Peringatan Keamanan

Toxicity information regarding inebilizumab is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as severe infusion reactions, infections, and arthralgia. Symptomatic and supportive measures are recommended.

Inebilizumab

DB12530

biotech approved investigational

Deskripsi

Inappropriate growth of or self-directed antibody production by B-cells is the etiological underpinning of a variety of conditions, including the multiple sclerosis-like neurological condition neuromyelitis optica spectrum disorder (NMOSD).A214283, A214286 Inebilizumab is a humanized afucosylated monoclonal IgG1 antibody directed against the broadly expressed B-cell surface antigen CD19. Inebilizumab is cytolytic, resulting in B-cell depletion and offering therapeutic benefit to patients suffering from NMOSD. Compared to the anti-CD20 antibody rituximab, which is also used to treat NMOSD, inebilizumab has broader specificity.A214280, A214289, A214292, A214295, A214298, A214301

Inebilizumab was granted FDA approval on June 11, 2020, for the treatment of anti-aquaporin 4 positive NMOSD patients.L14315 Given its mechanism of action and good safety profile, it may prove useful in the treatment of other conditions linked to autoimmune antibody production or B-cell malignancies.A214280, A214295 On January 16, 2024, Iinebilizumab also received Health Canada approval for the same indication.L49861

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) Inebilizumab exhibits biphasic pharmacokinetics with a mean terminal half-life of 18 days.[L14315] The terminal half-life reported in phase I studies varied by dose but was typically close to 18 days, with a range of 6.8 to 18.7 days.[A214298, A214301]
Volume Distribusi Inebilizumab has an estimated central volume of distribution of 2.95L and a peripheral volume of distribution of 2.57L.[L14315] The steady-state volume of distribution in patients administered with a range of doses between 0.1 and 10.0 mg/kg ranged from 53.7 to 71.7 mL/kg.[A214301]
Klirens (Clearance) Inebilizumab has an estimated systemic clearance of 0.19 L/day.[L14315] In phase I studies, the reported clearance varied between 139-180 mL/day in one study,[A214298] and 3.5-6.2 mL/kg/day in another,[A214301] depending on the dose.

Absorpsi

Inebilizumab is given intravenously and hence is immediately exposed to the systemic circulation. The mean reported Cmax following second dose 300 mg administration was 108 ?g/mL, and the cumulative AUC following 26 weeks of treatment with two IV administrations was 2980 ?g\*d/mL.L14315 In a clinical trial investigating the use of inebilizumab in relapsing multiple sclerosis, the mean Cmax corresponding to 30, 100, and 600 mg of inebilizumab was 17.9, 43.1, and 248.0 ?g/mL and the AUC0-? was 440, 1150, and 6950 ?g\*d/mL.A214298 In another trial for patients with systemic sclerosis, the mean Cmax varied between 2.7 and 227.0 ?g/mL and the AUC0-? varied between 16.1 and 2890.0 ?g\*d/mL for doses between 0.1 and 10.0 mg/kg.A214301

Metabolisme

Inebilizumab is a monoclonal antibody and is hence likely degraded through proteolysis.L14315

