Peringatan Keamanan

The intravenous LD50 was >125 mg/kg in mice.L46986 There is no clinical experience with the overdosage of bezlotoxumab.L46976 In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.L47191 In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.L46976

Bezlotoxumab

DB13140

biotech approved investigational

Deskripsi

Bezlotoxumab is a fully humanized ImmunoglobulinG1 (IgG1) kappa monoclonal antibody that binds to Clostridium difficile toxin B and neutralizes its effects.L46976 First approved by the FDA on October 21, 2016,A260106 bezlotoxumab is used to reduce the recurrence of C. difficile infection.L46976 On November 22, 2016, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of a marketing authorization.A260106 The drug was granted full approval by the EMA on January 18, 2017.L47191

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) Based on a population pharmacokinetic analysis, the geometric mean (%CV) elimination half-life is approximately 19 days (28%).[L360]
Volume Distribusi Based on a population pharmacokinetic analysis, the geometric mean (%CV) volume of distribution was 7.33 L (16%).[L360]
Klirens (Clearance) Based on a population pharmacokinetic analysis, the geometric mean (%CV) clearance of bezlotoxumab was 0.317 L/day (41%). The clearance of bezlotoxumab increased with increasing body weight: the resulting exposure differences are adequately addressed by the administration of a weight-based dose.[L360]

Absorpsi

After a single intravenous dose of 10 mg/kg bezlotoxumab, geometric mean AUC0-? and Cmax were 53000 mcg x h/mL and 185 mcg/mL, respectively, in patients with CDI.L46976

Metabolisme

Bezlotoxumab undergoes protein catabolism.A260106, L360

Rute Eliminasi

Bezlotoxumab is mainly eliminated by catabolism.L360

Interaksi Obat

373 Data
Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Bezlotoxumab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Bezlotoxumab.
Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Bezlotoxumab.
Estrone Estrone may increase the thrombogenic activities of Bezlotoxumab.
Estradiol Estradiol may increase the thrombogenic activities of Bezlotoxumab.
Dienestrol Dienestrol may increase the thrombogenic activities of Bezlotoxumab.
Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Bezlotoxumab.
Mestranol Mestranol may increase the thrombogenic activities of Bezlotoxumab.
Estriol Estriol may increase the thrombogenic activities of Bezlotoxumab.
Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Bezlotoxumab.
Quinestrol Quinestrol may increase the thrombogenic activities of Bezlotoxumab.
Hexestrol Hexestrol may increase the thrombogenic activities of Bezlotoxumab.
Tibolone Tibolone may increase the thrombogenic activities of Bezlotoxumab.
Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Bezlotoxumab.
Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Bezlotoxumab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Bezlotoxumab.
Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Bezlotoxumab.
Zeranol Zeranol may increase the thrombogenic activities of Bezlotoxumab.
Equol Equol may increase the thrombogenic activities of Bezlotoxumab.
Promestriene Promestriene may increase the thrombogenic activities of Bezlotoxumab.
Methallenestril Methallenestril may increase the thrombogenic activities of Bezlotoxumab.
Epimestrol Epimestrol may increase the thrombogenic activities of Bezlotoxumab.
Moxestrol Moxestrol may increase the thrombogenic activities of Bezlotoxumab.
Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Bezlotoxumab.
Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Bezlotoxumab.
Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Bezlotoxumab.
Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Bezlotoxumab.
Biochanin A Biochanin A may increase the thrombogenic activities of Bezlotoxumab.
Formononetin Formononetin may increase the thrombogenic activities of Bezlotoxumab.
Estetrol Estetrol may increase the thrombogenic activities of Bezlotoxumab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Bezlotoxumab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Bezlotoxumab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Bezlotoxumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Bezlotoxumab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Bezlotoxumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Bezlotoxumab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Bezlotoxumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Bezlotoxumab.
Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Bezlotoxumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Bezlotoxumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Bezlotoxumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Bezlotoxumab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Bezlotoxumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Bezlotoxumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Bezlotoxumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Bezlotoxumab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Bezlotoxumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Bezlotoxumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Bezlotoxumab.
Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Bezlotoxumab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Bezlotoxumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Bezlotoxumab.
Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Bezlotoxumab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Bezlotoxumab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Bezlotoxumab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Bezlotoxumab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Bezlotoxumab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Bezlotoxumab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Bezlotoxumab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Bezlotoxumab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Bezlotoxumab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Bezlotoxumab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Bezlotoxumab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Bezlotoxumab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Bezlotoxumab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Bezlotoxumab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Bezlotoxumab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Bezlotoxumab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Bezlotoxumab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Bezlotoxumab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Bezlotoxumab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Bezlotoxumab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Bezlotoxumab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Bezlotoxumab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Bezlotoxumab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Bezlotoxumab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Bezlotoxumab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Bezlotoxumab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Bezlotoxumab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Bezlotoxumab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Bezlotoxumab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Bezlotoxumab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Bezlotoxumab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Bezlotoxumab.
Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Bezlotoxumab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Bezlotoxumab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Bezlotoxumab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Bezlotoxumab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Bezlotoxumab.
Stamulumab The risk or severity of adverse effects can be increased when MYO-029 is combined with Bezlotoxumab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Bezlotoxumab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Bezlotoxumab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Bezlotoxumab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Bezlotoxumab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Bezlotoxumab.
TB-402 The risk or severity of adverse effects can be increased when TB-402 is combined with Bezlotoxumab.
Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Bezlotoxumab.
IMC-1C11 The risk or severity of adverse effects can be increased when IMC-1C11 is combined with Bezlotoxumab.
Eldelumab The risk or severity of adverse effects can be increased when Eldelumab is combined with Bezlotoxumab.
Lumiliximab The risk or severity of adverse effects can be increased when Lumiliximab is combined with Bezlotoxumab.

