Peringatan Keamanan

Common adverse reactions reported in ?1% of subjects in the clinical studies were headache and nausea [FDA label.

In clinical trials, there are no data with Adynovate use in pregnant women to inform a drug- associated risk. Animal reproduction studies have not been conducted with Adynovate. It is unknown whether Adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adynovate should be given to a pregnant woman only if clearly needed ^{FDA label}.

Antihemophilic factor (recombinant), PEGylated

DB09329

biotech approved investigational

Deskripsi

Antihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product Adynovate ^{FDA label}.

Antihemophilic Factor (Recombinant), PEGylated, is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of approximately 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa) ^{FDA label}. It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events ^A32067, ^A32069, ^{FDA label}.

PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein. PEGylation decreases factor VIII clearance and allowing for an increased duration of drug circulation in the plasma ^L1529.

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) 14.69 ± 3.79h for adults aged ?18 years [FDA label] 13.43 ± 4.05 for children 12 to <18 years [FDA label]

Volume Distribusi At steady state: 0.56 ± 0.18 dL/Kg in children aged 12 to <18 years [FDA label] 0.43 ± 0.11 dL/kg in adults aged ?18 years [FDA label]

Klirens (Clearance) 2.27 ± 0.84 for adults ?18 years [FDA label] 3.87 ± 3.31 for children 12 to <18 years [FDA label]

Absorpsi

AUC0-Inf IU·h/dL: 1642 ± 752 in children aged 12 to <18 years ^{FDA label} 2264 ± 729 in adults ?18 years ^{FDA label}

Metabolisme

Data metabolisme tidak tersedia.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

843 Data

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

Target Protein

von Willebrand factor VWF

Referensi & Sumber

Artikel (PubMed)

PMID: 29359417
Dunn AL, Ahuja SP, Mullins ES: Real-world experience with use of Antihemophilic Factor (Recombinant), PEGylated for prophylaxis in severe haemophilia A. Haemophilia. 2018 Jan 23. doi: 10.1111/hae.13403.
PMID: 27382347
Wynn TT, Gumuscu B: Potential role of a new PEGylated recombinant factor VIII for hemophilia A. J Blood Med. 2016 Jun 20;7:121-8. doi: 10.2147/JBM.S82457. eCollection 2016.
PMID: 23398640
Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D: Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161.
PMID: 6424437
Chavin SI: Factor VIII: structure and function in blood clotting. Am J Hematol. 1984 Apr;16(3):297-306.
PMID: 15327526
Bovenschen N, van Dijk KW, Havekes LM, Mertens K, van Vlijmen BJ: Clearance of coagulation factor VIII in very low-density lipoprotein receptor knockout mice. Br J Haematol. 2004 Sep;126(5):722-5. doi: 10.1111/j.1365-2141.2004.05093.x.
PMID: 22282697
Coppola A, Di Capua M, Di Minno MN, Di Palo M, Marrone E, Ierano P, Arturo C, Tufano A, Cerbone AM: Treatment of hemophilia: a review of current advances and ongoing issues. J Blood Med. 2010;1:183-95. doi: 10.2147/JBM.S6885. Epub 2010 Aug 30.

Link

Contoh Produk & Brand

Produk: 12 • International brands: 0

Produk

Adynovate

Kit; Powder, for solution • 250 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 500 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 1000 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 2000 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 250 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 500 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 750 unit / vial • Intravenous • Canada • Approved
Adynovate

Kit; Powder, for solution • 750 unit / vial • Intravenous • Canada • Approved

Menampilkan 8 dari 12 produk.

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.