Peringatan Keamanan

There is currently no data for imlifidase administered at supra-therapeutic doses; therefore, toxicity information is not readily available.L28001 In cases of overdose, the patient should be carefully monitored and symptomatic treatment should be initiated as needed.L28001 Although there is no antidote to imlifidase, administration of intravenous IgG may correct depleted IgG levels.L28001

Imlifidase

DB15258

biotech approved investigational

Deskripsi

Chronic kidney disease (CKD) is a progressive and irreversible disease that represents a significant burden for both the individual and healthcare system at large.A225916 Currently available treatments for end-stage renal disease are limited to dialysis and renal transplantation, with the former associated with significant costs and lower quality of life.A225836,A225916

Patients who have developed human leukocyte antigen (HLA) sensitization from prior exposure to blood products, pregnancy, or any other circumstance which may have resulted in exposure to non-self HLA antigens, face additional barriers to transplantation.A225836,A225921 Highly sensitized individuals carry high levels of anti-HLA antibodies and are at significant risk for antibody-mediated rejection which occurs mainly through complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).A225836 High levels of anti-HLA antibodies also contribute to poor graft survival.A225836 As a result, highly sensitized individuals experience marked delays on transplant lists due to the challenges associated with procuring an HLA compatible donor graft.A225836,A225921

Imlifidase is a cysteine protease and eliminates Fc-dependent effector functions such as CDC and ADCC by cleaving the heavy chains of human immunoglobulin G (IgG) antibodies.L28001 As a result, the risk of antibody-mediated rejection is reduced allowing kidney transplantation in highly sensitized patients to proceed.A225836,L28001

Struktur Molekul 2D

Struktur tidak tersedia

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

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean distribution half-life of imlifidase is reported to be 1.8 hours, while the mean elimination half-life is reported to be 89 hours.[A225836]
Volume Distribusi The volume of distribution of imlifidase is reported to be 0.2 L/kg in the elimination phase.[A225836]
Klirens (Clearance) The mean clearance value of imlifidase is reported to be 1.8 mL/h/kg.[A225836]

Absorpsi

Given that imlifidase is administered intravenously, it is fully absorbed and bioavailable; imlifidase exposure is dose-proportional and predictable.A225836,L28001 After a dose of 0.25 mg/kg, the mean Cmax of imlifidase was 5.8 (4.2-8.9) ug/mL.L28001 Tmax occurs once infusion is complete or soon after.A225836 Food is not expected to impact the effectiveness or absorption of imlifidase.L28001

Metabolisme

There is currently no imlifidase metabolism data available; however, it is thought to be eliminated via proteolysis.L28041

