Peringatan Keamanan

Data regarding overdoses of agalsidase alfa are not readily available.L16398 Patients experiencing an overdose of agalsidase alfa may experience an increased incidence and severity of adverse effects. Overdose can be managed through the use of symptomatic and supportive measures.

Agalsidase alfa

DB15874

biotech approved

Deskripsi

Agalsidase alfa is a recombinant human ?-galactosidase A similar to agalsidase beta. 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 alfa was granted EMA approval on 3 August 2001.L16413

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) The elimination half life was 108 ± 17 minutes for males and 89 ± 28 minutes for females.[L16398]
Volume Distribusi The volume of distribution at steady state in non end stage renal disease patients was approximately 17% of body weight regardless of sex.[A220338,L16398]
Klirens (Clearance) The clearance for doses of 0.007-0.2 mg/kg were 2.66 mL/min/kg for males and 2.10 mL/min/kg for females.[L16398]

Absorpsi

A dose of agalsidase alfa in non end stage renal disease patients reaches a Cmax of 3710 ± 855 U/mL with an AUC of 256,958 ± 63,499 min\*U/mL.A220338

Metabolisme

Data regarding the metabolism of agalsidase alfa is not readily available.L16398 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

6 Data
Chloroquine The therapeutic efficacy of Agalsidase alfa can be decreased when used in combination with Chloroquine.
Amiodarone The therapeutic efficacy of Agalsidase alfa can be decreased when used in combination with Amiodarone.
Monobenzone The therapeutic efficacy of Agalsidase alfa can be decreased when used in combination with Monobenzone.
Gentamicin The therapeutic efficacy of Agalsidase alfa can be decreased when used in combination with Gentamicin.
Agalsidase beta The therapeutic efficacy of Agalsidase beta can be decreased when used in combination with Agalsidase alfa.
Migalastat The serum concentration of Agalsidase alfa can be increased when it is combined with Migalastat.

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: 17395657
    Pastores GM, Boyd E, Crandall K, Whelan A, Piersall L, Barnett N: Safety and pharmacokinetics of agalsidase alfa in patients with Fabry disease and end-stage renal disease. Nephrol Dial Transplant. 2007 Jul;22(7):1920-5. doi: 10.1093/ndt/gfm096. Epub 2007 Mar 29.
  • 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

Produk: 5 • International brands: 0
Produk
  • Alpha Galactosidase
    Capsule • 600 umol/1 • Oral • US
  • Replagal
    Injection, solution, concentrate • 1 mg/ml • Intravenous • EU • Approved
  • Replagal
    Injection, solution, concentrate • 1 mg/ml • Intravenous • EU • Approved
  • Replagal
    Injection, solution, concentrate • 1 mg/ml • Intravenous • EU • Approved
  • Replagal
    Solution • 1 mg / mL • Intravenous • Canada • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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