This document plus the full product monograph, prepared for. Elelyso taliglucerase alfa for injection product monograph page. Taliglucerase alfa, a hydrolytic lysosomal glucocerebrosidespecific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme. Elelyso taliglucerase alfa clinical pharmacology pfizer. In patients with gaucher disease, taliglucerase alfa rpc is rapidly eliminated. Elelyso for gaucher disease protalix biotherapeutics. Below are the pfizer medicines available to eligible patients through two of these programs, the pfizer patient assistance program and the pfizer savings program. Taliglucerase alfa doses are based on weight especially in children and teenagers. Each vial of elelyso 200contains units of taliglucerase alfa rpc, 195 mg mannitol, 28. Elelyso taliglucerase alfa for injection is a hydrolytic lysosomal glucocerebroside specific enzyme indicated for longterm enzyme replacement therapy. Elelyso taliglucerase alfa is intended for enzyme replacement therapy ert of gaucher disease gd, which is a rare genetic disorder.
Benefit determinations are subject to applicable member contract language. Elelyso taliglucerase alfa elelyso fep clinical rationale patients younger than 4 years of age 1. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if. Elelyso taliglucerase alfa rpc 200 units powder for injection taliglucerase alfa recombinant plant carrot rpc. Patients received taliglucerase alfa every two weeks at a dose equivalent to their stable imiglucerase dose. Cerezyme imiglucerase, vpriv velaglucerase alfa, and eleyso taliglucerase alfa will be considered for coverage under the pharmacy benefit program when the following criteria are met. Requires prior authorization by medical director or designee. Please see ful important safet information on page 6 nd ful prescribin information startin on page 7. This disease is caused by the lack of a certain enzyme in the body called glucocerebrosidase. Any person who knowingly files a request for authorization of coverage of a medical procedure or service with the intent to. 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 intravenous route national library of.
Elelyso taliglucerase alfa for injection physician order form phone 1855elelyso 18553535976 n fax 186675875 rd 501n please note. Introduction17 taliglucerase alfa for injection elelyso, a hydrolytic lysosomal glucocerebrosidespecific enzyme, was approved by the u. And medical record documentation of a confirmed diagnosis of type 1 gaucher disease along with at least one of the following symptoms. Tell your caregivers right away if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash. Elelyso taliglucerase alfa pfizer medical information us. Taliglucerase alfa is a glycosylated protein with oligosaccharide chains at the glycosylation sites having terminal mannose sugars. Taliglucerase alfa replaces the missing enzyme to help the body. After a single dose by intravenous infusion over 1 to 2 hours at a. Elelyso is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with type 1 gaucher disease.
Jan 03, 2017 elelyso taliglucerase alfa for intravenous injection. 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. Pdf taliglucerase alfa is an enzyme replacement therapy ert approved for. Taliglucerase alfa elelyso j3060 m x x leuprolide acetate eligard j9217 m x x rasburicase elitek j2783 m x x epirubicin ellence j9178 m x x factor viii fc eloctate j7205 m x x x oxaliplatin eloxatin j9263 m x x asparaginase elspar j9020 m x x tagraxofusperzs elzonris j9269 m x x aprepitant emend capsule j8501 p x x. 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. Do not use elelyso if you are allergic to taliglucerase alfa or to any ingredient. 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. It is derived from genetically modified carrot plant root cells. Ask your doctor if you have any questions about why this medicine has. Fda approved indications elelyso is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease gd1.
Ontario guidelinesfortreatmentofgaucheraugust20112. May 01, 2012 elelyso taliglucerase alfa injection company. While patients and others may access this document, the document is made. Part b drugs is outlined in the medicare benefit policy manual.
The most common adverse reactions in patients taking elelyso taliglucerase alfa for injection are itching, flushing, headache, joint pain, pain in extremity, abdominal pain, vomiting, diarrhea, fatigue, back pain, dizziness, nausea, and rash. 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. Taliglucerase alfa injection is used for the longterm treatment of type 1 gaucher disease. Taliglucerase alfa rat oral ld 50 500 mgkg 39 weeks monkey no route specified27. Taliglucerase alfa, a proprietary plant cellexpressed recombinant form of glucosylceramidase, is being developed by protalix biotherapeutics, in collaboration. Velaglucerase alfa trade name vpriv, manufactured by shire plc is a hydrolytic lysosomal glucocerebrosidespecific enzyme, which is a recombinant form of glucocerebrosidase indicated as a longterm enzyme replacement therapy for those suffering of gaucher disease type 1. Elelyso should be prepared using lowproteinbinding containers and administered with a. 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. Elelyso is produced by recombinant dna technology using plant cell culture carrot. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred.
Elelyso should be reconstituted with sterile water for injection and diluted with 0. 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. To report an adverse event, please call 18004381985. Elelyso taliglucerase alfa dosage and administration pfizer. Follow your doctors dosing instructions very carefully. Pharmacokinetics of taliglucerase alfa were evaluated in 38 patients 29 adult and 9 pediatric patients who received intravenous infusions of elelyso 30. Qualitative and quantitative composition elelyso taliglucerase alfa rpc 200 units powder for injection. Elelyso taliglucerase alfa medication precertification request aetna precertification notification 503 sunport lane, orlando, fl 32809. Drug taliglucerase alfa elelyso 30 to 60 ukg intravenous infusion indication longterm enzyme replacement therapy for adults and children 2 to 17 years old with a confirmed diagnosis of type 1 gaucher disease and for hematological manifestations in pediatric patients with a confirmed diagnosis of type 3 gaucher disease. Get emergency medical help if you have signs of an allergic reaction. Cerezyme imiglucerase, vpriv velaglucerase alfa, elelyso. 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.
