Elaprase drug

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August undefined, 2024

WebFeb 4, 2014 · Elaprase, a large molecular protein, is not expected to cross the blood brain barrier when administered intravenously. A revised formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. WebMay 17, 2006 · Elaprase FDA Approval History. FDA Approved: Yes (First approved July 24, 2006) Brand name: Elaprase. Generic name: idursulfase. Dosage form: Injection. Company: Shire plc. Treatment for: Mucopolysaccharidosis Type II. Elaprase (idursulfase) is a purified form of the human lysosomal enzyme iduronate-2-sulfatase produced by …

Elaprase Dosage Guide - Drugs.com

WebAlternative drugs to, pros and cons of the 2 drugs: Elaprase (2,156 reports) Abitrexate (35 reports) How the study uses the data? The study uses data from the FDA. It is based on idursulfase and methotrexate sodium (the active ingredients of Elaprase and Abitrexate, respectively), and Elaprase and Abitrexate (the brand names). Other drugs that ... WebSeven out of 10 high-expenditure drugs had substantial 2024 net price increases that were not supported by new clinical evidence; these increases accounted for $805 million in … lap informasi

MassHealth Drug List - Health and Human Services

WebElaprase Vial - Uses, Side Effects, and More Generic Name (S): idursulfase View Free Coupon Uses Side Effects Precautions Interactions Overdose Images Reviews (0) Uses Consult your... WebJun 15, 2009 · Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal ... WebELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in these patients. … la pine water bill

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Elaprase: Package Insert - Drugs.com

WebFood and Drug Administration Silver Spring MD 20993 BLA 125151/152 . BLA 125151/184 . SUPPLEMENT APPROVAL . ACCELERATED APPROVAL . FULFILLMENT OF POSTMARKETING . ... 2012, submitted under section 351(a) of the Public Health Service Act for Elaprase (idursulfase). We acknowledge receipt of your amendments … WebElaprase (idursulfase) is only available as an IV infusion that’s given by a healthcare provider. The dose of this medication depends on your weight. In general, the dosing of … hendley robertWebJul 24, 2006 · Drug Approvals and Databases Drugs@FDA Elaprase (Indursulfase) Injection Company: Shire Human Genetic Therapies, Inc. Application No.: 125151 … hendley matthew md

"WebELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months ... 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose - … " - Elaprase drug

Elaprase drug

Side Effects of Elaprase (Idursulfase Solution), …

WebJan 28, 2024 · Elaprase Drug Insight, 2024 highlights the drug marketed details and the Global API Manufacturers details across the globe along with the location. The report covers the Global Market Assessment ... WebIdursulfase (brand name Elaprase ), manufactured by Takeda, is a drug used to treat Hunter syndrome (also called MPS-II ). [1] It is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line.

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WebThis document addresses Elaprase (idursulfase), an enzyme replacement therapy approved by the Food and Drug Administration (FDA) to treat individuals with Mucopolysaccharidosis II (Hunter syndrome). The mucopolysaccharidoses are a group of inherited metabolic diseases caused by the deficiency of lysosomal enzymes needed to WebElaprase (idursulfase) dosing, indications, interactions, adverse effects, and more Drugs & Diseases idursulfase (Rx) Brand and Other Names: Elaprase Classes: Enzymes, …

WebMay 16, 2007 · Idursulfase is a purified lysosomal enzyme used as a replacement therapy for Hunter syndrome in pediatric and adult patients. Brand Names Elaprase Generic … WebDec 15, 2024 · Elaprase is used to treat patients with Hunter syndrome. It is designed for long-term use. Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients. Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase. This enzyme is needed to break down ...

WebDetermine the amount of drug solution needed to provide the dose. The number of needed drug vials is based on the patient's weight in kg times the recommended dose of 0.5 mg/kg. There are 6 mg of idursulfase per vial at a concentration of 2 mg/mL. Round up to determine the number of whole vials needed to provide the dose. WebFeb 28, 2024 · In this open label, single arm study, all participants will receive ELAPRASE treatment and a prophylactic ITR. Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. ... Participant has received treatment with any investigational drug within the 30 days prior to ...

WebDec 5, 2024 · Elaprase (idursulfase) Solution for Intravenous Infusion is an enzyme used to treat some of the symptoms of a genetic condition called Hunter syndrome (also called …

WebMassHealth Supplemental Rebate/Preferred Drug List. Link to the list of drugs preferred by MassHealth based on supplemental rebate agreements between MassHealth and drug … hendley real estateWebElaprase. A total of 0 drugs are known to interact with Elaprase. Elaprase is in the drug class lysosomal enzymes. Elaprase is used to treat Mucopolysaccharidosis Type II. Drug and food interactions. No alcohol/food interactions were found. However, this does not necessarily mean no interactions exist. ... lap infant southwest bookingWebElaprase is specifically indicated for the treatment of Hunter syndrome in adults and children ages 5 and older. The drug has been shown to improve walking capacity in these subjects. Elaprase is supplied as sterile, aqueous clear to slightly-opalescent colorless solution for intravenous infusion. hendley properties planters rowWebThis page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. It provides the criteria used to determine the … lapin he33WebApr 15, 2024 · 3. Elaprase (idursulfase): Elaprase is a medication used to treat a rare genetic disorder called Hunter syndrome, which causes the buildup of certain chemicals in the body. The cost of... hendley properties statesboro georgiaWebThe active substance in ELAPRASE is an enzyme that breaks down glycosaminoglycans (GAGs) that accumulate inside people with Hunter syndrome, causing the signs and … hendley property improvementWebElaprase is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Shire Human Genetics Therapies, Inc. It is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for the treatment of Hunter syndrome (Mucopolysaccharidosis II, MPS II). hendley properties inc