Peringatan Keamanan

There is limited information regarding acute toxicity and overdosage of nonacog beta pegol.

Nonacog beta pegol

DB13933

biotech approved investigational

Deskripsi

Nonacog beta pegol is a recombinant coagulation factor IX derivative. It is produced without animal-derived materials and with an attached 40kDa polyethylene glycol (PEG) molecule for peptide activation by a site-directed glycoPEGylation. Once activated, the activation molecule with PEG is cleaved to leave the activated factor IX (Factor IXa).^A31496 Nonacog beta pegol was developed by Novo Nordisk and received its first global approval by the FDA on May 31, 2017,^L1098 followed by the European Commission approval on June 2, 2017.^L41185 Nonacog beta pegol was approved by Health Canada on November 29, 2017.^L43682

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler

Obat Target Gen Interaksi Enzim Transporter Carrier

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

1. Pendahuluan & Konsep

Fitur visualisasi ini dikembangkan menggunakan pendekatan Graph Theory untuk memetakan hubungan polifarmasi dan molekuler. Entitas (Obat, Target, Gen) direpresentasikan sebagai Simpul (Nodes), sedangkan hubungan biologisnya sebagai Sisi (Edges).

2. Sumber Data (Validasi)

Data Obat: Diekstraksi dari elemen drugbank-id dan name pada skema XML DrugBank.
Target Protein: Diambil dari elemen targets/target yang memuat polipeptida sasaran.
Genetik: Disinkronisasi dari sub-elemen gene-name dan varian snp-effects.
Genetik: Jumlah titik node dibatasi pada maksimal 10 (Slice=10) interaksi untuk menghindari tumpukan data.

3. Algoritma Visualisasi

Tata letak grafik menggunakan algoritma Force-Directed Graph (Barnes-Hut). Model fisika ini menerapkan gaya tolak-menolak antar simpul (Gravitasi: -3000) agar tidak tumpang tindih, serta gaya pegas (Spring: 0.04) pada garis penghubung untuk fleksibilitas interaksi.

4. Legenda Visual

Obat Utama (Pusat Analisis)

Target Protein (Mekanisme)

Gen (Faktor Genetik)

Metode ini mendukung analisis Precision Medicine dan evaluasi risiko Drug-Drug Interaction (DDI).

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean half-life ranged from 70 to 89 hours in children and adults.[L43682]

Volume Distribusi The volume of distribution varies depending on the patient's age. After single administration, the volume of distribution goes from 72 ml/kg for children less than 6 years of age, 68 ml/kg for adolescents between 7 and 12 years of age, 59 ml/kg in adolescents between 13 and 17 years of age, and 47 ml/kg for adults.[L1099] At steady state, the volume of distribution of nonacog beta pegol is 64 ml/kg.[L1099] Nonacog beta pegol is not expected to accumulate in tissues.[A31502]

Klirens (Clearance) Mean clearance in children and adults ranged from 0.4 to 0.8 mL/hour/kg.[L43682]

Absorpsi

The mean area under the curve (AUC)_inf ranged from 46 to 91 IU*hours/mL in children and adults.^L43682 In preclinical studies, there was a reduced accumulation of systemic drug after multiple dosing.^L1103

Metabolisme

After being taken up by cells, the proteinic component of nonacog beta pegol is degraded by lysosomes or endosomes.^A31501 The PEG component of the drug is retained in the body 7.5 to 9 times longer than the original compound, as it is returned to circulation.^L1100

Rute Eliminasi

The 40 kDa PEG component of nonacog beta pegol is eliminated in urine and feces taking approximately 49 and 40% of the administered dose respectively.^A31502 The PEG part of the drug seems to be eliminated with a bi-phasic profile that was registered at 2-3 days and at 15-18 days.^L1103

