Peringatan Keamanan

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.

Idursulfase

DB01271

biotech approved

Deskripsi

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.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) 44 ± 19 minutes
Volume Distribusi -
Klirens (Clearance) * 3 mL/min/kg [Patients (7.7 – 27 years) with Hunter syndrome with treatment week 1(0.5 mg/kg ELAPRASE administered weekly as a 3-hour infusion)] * 3.4 mL/min/kg [patients (7.7 – 27 years) with Hunter syndrome with treatment week 27 (0.5 mg/kg ELAPRASE administered weekly as a 3-hour infusion)]

Absorpsi

Data absorpsi tidak tersedia.

Metabolisme

Data metabolisme tidak tersedia.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

0 Data
Tidak ada data.

Target Protein

Dermatan sulfate
Heparan sulfate
Perilipin-3 PLIN3

Referensi & Sumber

Artikel (PubMed)
  • PMID: 17459751
    Garcia AR, DaCosta JM, Pan J, Muenzer J, Lamsa JC: Preclinical dose ranging studies for enzyme replacement therapy with idursulfase in a knock-out mouse model of MPS II. Mol Genet Metab. 2007 Jun;91(2):183-90. Epub 2007 Apr 24.
  • PMID: 18174963
    Zareba G: Idursulfase in Hunter syndrome treatment. Drugs Today (Barc). 2007 Nov;43(11):759-67. doi: 10.1358/dot.2007.43.11.1157619.
  • PMID: 18201153
    Clarke LA: Idursulfase for the treatment of mucopolysaccharidosis II. Expert Opin Pharmacother. 2008 Feb;9(2):311-7. doi: 10.1517/14656566.9.2.311 .
  • PMID: 19707363
    Burrow TA, Leslie ND: Review of the use of idursulfase in the treatment of mucopolysaccharidosis II. Biologics. 2008 Jun;2(2):311-20.
  • PMID: 20301451
    Scarpa M: Mucopolysaccharidosis Type II .
  • PMID: 18038146
    Wraith JE, Scarpa M, Beck M, Bodamer OA, De Meirleir L, Guffon N, Meldgaard Lund A, Malm G, Van der Ploeg AT, Zeman J: Mucopolysaccharidosis type II (Hunter syndrome): a clinical review and recommendations for treatment in the era of enzyme replacement therapy. Eur J Pediatr. 2008 Mar;167(3):267-77. Epub 2007 Nov 23.

Contoh Produk & Brand

Produk: 5 • International brands: 0
Produk
  • Elaprase
    Solution, concentrate • 6 mg/3mL • Intravenous • US • Approved
  • Elaprase
    Solution • 2 mg / mL • Intravenous • Canada • Approved
  • Elaprase
    Injection, solution, concentrate • 2 mg/ml • Intravenous • EU • Approved
  • Elaprase
    Injection, solution, concentrate • 2 mg/ml • Intravenous • EU • Approved
  • Elaprase
    Injection, solution, concentrate • 2 mg/ml • Intravenous • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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