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Idursulfase

Generic Name
Idursulfase
Brand Names
Elaprase
Drug Type
Biotech
CAS Number
50936-59-9
Unique Ingredient Identifier
5W8JGG2651

Overview

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 lysosomes of various cell types. Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains eight asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent on the post-translational modification of a specific cysteine to formylglycine.

Background

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 lysosomes of various cell types. Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains eight asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent on the post-translational modification of a specific cysteine to formylglycine.

Indication

For the treatment of Hunter syndrome in adults and children ages 5 and older.

Associated Conditions

  • Mucopolysaccharidosis Type II (MPS II)

FDA Approved Products

ELAPRASE
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:INTRAVENOUS
Strength:6 mg in 3 mL
Approved: 2021/09/30
NDC:54092-700

Singapore Approved Products

Elaprase (TM) Solution for Intravenous Infusion 2mg/ ml
Manufacturer:Shire HGT, Inc, Vetter Pharma-Fertigung GmbH & Co. KG (fill-finish)
Form:INFUSION, SOLUTION CONCENTRATE
Strength:6.0 mg/vial
Online:Yes
Approved: 2010/12/24
Approval:SIN13902P

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