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

692 Data
Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Inebilizumab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Inebilizumab.
Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Inebilizumab.
Estrone Estrone may increase the thrombogenic activities of Inebilizumab.
Estradiol Estradiol may increase the thrombogenic activities of Inebilizumab.
Dienestrol Dienestrol may increase the thrombogenic activities of Inebilizumab.
Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Inebilizumab.
Mestranol Mestranol may increase the thrombogenic activities of Inebilizumab.
Estriol Estriol may increase the thrombogenic activities of Inebilizumab.
Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Inebilizumab.
Quinestrol Quinestrol may increase the thrombogenic activities of Inebilizumab.
Hexestrol Hexestrol may increase the thrombogenic activities of Inebilizumab.
Tibolone Tibolone may increase the thrombogenic activities of Inebilizumab.
Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Inebilizumab.
Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Inebilizumab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Inebilizumab.
Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Inebilizumab.
Zeranol Zeranol may increase the thrombogenic activities of Inebilizumab.
Equol Equol may increase the thrombogenic activities of Inebilizumab.
Promestriene Promestriene may increase the thrombogenic activities of Inebilizumab.
Methallenestril Methallenestril may increase the thrombogenic activities of Inebilizumab.
Epimestrol Epimestrol may increase the thrombogenic activities of Inebilizumab.
Moxestrol Moxestrol may increase the thrombogenic activities of Inebilizumab.
Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Inebilizumab.
Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Inebilizumab.
Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Inebilizumab.
Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Inebilizumab.
Biochanin A Biochanin A may increase the thrombogenic activities of Inebilizumab.
Formononetin Formononetin may increase the thrombogenic activities of Inebilizumab.
Estetrol Estetrol may increase the thrombogenic activities of Inebilizumab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Inebilizumab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Inebilizumab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Inebilizumab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Inebilizumab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Inebilizumab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Inebilizumab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Inebilizumab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Inebilizumab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Inebilizumab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Inebilizumab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Inebilizumab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Inebilizumab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Inebilizumab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Inebilizumab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Inebilizumab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Inebilizumab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Inebilizumab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Inebilizumab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Inebilizumab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Inebilizumab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Inebilizumab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Inebilizumab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Inebilizumab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Inebilizumab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Inebilizumab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Inebilizumab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Inebilizumab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Inebilizumab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Inebilizumab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Inebilizumab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Inebilizumab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Inebilizumab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Inebilizumab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Inebilizumab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Inebilizumab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Inebilizumab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Inebilizumab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Inebilizumab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Inebilizumab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Inebilizumab.
Stamulumab The risk or severity of adverse effects can be increased when MYO-029 is combined with Inebilizumab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Inebilizumab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Inebilizumab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Inebilizumab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Inebilizumab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Inebilizumab.
TB-402 The risk or severity of adverse effects can be increased when TB-402 is combined with Inebilizumab.
Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Inebilizumab.
IMC-1C11 The risk or severity of adverse effects can be increased when IMC-1C11 is combined with Inebilizumab.
Eldelumab The risk or severity of adverse effects can be increased when Eldelumab is combined with Inebilizumab.
Lumiliximab The risk or severity of adverse effects can be increased when Lumiliximab is combined with Inebilizumab.
Ipilimumab The risk or severity of adverse effects can be increased when Ipilimumab is combined with Inebilizumab.
Nimotuzumab The risk or severity of adverse effects can be increased when Nimotuzumab is combined with Inebilizumab.
Clenoliximab The risk or severity of adverse effects can be increased when Clenoliximab is combined with Inebilizumab.
BIIB015 The risk or severity of adverse effects can be increased when BIIB015 is combined with Inebilizumab.
Sonepcizumab The risk or severity of adverse effects can be increased when Sonepcizumab is combined with Inebilizumab.
Motavizumab The risk or severity of adverse effects can be increased when Motavizumab is combined with Inebilizumab.
Elotuzumab The risk or severity of adverse effects can be increased when Elotuzumab is combined with Inebilizumab.
AVE9633 The risk or severity of adverse effects can be increased when AVE9633 is combined with Inebilizumab.
Carotuximab The risk or severity of adverse effects can be increased when Carotuximab is combined with Inebilizumab.
XmAb 2513 The risk or severity of adverse effects can be increased when XmAb 2513 is combined with Inebilizumab.
Coltuximab ravtansine The risk or severity of adverse effects can be increased when Coltuximab ravtansine is combined with Inebilizumab.
Lucatumumab The risk or severity of adverse effects can be increased when Lucatumumab is combined with Inebilizumab.
Pertuzumab The risk or severity of adverse effects can be increased when Pertuzumab is combined with Inebilizumab.
Siplizumab The risk or severity of adverse effects can be increased when Siplizumab is combined with Inebilizumab.
Apolizumab The risk or severity of adverse effects can be increased when Apolizumab is combined with Inebilizumab.
Sibrotuzumab The risk or severity of adverse effects can be increased when Sibrotuzumab is combined with Inebilizumab.
Bivatuzumab The risk or severity of adverse effects can be increased when Bivatuzumab is combined with Inebilizumab.
Lerdelimumab The risk or severity of adverse effects can be increased when Lerdelimumab is combined with Inebilizumab.
Lexatumumab The risk or severity of adverse effects can be increased when Lexatumumab is combined with Inebilizumab.