Patients currently receiving imiglucerase can be switched to taliglucerase alfa at the same dosage. Elelyso taliglucerase alfa for injection is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease. Adjust dosage based on achievement and maintenance of the patients therapeutic goals. Taliglucerase alfa 30 ukg and 60 ukg were efficacious in treatmentnaive adults in study pb06001 and in treatmentnaive pediatric patients in study pb06005. Elelyso, inntaliglucerase alfa european medicines agency. 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. Each vial of elelyso taliglucerase alfa for injection provides 200 units of taliglucerase alfa and is intended for single use only. For pediatric patients, a final volume of 100120 ml should be used. Taliglucerase alfa bluecross blueshield of tennessee. Australian public assessment report for taliglucerase alfa rpc. It has an identical amino acid sequence to the naturally occurring enzyme. Taliglucerase alfa is a recombinant active form of the lysosomal enzyme. For adult patients, a final volume of to 150 ml may be used.
Taliglucerase alfa is a manmade form of an enzyme that is missing in patients with gauchers disease. Each vial of elelyso contains 200 units of taliglucerase alfa rpc. It is used to treat the symptoms of gauchers disease. Your doctor may occasionally change your dose to make sure you get the best results. Benefit determinations are subject to applicable member contract languag. Taliglucerase alfa is usually given every other week. Elelyso, a long term enzyme replacement therapy, is a recombinant analog of human lysosomal. Vpriv should be administered under the supervision. Each vial of elelyso provides 200 units of taliglucerase alfa and is intended for single use only.
From thirtyfive 35 adult patients files initially screened, twentytwo were excluded from efficacy analysis 4 patients were on treatment with taliglucerase alfa but with periods of interruption of more than 3 months and 18 patients had the treatment permanently discontinued. The drug, a recombinant glucocerebrosidase used to treat gauchers disease, was the first plantmade pharmaceutical to win approval by the u. However, if the volume of the reconstituted product. The medicine has been developed as an enzyme replacement therapy by p rotalix limited, and pfizer australia pl is the australian sponsor. Elelyso taliglucerase alfa rpc drug medicine information. Some people receiving a taliglucerase alfa injection have had a reaction when the medicine was injected, or up to 3 hours later. Taliglucerase alfa, commercially known as elelyso, is a biopharmaceutical drug developed by protalix and pfizer. 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. January 1, 2020 page 2 of 3 moderate to severe hepatomegaly liver size 1. The application to register taliglucerase alfa was first submitted to the tga in may 2011 submission number pm20110047833.
This is a category 1 submission to register elelyso taliglucerase alfa for the treatment of systemic symptoms in patients with gaucher disease. Elelyso taliglucerase alfa is recommended by a metabolic specialist with experience in treating gaucher disease pediatric patients. Dailymed elelyso taliglucerase alfa injection, powder. Elelyso taliglucerase alfa for injection should be reconstituted, diluted, and administered under the supervision of a healthcare professional. The reconstitution and dilution steps must be completed using aseptic techniques. Taliglucerase alfa elelyso national drug monograph. Pretreatment with antihistamines andor corticosteroids may prevent subsequent reactions see. Please consult a qualified health professional for more detailed information. Vpriv should be administered under the supervision of a healthcare professional. Patients currently receiving imiglucerase can be switched to taliglucerase alfa at the same.
Description taliglucerase alfa rpc is a glycosylated protein with approximately 7% of its molecular mass contributed by glycans. Australian product information elelyso taliglucerase. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of elelyso while maintaining optimal therapeutic outcomes. Taliglucerase alfa medicare coverage and copay details. Taliglucerase alfa rpc is a white to offwhite lyophilised powder, that may form a cake. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Policycriteria provider must submit documentation such as office chart notes, lab results or other clinical. The glycans present in taliglucerase alfa rpc are typical of plant. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase gcd is the companys first approved drug product developed using procellex.
Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials lipids. Elelyso taliglucerase alfa medication precertification request. Purified taliglucerase alfa is a monomeric glycoprotein containing 4 nlinked glycosylation sites mr 60,800. Quick reference guide for elelyso taliglucerase alfa for. 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. Product monograph download pdf, 691kb patient information download pdf, 224kb. Elelyso taliglucerase alfa clinical studies pfizer. Elelyso taliglucerase alfa is a hydrolytic lysosomal glucocerebrosidespecific enzyme indicated for longterm enzyme replacement therapy ert for adults with a confirmed diagnosis of type 1 gaucher disease. These mannoseterminated oligosaccharide chains of taliglucerase alfa are specifically recognized by endocytic carbohydrate receptors on macrophages, the cells that accumulate lipid in gaucher disease. Oct 31, 2019 taliglucerase alfa is a glycosylated protein with oligosaccharide chains at the glycosylation sites having terminal mannose sugars. For 2016, elelyso was ranked third for pharmaceuticals with. Taliglucerase alfa was well tolerated, and meaningful and sustained. After reconstitution, the solution contains 40 units approximately 1.
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