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

194 Data
Human immunoglobulin G The therapeutic efficacy of Imlifidase can be decreased when used in combination with Human immunoglobulin G.
Cetuximab The therapeutic efficacy of Cetuximab can be decreased when used in combination with Imlifidase.
Omalizumab The therapeutic efficacy of Omalizumab can be decreased when used in combination with Imlifidase.
Adalimumab The therapeutic efficacy of Adalimumab can be decreased when used in combination with Imlifidase.
Abciximab The therapeutic efficacy of Abciximab can be decreased when used in combination with Imlifidase.
Gemtuzumab ozogamicin The therapeutic efficacy of Gemtuzumab ozogamicin can be decreased when used in combination with Imlifidase.
Infliximab The therapeutic efficacy of Infliximab can be decreased when used in combination with Imlifidase.
Trastuzumab The therapeutic efficacy of Trastuzumab can be decreased when used in combination with Imlifidase.
Rituximab The therapeutic efficacy of Rituximab can be decreased when used in combination with Imlifidase.
Basiliximab The therapeutic efficacy of Basiliximab can be decreased when used in combination with Imlifidase.
Muromonab The therapeutic efficacy of Muromonab can be decreased when used in combination with Imlifidase.
Alemtuzumab The therapeutic efficacy of Alemtuzumab can be decreased when used in combination with Imlifidase.
Efalizumab The therapeutic efficacy of Efalizumab can be decreased when used in combination with Imlifidase.
Natalizumab The therapeutic efficacy of Natalizumab can be decreased when used in combination with Imlifidase.
Palivizumab The therapeutic efficacy of Palivizumab can be decreased when used in combination with Imlifidase.
Daclizumab The therapeutic efficacy of Daclizumab can be decreased when used in combination with Imlifidase.
Bevacizumab The therapeutic efficacy of Bevacizumab can be decreased when used in combination with Imlifidase.
Panitumumab The therapeutic efficacy of Panitumumab can be decreased when used in combination with Imlifidase.
Ranibizumab The therapeutic efficacy of Ranibizumab can be decreased when used in combination with Imlifidase.
Pexelizumab The therapeutic efficacy of Pexelizumab can be decreased when used in combination with Imlifidase.
Epratuzumab The therapeutic efficacy of Epratuzumab can be decreased when used in combination with Imlifidase.
Labetuzumab The therapeutic efficacy of Labetuzumab can be decreased when used in combination with Imlifidase.
Matuzumab The therapeutic efficacy of Matuzumab can be decreased when used in combination with Imlifidase.
Fontolizumab The therapeutic efficacy of Fontolizumab can be decreased when used in combination with Imlifidase.
Otelixizumab The therapeutic efficacy of Otelixizumab can be decreased when used in combination with Imlifidase.
Enokizumab The therapeutic efficacy of Enokizumab can be decreased when used in combination with Imlifidase.
Ramucirumab The therapeutic efficacy of Ramucirumab can be decreased when used in combination with Imlifidase.
Farletuzumab The therapeutic efficacy of Farletuzumab can be decreased when used in combination with Imlifidase.
Veltuzumab The therapeutic efficacy of Veltuzumab can be decreased when used in combination with Imlifidase.
Ustekinumab The therapeutic efficacy of Ustekinumab can be decreased when used in combination with Imlifidase.
Trastuzumab emtansine The therapeutic efficacy of Trastuzumab emtansine can be decreased when used in combination with Imlifidase.
TNX-901 The therapeutic efficacy of TNX-901 can be decreased when used in combination with Imlifidase.
Inotuzumab ozogamicin The therapeutic efficacy of Inotuzumab ozogamicin can be decreased when used in combination with Imlifidase.
RI 624 The therapeutic efficacy of RI 624 can be decreased when used in combination with Imlifidase.
Leronlimab The therapeutic efficacy of Leronlimab can be decreased when used in combination with Imlifidase.
Olaratumab The therapeutic efficacy of Olaratumab can be decreased when used in combination with Imlifidase.
Eldelumab The therapeutic efficacy of Eldelumab can be decreased when used in combination with Imlifidase.
Ipilimumab The therapeutic efficacy of Ipilimumab can be decreased when used in combination with Imlifidase.
Nimotuzumab The therapeutic efficacy of Nimotuzumab can be decreased when used in combination with Imlifidase.
Tocilizumab The therapeutic efficacy of Tocilizumab can be decreased when used in combination with Imlifidase.
Motavizumab The therapeutic efficacy of Motavizumab can be decreased when used in combination with Imlifidase.
Elotuzumab The therapeutic efficacy of Elotuzumab can be decreased when used in combination with Imlifidase.
AVE9633 The therapeutic efficacy of AVE9633 can be decreased when used in combination with Imlifidase.
XmAb 2513 The therapeutic efficacy of XmAb 2513 can be decreased when used in combination with Imlifidase.
Coltuximab ravtansine The therapeutic efficacy of Coltuximab ravtansine can be decreased when used in combination with Imlifidase.
Lucatumumab The therapeutic efficacy of Lucatumumab can be decreased when used in combination with Imlifidase.
Pertuzumab The therapeutic efficacy of Pertuzumab can be decreased when used in combination with Imlifidase.
Siplizumab The therapeutic efficacy of Siplizumab can be decreased when used in combination with Imlifidase.
Apolizumab The therapeutic efficacy of Apolizumab can be decreased when used in combination with Imlifidase.
Sibrotuzumab The therapeutic efficacy of Sibrotuzumab can be decreased when used in combination with Imlifidase.
Bivatuzumab The therapeutic efficacy of Bivatuzumab can be decreased when used in combination with Imlifidase.
Reslizumab The therapeutic efficacy of Reslizumab can be decreased when used in combination with Imlifidase.
Teplizumab The therapeutic efficacy of Teplizumab can be decreased when used in combination with Imlifidase.
Catumaxomab The therapeutic efficacy of Catumaxomab can be decreased when used in combination with Imlifidase.
Mepolizumab The therapeutic efficacy of Mepolizumab can be decreased when used in combination with Imlifidase.
Denosumab The therapeutic efficacy of Denosumab can be decreased when used in combination with Imlifidase.
Ofatumumab The therapeutic efficacy of Ofatumumab can be decreased when used in combination with Imlifidase.
Golimumab The therapeutic efficacy of Golimumab can be decreased when used in combination with Imlifidase.
Brentuximab vedotin The therapeutic efficacy of Brentuximab vedotin can be decreased when used in combination with Imlifidase.
Belimumab The therapeutic efficacy of Belimumab can be decreased when used in combination with Imlifidase.
Obinutuzumab The therapeutic efficacy of Obinutuzumab can be decreased when used in combination with Imlifidase.
Vedolizumab The therapeutic efficacy of Vedolizumab can be decreased when used in combination with Imlifidase.
Nivolumab The therapeutic efficacy of Nivolumab can be decreased when used in combination with Imlifidase.
Pembrolizumab The therapeutic efficacy of Pembrolizumab can be decreased when used in combination with Imlifidase.
Blinatumomab The therapeutic efficacy of Blinatumomab can be decreased when used in combination with Imlifidase.
Dinutuximab The therapeutic efficacy of Dinutuximab can be decreased when used in combination with Imlifidase.
Idarucizumab The therapeutic efficacy of Idarucizumab can be decreased when used in combination with Imlifidase.
Alirocumab The therapeutic efficacy of Alirocumab can be decreased when used in combination with Imlifidase.
Evolocumab The therapeutic efficacy of Evolocumab can be decreased when used in combination with Imlifidase.
Daratumumab The therapeutic efficacy of Daratumumab can be decreased when used in combination with Imlifidase.
Necitumumab The therapeutic efficacy of Necitumumab can be decreased when used in combination with Imlifidase.
Ixekizumab The therapeutic efficacy of Ixekizumab can be decreased when used in combination with Imlifidase.
Ravulizumab The therapeutic efficacy of Ravulizumab can be decreased when used in combination with Imlifidase.
Atezolizumab The therapeutic efficacy of Atezolizumab can be decreased when used in combination with Imlifidase.
Durvalumab The therapeutic efficacy of Durvalumab can be decreased when used in combination with Imlifidase.
Bapineuzumab The therapeutic efficacy of Bapineuzumab can be decreased when used in combination with Imlifidase.
Depatuxizumab mafodotin The therapeutic efficacy of Depatuxizumab mafodotin can be decreased when used in combination with Imlifidase.
Solanezumab The therapeutic efficacy of Solanezumab can be decreased when used in combination with Imlifidase.
Sarilumab The therapeutic efficacy of Sarilumab can be decreased when used in combination with Imlifidase.
Brodalumab The therapeutic efficacy of Brodalumab can be decreased when used in combination with Imlifidase.
Emibetuzumab The therapeutic efficacy of Emibetuzumab can be decreased when used in combination with Imlifidase.
Ligelizumab The therapeutic efficacy of Ligelizumab can be decreased when used in combination with Imlifidase.
Landogrozumab The therapeutic efficacy of Landogrozumab can be decreased when used in combination with Imlifidase.
Vadastuximab talirine The therapeutic efficacy of Vadastuximab talirine can be decreased when used in combination with Imlifidase.
Avelumab The therapeutic efficacy of Avelumab can be decreased when used in combination with Imlifidase.
Ocrelizumab The therapeutic efficacy of Ocrelizumab can be decreased when used in combination with Imlifidase.
Benralizumab The therapeutic efficacy of Benralizumab can be decreased when used in combination with Imlifidase.
Visilizumab The therapeutic efficacy of Visilizumab can be decreased when used in combination with Imlifidase.
Gevokizumab The therapeutic efficacy of Gevokizumab can be decreased when used in combination with Imlifidase.
Simtuzumab The therapeutic efficacy of Simtuzumab can be decreased when used in combination with Imlifidase.
Fasinumab The therapeutic efficacy of Fasinumab can be decreased when used in combination with Imlifidase.
Dupilumab The therapeutic efficacy of Dupilumab can be decreased when used in combination with Imlifidase.
Etrolizumab The therapeutic efficacy of Etrolizumab can be decreased when used in combination with Imlifidase.
Etaracizumab The therapeutic efficacy of Etaracizumab can be decreased when used in combination with Imlifidase.
Aducanumab The therapeutic efficacy of Aducanumab can be decreased when used in combination with Imlifidase.
Labetuzumab govitecan The therapeutic efficacy of Labetuzumab govitecan can be decreased when used in combination with Imlifidase.
Tanezumab The therapeutic efficacy of Tanezumab can be decreased when used in combination with Imlifidase.
Bococizumab The therapeutic efficacy of Bococizumab can be decreased when used in combination with Imlifidase.
Mirvetuximab soravtansine The therapeutic efficacy of Mirvetuximab Soravtansine can be decreased when used in combination with Imlifidase.
Mogamulizumab The therapeutic efficacy of Mogamulizumab can be decreased when used in combination with Imlifidase.