Target Protein

B-lymphocyte antigen CD19 CD19

Referensi & Sumber

Synthesis reference: Herbst R, Wang Y, Gallagher S, Mittereder N, Kuta E, Damschroder M, Woods R, Rowe DC, Cheng L, Cook K, Evans K, Sims GP, Pfarr DS, Bowen MA, Dall'Acqua W, Shlomchik M, Tedder TF, Kiener P, Jallal B, Wu H, Coyle AJ: B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody. J Pharmacol Exp Ther. 2010 Oct;335(1):213-22. doi: 10.1124/jpet.110.168062. Epub 2010 Jul 6.
Artikel (PubMed)
  • PMID: 20605905
    Herbst R, Wang Y, Gallagher S, Mittereder N, Kuta E, Damschroder M, Woods R, Rowe DC, Cheng L, Cook K, Evans K, Sims GP, Pfarr DS, Bowen MA, Dall'Acqua W, Shlomchik M, Tedder TF, Kiener P, Jallal B, Wu H, Coyle AJ: B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody. J Pharmacol Exp Ther. 2010 Oct;335(1):213-22. doi: 10.1124/jpet.110.168062. Epub 2010 Jul 6.
  • PMID: 28385199
    Weinshenker BG, Wingerchuk DM: Neuromyelitis Spectrum Disorders. Mayo Clin Proc. 2017 Apr;92(4):663-679. doi: 10.1016/j.mayocp.2016.12.014.
  • PMID: 30530071
    Wu Y, Zhong L, Geng J: Neuromyelitis optica spectrum disorder: Pathogenesis, treatment, and experimental models. Mult Scler Relat Disord. 2019 Jan;27:412-418. doi: 10.1016/j.msard.2018.12.002. Epub 2018 Dec 3.
  • PMID: 27163209
    Gallagher S, Turman S, Yusuf I, Akhgar A, Wu Y, Roskos LK, Herbst R, Wang Y: Pharmacological profile of MEDI-551, a novel anti-CD19 antibody, in human CD19 transgenic mice. Int Immunopharmacol. 2016 Jul;36:205-212. doi: 10.1016/j.intimp.2016.04.035. Epub 2016 May 7.
  • PMID: 26606525
    Gallagher S, Yusuf I, McCaughtry TM, Turman S, Sun H, Kolbeck R, Herbst R, Wang Y: MEDI-551 Treatment Effectively Depletes B Cells and Reduces Serum Titers of Autoantibodies in Mice Transgenic for Sle1 and Human CD19. Arthritis Rheumatol. 2016 Apr;68(4):965-76. doi: 10.1002/art.39503.
  • PMID: 31495497
    Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E: Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5.
  • PMID: 29143550
    Agius MA, Klodowska-Duda G, Maciejowski M, Potemkowski A, Li J, Patra K, Wesley J, Madani S, Barron G, Katz E, Flor A: Safety and tolerability of inebilizumab (MEDI-551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study. Mult Scler. 2019 Feb;25(2):235-245. doi: 10.1177/1352458517740641. Epub 2017 Nov 16.
  • PMID: 27267753
    Schiopu E, Chatterjee S, Hsu V, Flor A, Cimbora D, Patra K, Yao W, Li J, Streicher K, McKeever K, White B, Katz E, Drappa J, Sweeny S, Herbst R: Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. Arthritis Res Ther. 2016 Jun 7;18(1):131. doi: 10.1186/s13075-016-1021-2.

Contoh Produk & Brand

Produk: 4 • International brands: 0
Produk
  • Uplizna
    Solution • 10 mg / mL • Intravenous • Canada • Approved
  • Uplizna
    Injection • 10 mg/1mL • Intravenous • US • Approved
  • Uplizna
    Injection, solution, concentrate • 100 mg • Intravenous • EU • Approved
  • Uplizna
    Injection • 10 mg/1mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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