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RX BIN: 015558RX PCN: HTGroup ID: DDN6600Card Holder ID: DDN6600
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2019 Price of Elaprase

$34,157.5811 vials 6mg/3ml
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Idursulfase volume of distribution

The volume of distribution at steady state (V ss) was 198 ± 191 ml/kg. Mean serum and CSF I2S concentration-time profiles with 0.5 mg/kg idursulfase intravenous dose.

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What is Idursulfase

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.

Idursulfase mechanism of action

Hunter’s Syndrome is an X-linked recessive disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. This enzyme cleaves the terminal 2-O-sulfate moieties from the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate. Due to the missing or defective iduronate-2-sulfatase enzyme in patients with Hunter’s Syndrome, GAG progressively accumulate in the lysosomes of a variety of cells, leading to cellular engorgement, organomegaly, tissue destruction and organ system dysfunction. Treatment of Hunter’s Syndrome patients with idursulfase provides exogenous enzyme for uptake into cellular lysosomes. Targeting of idursulfase to the lysosome occurs by endocytosis from the cell surface. Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow specific binding of the enzymes to the M6P receptors on the cell surface, leading to cellular internalization of the enzyme, targeting to intracellular lysosomes and subsequent catabolism of accumulated GAG.

Dosage forms of Idursulfase

FormRouteStrength
Solutionintravenous2 mg
Solution, concentrateintravenous6 mg/3mL

Prescription Generics

false

International Brands

Elaprase

Synonyms

Alpha-L-iduronate sulfate sulfatase Iduronate 2-sulfatase

Manufacturers

Shire Human Genetic Therapies Inc

CAS number

50936-59-9

UNII

5W8JGG2651

State

solid

Affected organisms

Humans and other mammals

Indication of Idursulfase

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

Toxicity of Idursulfase

There is no experience with overdosage of Idursulfase in humans. Single intravenous doses of idursulfase up to 20 mg/kg were not lethal in male rats and cynomolgus monkeys (approximately 6.5 and 13 times, respectively, of the recommended human dose based on body surface area) and there were no clinical signs of toxicity.

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