Target Protein

IgG heavy chain IGHG1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 33058042
    Al-Salama ZT: Imlifidase: First Approval. Drugs. 2020 Nov;80(17):1859-1864. doi: 10.1007/s40265-020-01418-5.
  • PMID: 27822135
    Fraser SD, Blakeman T: Chronic kidney disease: identification and management in primary care. Pragmat Obs Res. 2016 Aug 17;7:21-32. doi: 10.2147/POR.S97310. eCollection 2016.
  • PMID: 25062962
    Rees L, Kim JJ: HLA sensitisation: can it be prevented? Pediatr Nephrol. 2015 Apr;30(4):577-87. doi: 10.1007/s00467-014-2868-6. Epub 2014 Jul 26.
  • PMID: 29561066
    Lorant T, Bengtsson M, Eich T, Eriksson BM, Winstedt L, Jarnum S, Stenberg Y, Robertson AK, Mosen K, Bjorck L, Backman L, Larsson E, Wood K, Tufveson G, Kjellman C: Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733. Epub 2018 Apr 17.
  • PMID: 26177518
    Winstedt L, Jarnum S, Nordahl EA, Olsson A, Runstrom A, Bockermann R, Karlsson C, Malmstrom J, Palmgren GS, Malmqvist U, Bjorck L, Kjellman C: Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. eCollection 2015.

Contoh Produk & Brand

Produk: 2 • International brands: 1
Produk
  • Idefirix
    Injection, powder, for solution • 11 mg • Intravenous • EU • Approved
  • Idefirix
    Injection • 11 mg • Intravenous • EU • Approved
International Brands
  • Idefirix

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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