Target Protein

Toxin B toxB

Referensi & Sumber

Artikel (PubMed)
  • PMID: 24821719
    Orth P, Xiao L, Hernandez LD, Reichert P, Sheth PR, Beaumont M, Yang X, Murgolo N, Ermakov G, DiNunzio E, Racine F, Karczewski J, Secore S, Ingram RN, Mayhood T, Strickland C, Therien AG: Mechanism of action and epitopes of Clostridium difficile toxin B-neutralizing antibody bezlotoxumab revealed by X-ray crystallography. J Biol Chem. 2014 Jun 27;289(26):18008-21. doi: 10.1074/jbc.M114.560748. Epub 2014 May 12.
  • PMID: 27905086
    Markham A: Bezlotoxumab: First Global Approval. Drugs. 2016 Dec;76(18):1793-1798. doi: 10.1007/s40265-016-0673-1.
  • PMID: 36120235
    Thandavaram A, Channar A, Purohit A, Shrestha B, Patel D, Shah H, Hanna K, Kaur H, Alazzeh MS, Mohammed L: The Efficacy of Bezlotoxumab in the Prevention of Recurrent Clostridium difficile: A Systematic Review. Cureus. 2022 Aug 13;14(8):e27979. doi: 10.7759/cureus.27979. eCollection 2022 Aug.
  • PMID: 28636484
    Villafuerte Galvez JA, Kelly CP: Bezlotoxumab: anti-toxin B monoclonal antibody to prevent recurrence of Clostridium difficile infection. Expert Rev Gastroenterol Hepatol. 2017 Jul;11(7):611-622. doi: 10.1080/17474124.2017.1344551. Epub 2017 Jun 26.

Contoh Produk & Brand

Produk: 3 • International brands: 0
Produk
  • Zinplava
    Injection, solution, concentrate • 25 mg/ml • Intravenous • EU • Approved
  • Zinplava
    Injection, solution • 25 mg/1mL • Intravenous • US • Approved
  • Zinplava
    Injection, solution, concentrate • 25 mg/ml • Intravenous • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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