Peringatan Keamanan

rIX-RFP is very well tolerated.A32547Mutaginicity trials were performed and they confirmed an absent mutagenic potential.L2305Fertility studies have not been performed. Developmental studies are not of major importance as there is a very low rate of incidence of hemophilia B in females.

Albutrepenonacog alfa

DB13884

biotech approved

Deskripsi

Albutrepenonacog alfa (rIX-RFP) is a recombinant fusion protein that links a recombinant coagulation factor IX (rFIX) with a recombinant human albumin (rAlbumin).A32547 It was developed by CSL Behring Canada, Inc and approved by Health Canada on April 26, 2017. It was also approved by FDA and EMA in 2016. It is currently marketed in the forms of 250, 500, 1000 and 2000 IU/vial.L2305

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 fusion of the rFIX with rAlbumin prolongs the elimination half-life of rIX-RFP in the circulation. The reported half-life in clinical trials is 92 hours.[A32547]
Volume Distribusi The reported volume of distribution for rIX-RFP according to phase I/II and III clinical trials is 95 ml/kg.[A32556]
Klirens (Clearance) In clinical trials, the weight-adjusted clearance in children and adults is reported to be 1.1 and 0.9 ml/h/kg.[A32547]

Absorpsi

rIX-RFP absorption is very rapid as it is directly administered intravenously. In clinical trials, the maximum plasma concentration, area under the curve and mean residence time are reported to be approximately 55 IU/dL, 5500 IU.h/dL and 125 hours respectively.A32547

Metabolisme

The metabolism of rIX-RFP is not relevant as it is a recombinant protein and it is thought to be metabolized to peptides and amino acids.L2313

Rute Eliminasi

rIX-RFP is mainly eliminated in the urine. In preclinical studies, the distribution of urine and feces 240 hours post administration corresponded to 72.9% and 4.3% of the administered dose respectively. The elimination on the first 24 hours in urine and feces only corresponded to the 39.9% and 0.92% of the dose.L2313

Interaksi Obat

810 Data
Aminocaproic acid The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Albutrepenonacog alfa.
Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Albutrepenonacog alfa.
Menadione Menadione may increase the thrombogenic activities of Albutrepenonacog alfa.
Tranexamic acid Tranexamic acid may increase the thrombogenic activities of Albutrepenonacog alfa.
Aprotinin Aprotinin may increase the thrombogenic activities of Albutrepenonacog alfa.
Hydrogen peroxide Hydrogen peroxide may increase the thrombogenic activities of Albutrepenonacog alfa.
Aminomethylbenzoic acid Aminomethylbenzoic acid may increase the thrombogenic activities of Albutrepenonacog alfa.
Camostat Camostat may increase the thrombogenic activities of Albutrepenonacog alfa.
Menadione bisulfite Menadione bisulfite may increase the thrombogenic activities of Albutrepenonacog alfa.
Alteplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Alteplase.
Urokinase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Urokinase.
Reteplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Reteplase.
Anistreplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Anistreplase.
Tenecteplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Tenecteplase.
Drotrecogin alfa The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Drotrecogin alfa.
Streptokinase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Streptokinase.
Dicoumarol The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dicoumarol.
Desmoteplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Desmoteplase.
Defibrotide The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Defibrotide.
Ancrod The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ancrod.
Sulodexide The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Sulodexide.
Astaxanthin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Astaxanthin.
Amediplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Amediplase.
Protein C The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Protein C.
Monteplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Monteplase.
Brinase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Brinase.
Saruplase The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Saruplase.
Lepirudin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Lepirudin.
Bivalirudin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Bivalirudin.
Ardeparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ardeparin.
Phenindione The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Phenindione.
Warfarin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Warfarin.
Pentosan polysulfate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Pentosan polysulfate.
Phenprocoumon The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Phenprocoumon.
Dipyridamole The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dipyridamole.
Heparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Heparin.
Enoxaparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Enoxaparin.
Epoprostenol The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Epoprostenol.
Acenocoumarol The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Acenocoumarol.
4-hydroxycoumarin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with 4-hydroxycoumarin.
Coumarin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Coumarin.
Ximelagatran The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ximelagatran.
Beraprost The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Beraprost.
Prasugrel The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Prasugrel.
Rivaroxaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Rivaroxaban.
Idraparinux The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Idraparinux.
Cangrelor The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Cangrelor.
Apixaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Apixaban.
Otamixaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Otamixaban.
Dabigatran etexilate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dabigatran etexilate.
(R)-warfarin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with (R)-warfarin.
Ethyl biscoumacetate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ethyl biscoumacetate.
Nadroparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Nadroparin.
Triflusal The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Triflusal.
Ticagrelor The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ticagrelor.
Ditazole The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Ditazole.
Vorapaxar The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Vorapaxar.
Potassium citrate Potassium citrate may increase the excretion rate of Albutrepenonacog alfa which could result in a lower serum level and potentially a reduction in efficacy.
Sodium citrate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Sodium citrate.
Dextran The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dextran.
Bemiparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Bemiparin.
Parnaparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Parnaparin.
Desirudin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Desirudin.
Antithrombin Alfa The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Antithrombin Alfa.
Antithrombin III human The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Antithrombin III human.
Letaxaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Letaxaban.
Darexaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Darexaban.
Betrixaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Betrixaban.
Nafamostat The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Nafamostat.
Gabexate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Gabexate.
Fluindione The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Fluindione.
Protein S human The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Protein S human.
Clorindione The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Clorindione.
Diphenadione The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Diphenadione.
Tioclomarol The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Tioclomarol.
Melagatran The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Melagatran.
(S)-Warfarin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with (S)-Warfarin.
Tocopherylquinone The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Tocopherylquinone.
Dabigatran The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dabigatran.
Semuloparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Semuloparin.
Troxerutin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Troxerutin.
Edetic acid The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Edetic acid.
Reviparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Reviparin.
Dermatan sulfate The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dermatan sulfate.
Abciximab The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Abciximab.
Argatroban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Argatroban.
Fondaparinux The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Fondaparinux.
Danaparoid The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Danaparoid.
Dalteparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Dalteparin.
Tinzaparin The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Tinzaparin.
Edoxaban The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with Edoxaban.
SR-123781A The therapeutic efficacy of Albutrepenonacog alfa can be decreased when used in combination with SR-123781A.
Cyclosporine Cyclosporine may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Icosapent Icosapent may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Cefotiam Cefotiam may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Mesalazine Mesalazine may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Cefmenoxime Cefmenoxime may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Cefmetazole Cefmetazole may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Pamidronic acid Pamidronic acid may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Tenofovir disoproxil Tenofovir disoproxil may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.

