalix announces nda submission update for taliglucerase. Elelyso is produced by recombinant dna technology using plant cell culture carrot. Taliglucerase alfa therapy safe for some children with gd. Oct 31, 2019 taliglucerase alfa, a hydrolytic lysosomal glucocerebrosidespecific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme. This disease is caused by the lack of a certain enzyme in the body called glucocerebrosidase. Download pdf elaprase idursulfase download pdf elelyso taliglucerase alfa download pdf eloxatin oxaliplatin download pdf elzonris.
Herein, we report longterm safety and efficacy results of taliglucerase alfa in treatmentnaive adult patients with gd. Elelyso should be reconstituted with sterile water for injection and diluted with 0. Tell your caregivers right away if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash. Eleven patients were randomized to receive taliglucerase alfa 30 ukg or 60 ukg per infusion every other week for 12 months and all 11 completed the study. Hcpcs code j3060 for injection, taliglucerase alfa, 10 units as maintained by cms falls under drugs, administered by injection. Nov 24, 2011 taliglucerase alfa protalix biotherapeutics, carmiel, israel is a carrot cellexpressed human recombinant. Elelyso taliglucerase alfa rpc 200 units powder for injection taliglucerase alfa recombinant plant carrot rpc.
Elelyso taliglucerase alfa clinical studies pfizer. Taliglucerase alfa drug monograph pediatric care online. Elelyso for gaucher disease protalix biotherapeutics. Taliglucerase alfa is an enzyme replacement therapy ert approved for treatment of adult and paediatric patients with type 1 gaucher disease gd in several countries and the first plant cellexpressed recombinant therapeutic protein approved by the us food and drug administration for humans. Each vial of elelyso taliglucerase alfa for injection provides 200 units of taliglucerase alfa and is intended for single use only. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase gcd is the companys first approved drug product developed using procellex.
Download pdf eeg noninvasive electroencephalogram commercialmedicaid new. Taliglucerase alfa medicare coverage and copay details goodrx. Taliglucerase alfa is injected into a vein through an iv. To report an adverse event, please call 18004381985.
Elelyso taliglucerase alfa for injection is a hydrolytic lyso somal glucocerebrosidespecific enzyme indicated for longterm enzyme replacement therapy ert for adults with a confirmed diagnosis of type 1 gaucher disease. The fda has approved taliglucerase alfa ta lee gloo. Elelyso taliglucerase alfa for injection is a hydrolytic lysosomal glucocerebrosidespecific enzyme indicated for longterm enzyme replacement therapy ert for adults with a confirmed diagnosis of type 1 gaucher disease. Taliglucerase alfa definition of taliglucerase alfa by. Pdf taliglucerase alfa is an enzyme replacement therapy ert approved for treatment of adult and paediatric. Taliglucerase alfa side effects, dosage, interactions. Elelyso taliglucerase alfa for injection is a hydrolytic lysosomal glucocerebrosidespecific enzyme indicated for longterm enzyme replacement therapy. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Quick reference guide for elelyso taliglucerase alfa for. This leaflet is part iii of a threepart product monograph published when elelyso was approved for sale in canada. Download pdf eeg ambulatory monitoring electroencephalogram new. Longterm efficacy and safety results of taliglucerase alfa. The reconstituted solution must be further diluted for.
Overall, the mean yearly dose of taliglucerase alfa from 2010 to 2014 remained stable over time, and was similar to mean imiglucerase doses prior to the shortage 43 ukginfusion during imiglucerase vs 40. If immediate use after reconstitution or dilution is not possible, the drug solution can be stored at 48 c for up to 24 hours. It is used to treat the symptoms of gauchers disease. Taliglucerase alfa approved for gaucher disease american. Elelyso taliglucerase alfa pfizer medical information us. Taliglucerase alfa is an ert approved for the treatment of adult patients with type 1 gd in the united. Taliglucerase alfa injection is used for the longterm treatment of type 1 gaucher disease. Nov 22, 2016 taliglucerase alfa is an enzyme replacement therapy for treatment of gaucher disease gd. Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials lipids. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. The safety and efficacy of elelyso were assessed in 31 patients 26 adult and 5 pediatric patients with type 1 gaucher disease who were switched from imiglucerase to elelyso. Safety and efficacy across 6 clinical studies in adults and children with gaucher disease article pdf available in orphanet journal of rare diseases 1 december 2018. Benefit determinations are subject to applicable member contract languag.
Taliglucerase alfa is a manmade form of an enzyme that is missing in patients with gauchers disease. Longterm efficacy and safety results of taliglucerase alfa through 5. Feb 02, 2010 protalix announces nda submission update for taliglucerase alfa for the treatment of gaucher disease feb. Elelyso taliglucerase alfa for injection product monograph page 5 of 27 infusion rate, treating with medicinal products such as antihistamines, antipyretics andor corticosteroids, andor stopping and resuming treatment with decreased infusion rate. Product monograph download pdf, 691kb patient information download pdf, 224kb canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. Jun 15, 2012 taliglucerase alfa will be supplied in 200unit vials that should be refrigerated until use. Spotlight on taliglucerase alfa in the treatment of pediatric patients with type 1 gaucher disease punita gupta,1 gregory m pastores2 1division of genetics, department of pediatrics, st. The approval for taliglucerase alfa was based on data from the following clinical trials in patients with type 1 gaucher disease. Nov 07, 2019 taliglucerase is used as an enzyme replacement in people with type i gaucher disease in adults and children at least 4 years old. For adult patients, a final volume of to 150 ml may be used. Elelyso taliglucerase alfa description pfizer medical.
786 517 1237 1193 1328 1119 607 15 1303 1217 498 553 1277 671 542 992 1185 617 914 1086 1037 1093 186 198 1177 1285 438 1414 11 1196 984