Peringatan Keamanan

There is limited clinical experience regarding the acute toxicity of inotuzumab ozogamicin. Overdoses may result in adverse reactions that are consistent with the reactions observed at the recommended therapeutic dose. In the event of an overdose, drug infusion should be temporarily interrupted, and patients should be monitored for liver and hematological toxicities. Re-initiation of the drug at the correct therapeutic dose should be considered when all toxicities have resolved.L938

Inotuzumab ozogamicin

DB05889

biotech approved investigational

Deskripsi

Inotuzumab ozogamicin is an antibody-drug conjugate consisting of a humanized IgG4 kappa CD22-targeting monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide.A20352 The antibody portion of the drug binds to CD22 receptors expressed on leukemic B cells and intracellularly releases N-acetyl-gamma-calicheamicin dimethylhydrazide, which produces cytotoxic effects.A20352

Inotuzumab ozogamicin was first approved by the European Commission in June 2017 for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).L938 A month later, inotuzumab ozogamicin was also approved by the FDA.L50542

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 patients with relapsed or refractory ALL, the terminal half-life was 12.3 days.[L938, L50542]
Volume Distribusi In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.[L938, L50542]
Klirens (Clearance) The pharmacokinetics of inotuzumab ozogamicin were well characterized by a 2-compartment model with linear and time-dependent clearance components. The clearance of inotuzumab ozogamicin at steady state is 0.0333 L/h in patients with relapsed or refractory ALL.[L938, L50542]

Absorpsi

Inotuzumab ozogamicin is intended to be administered in cycles that each run for 3 to 4 weeks.L938 The mean Cmax of inotuzumab ozogamicin was 308 ng/mL. The mean simulated total AUC per cycle was 100,000 ngxh/mL. In patients with relapsed or refractory ALL, steady-state drug concentration was achieved by Cycle 4. Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was predicted by Cycle 4.L50542

Metabolisme

In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolized via nonenzymatic reduction.L938, L50542 In humans, N acetyl-gamma-calicheamicin dimethylhydrazide serum levels were typically below the limit of quantitation of 50 pg/mL;L938, L50542 however, sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.L938 The antibody portion of the drug is thought to undergo proteolytic degradation into amino acids then recycled into other proteins.A20351

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

B-cell receptor CD22 CD22

Referensi & Sumber

Artikel (PubMed)
  • PMID: 17657218
    Dijoseph JF, Dougher MM, Armellino DC, Evans DY, Damle NK: Therapeutic potential of CD22-specific antibody-targeted chemotherapy using inotuzumab ozogamicin (CMC-544) for the treatment of acute lymphoblastic leukemia. Leukemia. 2007 Nov;21(11):2240-5. Epub 2007 Jul 26.
  • PMID: 25048520
    Han TH, Zhao B: Absorption, distribution, metabolism, and excretion considerations for the development of antibody-drug conjugates. Drug Metab Dispos. 2014 Nov;42(11):1914-20. doi: 10.1124/dmd.114.058586. Epub 2014 Jul 21.
  • PMID: 26425338
    Yilmaz M, Richard S, Jabbour E: The clinical potential of inotuzumab ozogamicin in relapsed and refractory acute lymphocytic leukemia. Ther Adv Hematol. 2015 Oct;6(5):253-61. doi: 10.1177/2040620715596715.
  • PMID: 27292104
    Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS: Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.
  • PMID: 28152223
    Thota S, Advani A: Inotuzumab ozogamicin in relapsed B-cell acute lymphoblastic leukemia. Eur J Haematol. 2017 May;98(5):425-434. doi: 10.1111/ejh.12862. Epub 2017 Mar 9.
  • PMID: 30087554
    Yurkiewicz IR, Muffly L, Liedtke M: Inotuzumab ozogamicin: a CD22 mAb-drug conjugate for adult relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Drug Des Devel Ther. 2018 Jul 24;12:2293-2300. doi: 10.2147/DDDT.S150317. eCollection 2018.

Contoh Produk & Brand

Produk: 3 • International brands: 0
Produk
  • Besponsa
    Injection, powder, lyophilized, for solution • 0.25 mg/1mL • Intravenous • US • Approved
  • Besponsa
    Powder, for solution • 0.9 mg / vial • Intravenous • Canada • Approved
  • Besponsa
    Injection, powder, for solution • 1 mg • Intravenous • EU • Approved

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