Peringatan Keamanan

There is no known antidote for isatuximab, nor does there appear to be any clinical experience with overdose.L12099 Symptoms of overdosage are likely to be consistent with isatuximab's adverse effect profile and may therefore include significant infusion-site reactions, gastrointestinal disturbances, and may increase the risk of infection. Treatment of overdose should involve careful monitoring of the patient and symptomatic and supportive measures as clinically indicated.L12099

Isatuximab

DB14811

biotech approved investigational

Deskripsi

Isatuximab (formerly SAR650984) is a humanized, IgG1-derived monoclonal antibody (mAb) produced from a Chinese hamster ovary (CHO) cell line.L12099,A191799 Structurally, isatuximab is comprised of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains.L12099 It is a cytolytic antibody targeted against CD38, a glycoprotein found on the surface of some immune cells that is highly expressed by malignant plasma cells in multiple myeloma.L12099 Along with daratumumab, another anti-CD38 mAb, isatuximab constitutes a novel treatment modality for patients with difficult-to-treat multiple myeloma.

Following three consecutive years on the yearly "Antibodies to watch" list published in "mAb", a peer-reviewed scientific journal dedicated to antibody research,A38676,A191826,A191829 isatuximab was granted Orphan Drug designation and approved on March 2nd, 2020, for the treatment of multiple myeloma.L12099,L12102 It is manufactured by Sanofi-Aventis U.S. under the brand name Sarclisa.L12102

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) -
Volume Distribusi The predicted volume of distribution of isatuximab is 8.13 L.[L12099]
Klirens (Clearance) Total clearance decreases with increasing dose and with multiple dosing.[L12099] At steady-state, it takes approximately 2 months to eliminate ?99% of isatuximab from plasma following the last dose.[L12099]

Absorpsi

When administered at the recommended dose and schedule, the steady-state Cmax and AUC were found to be 351 µg/mL and 72,600 ?g?h/mL, respectively.L12099 It takes approximately 8 weeks for isatuximab to reach steady-state. Over a dosage range of 1 mg/kg to 20 mg/kg given every 2 weeks AUC increases in a greater than dose-proportional manner, whereas over a dosage range of 5 mg/kg to 20 mg/kg every 4 weeks (followed by every 2 weeks) AUC was found to increase proportionately with dose. Steady-state AUC is lower in patients with increased body weight, but not to the extent that dose adjustments are required.L12099 Tmax ranges from approximately 2 to 5 hours, increasing with dose and with repeated dosing.A191802

Metabolisme

Isatuximab metabolism is likely to involve catabolism to smaller proteins and peptides.L12099

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 CD38

Referensi & Sumber

Artikel (PubMed)
  • PMID: 30692097
    Moreno L, Perez C, Zabaleta A, Manrique I, Alignani D, Ajona D, Blanco L, Lasa M, Maiso P, Rodriguez I, Garate S, Jelinek T, Segura V, Moreno C, Merino J, Rodriguez-Otero P, Panizo C, Prosper F, San-Miguel JF, Paiva B: The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma. Clin Cancer Res. 2019 May 15;25(10):3176-3187. doi: 10.1158/1078-0432.CCR-18-1597. Epub 2019 Jan 28.
  • PMID: 30546360
    Morandi F, Horenstein AL, Costa F, Giuliani N, Pistoia V, Malavasi F: CD38: A Target for Immunotherapeutic Approaches in Multiple Myeloma. Front Immunol. 2018 Nov 28;9:2722. doi: 10.3389/fimmu.2018.02722. eCollection 2018.
  • PMID: 30862646
    Mikhael J, Richardson P, Usmani SZ, Raje N, Bensinger W, Karanes C, Campana F, Kanagavel D, Dubin F, Liu Q, Semiond D, Anderson K: A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019 Jul 11;134(2):123-133. doi: 10.1182/blood-2019-02-895193. Epub 2019 Mar 12.
  • PMID: 31779273
    Martin TG, Corzo K, Chiron M, Velde HV, Abbadessa G, Campana F, Solanki M, Meng R, Lee H, Wiederschain D, Zhu C, Rak A, Anderson KC: Therapeutic Opportunities with Pharmacological Inhibition of CD38 with Isatuximab. Cells. 2019 Nov 26;8(12). pii: cells8121522. doi: 10.3390/cells8121522.
  • PMID: 30294326
    van de Donk NWCJ, Usmani SZ: CD38 Antibodies in Multiple Myeloma: Mechanisms of Action and Modes of Resistance. Front Immunol. 2018 Sep 20;9:2134. doi: 10.3389/fimmu.2018.02134. eCollection 2018.
  • PMID: 29300693
    Kaplon H, Reichert JM: Antibodies to watch in 2018. MAbs. 2018 Feb/Mar;10(2):183-203. doi: 10.1080/19420862.2018.1415671. Epub 2018 Jan 16.
  • PMID: 30516432
    Kaplon H, Reichert JM: Antibodies to watch in 2019. MAbs. 2019 Feb/Mar;11(2):219-238. doi: 10.1080/19420862.2018.1556465. Epub 2018 Dec 22.
  • PMID: 31847708
    Kaplon H, Muralidharan M, Schneider Z, Reichert JM: Antibodies to watch in 2020. MAbs. 2020 Jan-Dec;12(1):1703531. doi: 10.1080/19420862.2019.1703531.

Contoh Produk & Brand

Produk: 7 • International brands: 0
Produk
  • Sarclisa
    Injection, solution, concentrate • 100 mg/5mL • Intravenous • US • Approved
  • Sarclisa
    Injection, solution, concentrate • 500 mg/25mL • Intravenous • US • Approved
  • Sarclisa
    Injection, solution, concentrate • 20 mg/ml • Intravenous • EU • Approved
  • Sarclisa
    Injection, solution, concentrate • 20 mg/ml • Intravenous • EU • Approved
  • Sarclisa
    Injection, solution, concentrate • 20 mg/ml • Intravenous • EU • Approved
  • Sarclisa
    Solution • 100 mg / 5 mL • Intravenous • Canada • Approved
  • Sarclisa
    Solution • 500 mg / 25 mL • Intravenous • Canada • Approved

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