Peringatan Keamanan

The intravenous LD50 in monkeys is 200 mg/kg.L50487

Maximum tolerated dose of omalizumab has not been determined. Single intravenous doses up to 4000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects. If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms. Medical treatment should be sought and instituted appropriately.L50482

Omalizumab

DB00043

biotech approved investigational

Deskripsi

Omalizumab is a recombinant DNA-derived humanized monoclonal antibody directed against human immunoglobulin E (IgE).L50482 IgE promotes the release of inflammatory mediators from mast cells and basophils during allergic and inflammatory reactions. By binding to IgE and neutralizing it, omalizumab reduces free IgE levels and prevents IgE from binding to its receptors on immune cells.A39518

Omalizumab was first approved in the US in 2003 A263507 and in Europe in 2005.L50482 It is used to treat a range of immune and inflammatory conditions, including allergies, urticaria, and asthma.A263507

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) In asthma patients, the serum elimination half-life averaged 26 days. In CSU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days.[L50477]
Volume Distribusi In patients with asthma, the apparent volume of distribution was 78 ± 32 mL/kg following subcutaneous administration.[L50477]
Klirens (Clearance) In pharmacokinetic studies, the clearance of omalizumab involved IgG clearance as well as clearance by specific binding and complex formation with its target ligand, IgE. The apparent clearance averaged 2.4 ± 1.1 mL/kg/day in patients with asthma. The apparent clearance averaged 240 mL/day (corresponding to 3.0 mL/kg/day for an 80 kg patient).[L50482]

Absorpsi

After subcutaneous administration, omalizumab has an average absolute bioavailability of 62%. In adult and adolescent patients with asthma, omalizumab was absorbed slowly and the peak serum concentrations occurred after seven to eight days.L50477 The pharmacokinetics of omalizumab were linear at doses which were higher than 0.5 mg/kg. In patients with asthma, after several doses of omalizumab, areas under the serum concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those after one dose. After repeated dosing from 75mg-300 mg every 4 weeks, trough serum concentrations of omalizumab increased proportionally with the dose.L50477

Metabolisme

Omalizumab is degraded in the reticuloendothelial system and endothelial cells.A263507

Rute Eliminasi

Liver elimination of IgG includes degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG was also shown to be excreted in bile. In studies with mice and monkeys, omalizumab:IgE complexes were eliminated by interactions with Fc-gamma receptors within the RES at rates that were generally faster than IgG clearance.L50477

Interaksi Obat

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

Target Protein

Immunoglobulin heavy constant epsilon IGHE

Referensi & Sumber

Artikel (PubMed)
  • PMID: 25849503
    Jensen RK, Plum M, Tjerrild L, Jakob T, Spillner E, Andersen GR: Structure of the omalizumab Fab. Acta Crystallogr F Struct Biol Commun. 2015 Apr;71(Pt 4):419-26. doi: 10.1107/S2053230X15004100. Epub 2015 Mar 20.
  • PMID: 18774392
    Kaplan AP, Joseph K, Maykut RJ, Geba GP, Zeldin RK: Treatment of chronic autoimmune urticaria with omalizumab. J Allergy Clin Immunol. 2008 Sep;122(3):569-73. doi: 10.1016/j.jaci.2008.07.006.
  • PMID: 31424767
    Kumar C, Zito PM: Omalizumab. .
  • PMID: 32067933
    Okayama Y, Matsumoto H, Odajima H, Takahagi S, Hide M, Okubo K: Roles of omalizumab in various allergic diseases. Allergol Int. 2020 Apr;69(2):167-177. doi: 10.1016/j.alit.2020.01.004. Epub 2020 Feb 14.
  • PMID: 30400762
    Pelaia C, Calabrese C, Terracciano R, de Blasio F, Vatrella A, Pelaia G: Omalizumab, the first available antibody for biological treatment of severe asthma: more than a decade of real-life effectiveness. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618810192. doi: 10.1177/1753466618810192.

Contoh Produk & Brand

Produk: 44 • International brands: 0
Produk
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    Injection, solution • 75 mg • Subcutaneous • EU • Approved
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  • Xolair
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    Injection, solution • 150 mg/1.2mL • Subcutaneous • US • Approved
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