Interaksi Obat

128 Data

Peginterferon alfa-2a	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Peginterferon alfa-2a.
Pegfilgrastim	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegfilgrastim.
Peginterferon alfa-2b	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Peginterferon alfa-2b.
Pegaspargase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegaspargase.
Pegademase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegademase.
Pegvisomant	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegvisomant.
Propylene glycol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Propylene glycol.
Heptaethylene glycol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Heptaethylene glycol.
Pegaptanib	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegaptanib.
Egaptivon pegol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Egaptivon pegol.
PEG-uricase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with PEG-uricase.
Peginterferon alfacon-1	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Peginterferon alfacon-1.
GlycoPEG-GCSF	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with GlycoPEG-GCSF.
Pegnivacogin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegnivacogin.
Pegpleranib	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegpleranib.
Pegsunercept	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegsunercept.
Polidocanol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Polidocanol.
Peginesatide	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Peginesatide.
Certolizumab pegol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Certolizumab pegol.
Methoxy polyethylene glycol-epoetin beta	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Methoxy polyethylene glycol-epoetin beta.
Peginterferon beta-1a	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Peginterferon beta-1a.
Pegloticase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegloticase.
Polyethylene glycol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Polyethylene glycol.
Antihemophilic factor (recombinant), PEGylated	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Antihemophilic factor (recombinant), PEGylated.
Insulin peglispro	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Insulin peglispro.
Eptacog alfa pegol (activated)	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Eptacog alfa pegol (activated).
Olaptesed Pegol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Olaptesed Pegol.
Abicipar Pegol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Abicipar Pegol.
Lexaptepid pegol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Lexaptepid pegol.
Cepeginterferon alfa-2B	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Cepeginterferon alfa-2B.
Pegvaliase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegvaliase.
Pegamotecan	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pegamotecan.
Lipegfilgrastim	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Lipegfilgrastim.
Damoctocog alfa pegol	The therapeutic efficacy of Damoctocog alfa pegol can be decreased when used in combination with Nonacog beta pegol.
Elapegademase	The therapeutic efficacy of Elapegademase can be decreased when used in combination with Nonacog beta pegol.
Aminocaproic acid	The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Nonacog beta pegol.
Alpha-1-proteinase inhibitor	Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Nonacog beta pegol.
Menadione	Menadione may increase the thrombogenic activities of Nonacog beta pegol.
Tranexamic acid	Tranexamic acid may increase the thrombogenic activities of Nonacog beta pegol.
Aprotinin	Aprotinin may increase the thrombogenic activities of Nonacog beta pegol.
Hydrogen peroxide	Hydrogen peroxide may increase the thrombogenic activities of Nonacog beta pegol.
Aminomethylbenzoic acid	Aminomethylbenzoic acid may increase the thrombogenic activities of Nonacog beta pegol.
Camostat	Camostat may increase the thrombogenic activities of Nonacog beta pegol.
Menadione bisulfite	Menadione bisulfite may increase the thrombogenic activities of Nonacog beta pegol.
Monteplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Monteplase.
Lepirudin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Lepirudin.
Bivalirudin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Bivalirudin.
Alteplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Alteplase.
Urokinase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Urokinase.
Reteplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Reteplase.
Anistreplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Anistreplase.
Tenecteplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Tenecteplase.
Abciximab	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Abciximab.
Drotrecogin alfa	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Drotrecogin alfa.
Streptokinase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Streptokinase.
Dicoumarol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Dicoumarol.
Argatroban	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Argatroban.
Ardeparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ardeparin.
Phenindione	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Phenindione.
Fondaparinux	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Fondaparinux.
Warfarin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Warfarin.
Pentosan polysulfate	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Pentosan polysulfate.
Phenprocoumon	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Phenprocoumon.
Dipyridamole	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Dipyridamole.
Heparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Heparin.
Enoxaparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Enoxaparin.
Epoprostenol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Epoprostenol.
Acenocoumarol	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Acenocoumarol.
4-hydroxycoumarin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with 4-hydroxycoumarin.
Coumarin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Coumarin.
Ximelagatran	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ximelagatran.
Desmoteplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Desmoteplase.
Defibrotide	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Defibrotide.
Ancrod	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ancrod.
Beraprost	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Beraprost.
Prasugrel	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Prasugrel.
Rivaroxaban	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Rivaroxaban.
Sulodexide	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Sulodexide.
Idraparinux	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Idraparinux.
Cangrelor	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Cangrelor.
Astaxanthin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Astaxanthin.
Apixaban	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Apixaban.
Otamixaban	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Otamixaban.
Amediplase	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Amediplase.
Dabigatran etexilate	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Dabigatran etexilate.
Danaparoid	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Danaparoid.
Dalteparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Dalteparin.
Tinzaparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Tinzaparin.
(R)-warfarin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with (R)-warfarin.
Ethyl biscoumacetate	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ethyl biscoumacetate.
Nadroparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Nadroparin.
Triflusal	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Triflusal.
Ticagrelor	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ticagrelor.
Ditazole	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Ditazole.
Vorapaxar	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Vorapaxar.
Edoxaban	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Edoxaban.
Sodium citrate	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Sodium citrate.
Dextran	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Dextran.
Bemiparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Bemiparin.
Parnaparin	The therapeutic efficacy of Nonacog beta pegol can be decreased when used in combination with Parnaparin.

Target Protein

Coagulation factor VII F7

Coagulation factor VIII F8

Coagulation factor X F10

Referensi & Sumber

Artikel (PubMed)

PMID: 22998153
Collins PW, Moss J, Knobe K, Groth A, Colberg T, Watson E: Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000.
PMID: 29124682
Syed YY: Nonacog Beta Pegol: A Review in Haemophilia B. Drugs. 2017 Dec;77(18):2003-2012. doi: 10.1007/s40265-017-0836-8.
PMID: 25535411
Palta S, Saroa R, Palta A: Overview of the coagulation system. Indian J Anaesth. 2014 Sep;58(5):515-23. doi: 10.4103/0019-5049.144643.
PMID: 24929223
Baumann A, Tuerck D, Prabhu S, Dickmann L, Sims J: Pharmacokinetics, metabolism and distribution of PEGs and PEGylated proteins: quo vadis? Drug Discov Today. 2014 Oct;19(10):1623-31. doi: 10.1016/j.drudis.2014.06.002. Epub 2014 Jun 11.
PMID: 27378188
Sternebring O, Christensen JK, Bjornsdottir I: Pharmacokinetics, tissue distribution, excretion, and metabolite profiling of PEGylated rFIX (nonacog beta pegol, N9-GP) in rats. Eur J Pharm Sci. 2016 Sep 20;92:163-72. doi: 10.1016/j.ejps.2016.06.025. Epub 2016 Jul 1.

Textbook

Konkle B., Huston H. and Fletcher S. (2017). Gene Reviews. University of Washington..

Link

Contoh Produk & Brand

Produk: 8 • International brands: 0

Produk

Rebinyn

Powder, for solution • 500 unit / vial • Intravenous • Canada • Approved
Rebinyn

Powder, for solution • 1000 unit / vial • Intravenous • Canada • Approved
Rebinyn

Powder, for solution • 2000 unit / vial • Intravenous • Canada • Approved
Rebinyn

Powder, for solution • 3000 unit / vial • Intravenous • Canada • Approved
Refixia

Injection, powder, for solution • 500 IU • Intravenous • EU • Approved
Refixia

Injection, powder, for solution • 1000 IU • Intravenous • EU • Approved
Refixia

Injection, powder, for solution • 2000 IU • Intravenous • EU • Approved
Refixia

Injection, powder, for solution • 3000 IU • Intravenous • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.