Taliglucerase alfa rpc is a white to offwhite lyophilised powder, that may form a cake. 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. This disease is caused by the lack of a certain enzyme in the body called glucocerebrosidase. Purified taliglucerase alfa is a monomeric glycoprotein containing 4 nlinked glycosylation sites mr 60,800. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if. Qualitative and quantitative composition elelyso taliglucerase alfa rpc 200 units powder for injection. Policycriteria provider must submit documentation such as office chart notes, lab results or other clinical. Elelyso taliglucerase alfa for injection is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease. Elelyso should be prepared using lowproteinbinding containers and administered with a. The application to register taliglucerase alfa was first submitted to the tga in may 2011 submission number pm20110047833. The glycans present in taliglucerase alfa rpc are typical of plant.
This document plus the full product monograph, prepared for. Elelyso taliglucerase alfa is recommended by a metabolic specialist with experience in treating gaucher disease pediatric patients. Elelyso, inntaliglucerase alfa european medicines agency. Dailymed elelyso taliglucerase alfa injection, powder.
Benefit determinations are subject to applicable member contract language. Elelyso should be reconstituted with sterile water for injection and diluted with 0. Taliglucerase alfa is a recombinant active form of the lysosomal enzyme. However, if the volume of the reconstituted product. While patients and others may access this document, the document is made. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred. For 2016, elelyso was ranked third for pharmaceuticals with. Elelyso taliglucerase alfa for injection physician order form phone 1855elelyso 18553535976 n fax 186675875 rd 501n please note. Any person who knowingly files a request for authorization of coverage of a medical procedure or service with the intent to. Elelyso for gaucher disease protalix biotherapeutics. Please consult a qualified health professional for more detailed information.
Each vial of elelyso contains 200 units of taliglucerase alfa rpc. Part b drugs is outlined in the medicare benefit policy manual. Australian product information elelyso taliglucerase. It is used to treat the symptoms of gauchers disease. To report an adverse event, please call 18004381985. Get emergency medical help if you have signs of an allergic reaction. 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. Elelyso taliglucerase alfa is intended for enzyme replacement therapy ert of gaucher disease gd, which is a rare genetic disorder. Each vial of elelyso taliglucerase alfa for injection provides 200 units of taliglucerase alfa and is intended for single use only. Do not use elelyso if you are allergic to taliglucerase alfa or to any ingredient. Quick reference guide for elelyso taliglucerase alfa for. Follow your doctors dosing instructions very carefully. Elelyso taliglucerase alfa dosage and administration pfizer.
Elelyso taliglucerase alfa clinical pharmacology pfizer. Patients currently receiving imiglucerase can be switched to taliglucerase alfa at the same dosage. Ask your doctor if you have any questions about why this medicine has. Adjust dosage based on achievement and maintenance of the patients therapeutic goals. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. Pretreatment with antihistamines andor corticosteroids may prevent subsequent reactions see. Taliglucerase alfa was well tolerated, and meaningful and sustained. 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, commercially known as elelyso, is a biopharmaceutical drug developed by protalix and pfizer.
The drug, a recombinant glucocerebrosidase used to treat gauchers disease, was the first plantmade pharmaceutical to win approval by the u. Product monograph download pdf, 691kb patient information download pdf, 224kb. Please see ful important safet information on page 6 nd ful prescribin information startin on page 7. Taliglucerase alfa injection is used for the longterm treatment of type 1 gaucher disease. Below are the pfizer medicines available to eligible patients through two of these programs, the pfizer patient assistance program and the pfizer savings program. 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. These mannoseterminated oligosaccharide chains of taliglucerase alfa are specifically recognized by endocytic carbohydrate receptors on macrophages, the cells that accumulate lipid in gaucher disease. Elelyso taliglucerase alfa rpc 200 units powder for injection taliglucerase alfa recombinant plant carrot rpc. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. 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. 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. Taliglucerase alfa 30 ukg and 60 ukg were efficacious in treatmentnaive adults in study pb06001 and in treatmentnaive pediatric patients in study pb06005. 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.
In patients with gaucher disease, taliglucerase alfa rpc is rapidly eliminated. Taliglucerase alfa, a proprietary plant cellexpressed recombinant form of glucosylceramidase, is being developed by protalix biotherapeutics, in collaboration. Elelyso is produced by recombinant dna technology using plant cell culture carrot. Your dose needs may change if you gain or lose weight.