Target Protein

Coagulation factor X F10

Referensi & Sumber

Artikel (PubMed)
  • PMID: 27988873
    Lyseng-Williamson KA: Coagulation Factor IX (Recombinant), Albumin Fusion Protein (Albutrepenonacog Alfa; Idelvion((R))): A Review of Its Use in Haemophilia B. Drugs. 2017 Jan;77(1):97-106. doi: 10.1007/s40265-016-0679-8.
  • PMID: 27099538
    Nazeef M, Sheehan JP: New developments in the management of moderate-to-severe hemophilia B. J Blood Med. 2016 Apr 1;7:27-38. doi: 10.2147/JBM.S81520. eCollection 2016.
  • PMID: 25851415
    Goodeve AC: Hemophilia B: molecular pathogenesis and mutation analysis. J Thromb Haemost. 2015 Jul;13(7):1184-95. doi: 10.1111/jth.12958. Epub 2015 May 18.
  • PMID: 27677190
    Morfini M: Pharmacokinetic drug evaluation of albutrepenonacog alfa (CSL654) for the treatment of hemophilia. Expert Opin Drug Metab Toxicol. 2016 Oct 2:1-7. doi: 10.1080/17425255.2016.1240168.

Contoh Produk & Brand

Produk: 12 • International brands: 1
Produk
  • Idelvion
    Kit; Powder, for solution • 3500 unit / vial • Intravenous • Canada • Approved
  • Idelvion
    Injection, powder, lyophilized, for solution; Kit • 250 [iU]/2.5mL • Intravenous • US • Approved
  • Idelvion
    Injection, powder, for solution • 250 IU • Intravenous • EU • Approved
  • Idelvion
    Injection, powder, lyophilized, for solution; Kit • 500 [iU]/2.5mL • Intravenous • US • Approved
  • Idelvion
    Injection, powder, for solution • 500 IU • Intravenous • EU • Approved
  • Idelvion
    Injection, powder, lyophilized, for solution; Kit • 1000 [iU]/2.5mL • Intravenous • US • Approved
  • Idelvion
    Injection, powder, for solution • 1000 IU • Intravenous • EU • Approved
  • Idelvion
    Injection, powder, lyophilized, for solution; Kit • 2000 [iU]/5mL • Intravenous • US • Approved
Menampilkan 8 dari 12 produk.
International Brands
  • IDELVION — CSL Behring

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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