Elaprase monograph
WebJan 11, 2024 · What is Elaprase? Elaprase is an IV infusion used to treat some of the symptoms of a genetic condition called Hunter's syndrome, also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis). Idursulfase contains a natural enzyme that some people lack because of a genetic disorder. Elaprase helps … WebDec 15, 2024 · Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in …
Elaprase monograph
Did you know?
WebMay 16, 2007 · Idursulfase is a purified form of human iduronate-2-sulfatase, a lysosomal enzyme. Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans dermatan sulfate and heparan sulfate in the … WebAug 10, 2024 · Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. The prophylactic ITR will consist of a 5-week cycle of: Rituximab (intravenously [IV], weekly for 4 weeks); Methotrexate (oral, 3 times per week for 5 weeks) and intravenous immunoglobulin …
WebELAPRASE has been shown to improve walking capacity in patients 5 years and older.In patients 16 months to 5 years of age, no data are available to demonstrate improvement … WebDec 19, 2024 · ELAPRASE is an intravenous enzyme replacement therapy approved for the treatment of patients with Hunter syndrome in 70+ countries worldwide including countries in Africa, Asia Pacific, Europe, Latin America and North America. 1. In the E.U., ELAPRASE is indicated for the long-term treatment of patients with Hunter syndrome. 2
WebELAPRASE is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has … WebBlack Box Warnings. Anaphylactoid reactions, which may be life threatening, have been observed in some patients during idursulfase infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after infusions, regardless of duration of the ...
WebSep 27, 2024 · The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome. Participants will receive Elaprase once per week over a 3-hour period which can be reduced to 1 hour as determined by the study doctor. Participants will need to visit the clinic weekly during the …
WebELAPRASE ® (Idursulfase) is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical … massive actionsWebELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line. In conjunction with the market approval of ELAPRASE, Shire Human Genetic Therapies (the Shire business unit focused on genetic diseases) has introduced a new product support center called … massive afroWebElaprase (idursulfase) dosing, indications, interactions, adverse effects, and more Drugs & Diseases idursulfase (Rx) Brand and Other Names: Elaprase Classes: Enzymes, … hydro seal blister cushionsWebPediatric drug monographs for elaprase provide an overview of the product, therapeutic uses, key development issues, regulatory information on ScriptSave WellRx. massive afro hairWebEach vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution. Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use. It is recommended to deliver the total volume of infusion using a 0.2 µm in line filter. massive afro wighydro seal bandages walmartWebELAPRASE. IDURSULFASE (EYE dur SUL fase) is used to replace an enzyme that is missing in patients with Hunter syndrome. It is not a cure. ELAPRASE Monographs. … massive algorithms