Ontario guidelinesfortreatmentofgaucheraugust20112. Cerezyme imiglucerase, vpriv velaglucerase alfa, elelyso. Elelyso taliglucerase alfa rpc drug medicine information. Pdf taliglucerase alfa is an enzyme replacement therapy ert approved for. Taliglucerase alfa replaces the missing enzyme to help the body. 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. 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. Patients received taliglucerase alfa every two weeks at a dose equivalent to their stable imiglucerase dose. Taliglucerase alfa is a glycosylated protein with oligosaccharide chains at the glycosylation sites having terminal mannose sugars. Elelyso taliglucerase alfa clinical studies pfizer. Vpriv should be administered under the supervision of a healthcare professional. Your doctor may occasionally change your dose to make sure you get the best results. Elelyso is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with type 1 gaucher disease. It is derived from genetically modified carrot plant root cells.
Oct 31, 2019 taliglucerase alfa is a glycosylated protein with oligosaccharide chains at the glycosylation sites having terminal mannose sugars. 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. 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. And medical record documentation of a confirmed diagnosis of type 1 gaucher disease along with at least one of the following symptoms. 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. Pharmacokinetics of taliglucerase alfa were evaluated in 38 patients 29 adult and 9 pediatric patients who received intravenous infusions of elelyso 30. Taliglucerase alfa intravenous route national library. Taliglucerase alfa intravenous route national library of. 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. Taliglucerase alfa elelyso national drug monograph. Taliglucerase alfa drug monograph pediatric care online. This is a category 1 submission to register elelyso taliglucerase alfa for the treatment of systemic symptoms in patients with gaucher disease. Benefit determinations are subject to applicable member contract languag. Elelyso taliglucerase alfa for injection should be reconstituted, diluted, and administered under the supervision of a healthcare professional.
Tell your caregivers right away if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash. Each vial of elelyso 200contains units of taliglucerase alfa rpc, 195 mg mannitol, 28. 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. Taliglucerase alfa, a hydrolytic lysosomal glucocerebrosidespecific enzyme for intravenous infusion, is a recombinant active form of the lysosomal enzyme. Elelyso taliglucerase alfa for injection is a hydrolytic lysosomal glucocerebroside specific enzyme indicated for longterm enzyme replacement therapy.
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. Taliglucerase alfa doses are based on weight especially in children and teenagers. The reconstitution and dilution steps must be completed using aseptic techniques. Elelyso, a long term enzyme replacement therapy, is a recombinant analog of human lysosomal. Australian public assessment report for taliglucerase alfa rpc.
Elelyso taliglucerase alfa pfizer medical information us. 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 medication precertification request aetna precertification notification 503 sunport lane, orlando, fl 32809. Requires prior authorization by medical director or designee. Patients currently receiving imiglucerase can be switched to taliglucerase alfa at the same. Elelyso taliglucerase alfa elelyso fep clinical rationale patients younger than 4 years of age 1. Study 004 n 59 was an openlabel study conducted to evaluate the safety of taliglucerase alfa in adult gd patients who were previously treated with imiglucerase. 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. Elelyso taliglucerase alfa for injection product monograph page.
Taliglucerase alfa is a manmade form of an enzyme that is missing in patients with gauchers disease. Description taliglucerase alfa rpc is a glycosylated protein with approximately 7% of its molecular mass contributed by glycans. For adult patients, a final volume of to 150 ml may be used. Fda approved indications elelyso is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease gd1. Some people receiving a taliglucerase alfa injection have had a reaction when the medicine was injected, or up to 3 hours later. 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. After reconstitution, the solution contains 40 units approximately 1. It has an identical amino acid sequence to the naturally occurring enzyme. 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. 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.
Elelyso taliglucerase alfa medication precertification request. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of elelyso while maintaining optimal therapeutic outcomes. Each vial of elelyso provides 200 units of taliglucerase alfa and is intended for single use only. Taliglucerase alfa is usually given every other week. Introduction17 taliglucerase alfa for injection elelyso, a hydrolytic lysosomal glucocerebrosidespecific enzyme, was approved by the u. Jan 03, 2017 elelyso taliglucerase alfa for intravenous injection. To learn more about pfizers assistance programs or to be. Taliglucerase alfa bluecross blueshield of tennessee. Taliglucerase alfa rat oral ld 50 500 mgkg 39 weeks monkey no route specified27. After a single dose by intravenous infusion over 1 to 2 hours at a.
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