Peringatan Keamanan

Data regarding overdoses of agalsidase beta are not readily available.L16383 Patients experiencing an overdose of agalsidase beta may experience an increased incidence and severity of adverse effects.L16383 Overdose can be managed through the use of symptomatic and supportive measures.

Agalsidase beta

DB00103

biotech approved investigational

Deskripsi

Agalsidase beta is a recombinant human ?-galactosidase A similar to agalsidase alfa. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta.A220228,A220233 Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009.A220343

Agalsidase beta was granted FDA approval on 24 April 2003.L16383

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) agalsidase beta has a half like of 67 ± 12 min for a 1 mg/kg dose with a mean infusion length of 115 minutes.[L16383]
Volume Distribusi A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes has a V<sub>SS</sub> of 112 ± 13 mL/kg.[L16383]
Klirens (Clearance) A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes has a clearance of 2.1 ± 0.7 mL/min/kg.[L16383]

Absorpsi

A 1 mg/kg dose of agalsidase beta with a mean infusion length of 115 minutes reaches a Cmax 5.0 ± 1.1 µg/mL with an AUC of 496 ± 137 µg\*min/mL.L16383

Metabolisme

Data regarding the metabolism of agalsidase beta is not readily available.L16383 However, protein drugs are expected to be degraded by proteases and other catalytic enzymes to smaller peptides and amino acids.A182009

Rute Eliminasi

After nonspecific proteolysis, the amino acids from protein drugs are reused for protein synthesis or further broken down and eliminated by the kidneys.A182009

Interaksi Obat

4 Data
Chloroquine The therapeutic efficacy of Agalsidase beta can be decreased when used in combination with Chloroquine.
Gentamicin The therapeutic efficacy of Agalsidase beta can be decreased when used in combination with Gentamicin.
Amiodarone The therapeutic efficacy of Agalsidase beta can be decreased when used in combination with Amiodarone.
Agalsidase alfa The therapeutic efficacy of Agalsidase beta can be decreased when used in combination with Agalsidase alfa.

Target Protein

Globotriaosylceramide

Referensi & Sumber

Artikel (PubMed)
  • PMID: 30775256
    Germain DP, Elliott PM, Falissard B, Fomin VV, Hilz MJ, Jovanovic A, Kantola I, Linhart A, Mignani R, Namdar M, Nowak A, Oliveira JP, Pieroni M, Viana-Baptista M, Wanner C, Spada M: The effect of enzyme replacement therapy on clinical outcomes in male patients with Fabry disease: A systematic literature review by a European panel of experts. Mol Genet Metab Rep. 2019 Feb 6;19:100454. doi: 10.1016/j.ymgmr.2019.100454. eCollection 2019 Jun.
  • PMID: 28510034
    Wilcox WR, Feldt-Rasmussen U, Martins AM, Ortiz A, Lemay RM, Jovanovic A, Germain DP, Varas C, Nicholls K, Weidemann F, Hopkin RJ: Improvement of Fabry Disease-Related Gastrointestinal Symptoms in a Significant Proportion of Female Patients Treated with Agalsidase Beta: Data from the Fabry Registry. JIMD Rep. 2018;38:45-51. doi: 10.1007/8904201728. Epub 2017 May 17.
  • PMID: 22768187
    Prabakaran T, Nielsen R, Satchell SC, Mathieson PW, Feldt-Rasmussen U, Sorensen SS, Christensen EI: Mannose 6-phosphate receptor and sortilin mediated endocytosis of alpha-galactosidase A in kidney endothelial cells. PLoS One. 2012;7(6):e39975. doi: 10.1371/journal.pone.0039975. Epub 2012 Jun 29.
  • PMID: 21698655
    Katsila T, Siskos AP, Tamvakopoulos C: Peptide and protein drugs: the study of their metabolism and catabolism by mass spectrometry. Mass Spectrom Rev. 2012 Jan-Feb;31(1):110-33. doi: 10.1002/mas.20340. Epub 2011 Jun 22.
  • PMID: 25010055
    Pisani A, Riccio E, Sabbatini M: Agalsidase alfa and agalsidase beta in the treatment of Fabry disease: does the dose really matter? Genet Med. 2015 Jan;17(1):21-3. doi: 10.1038/gim.2014.79. Epub 2014 Jul 10.

Contoh Produk & Brand

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Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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