Peringatan Keamanan

There is limited information on overdose of ofatumumab. Ofatumumab may cause B-cell depletion in the fetus when administered in pregnant women.L12612

Ofatumumab

DB06650

biotech approved

Deskripsi

Ofatumumab is a novel anti-CD20 monoclonal antibody that targets B-cells. It is an IgG1? human monoclonal antibody produced from a recombinant murine cell line (NS0) via transgenic mouse and hybridoma technology.L12612 Ofatumumab works by recognizing antigens that are expressed on the tumour cells in certain cancers; however, the antigen is not tumour-specific and can also be found in normal B-cells.A6921 Ofatumumab was first approved by the FDA in 2009.L12771 It is used in the treatment of recurrent, progressive, or recurrent chronic lymphocytic leukemia (CLL) or CLL in treatment-naive patients in whom fludarabine-based therapy is considered inappropriate. Ofatumumab is used as monotherapy or in combination with other medications, depending on the patient profile and previous treatment history.L12612 Although it has a similar molecular mechanism of action as rituximab, another CD-20 monoclonal antibody used in the treatment of rheumatoid arthritis and B-cell non-Hodgkin's lymphoma, ofatumumab has a higher affinity towards CD20.A6921

Ofatumumab is available for intravenous administration and is marketed as Arzerra. In Phase III clinical trials consisting of subjects with relapsing forms of multiple sclerosis (RMS), subcutaneous administration of ofatumumab reduced the number of relapses and delayed disease progression. In February 2020, FDA and EMA approved Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of RMS in adults.L12753 The FDA subsequently approved ofatumumab for the treatment of RMS on August 20, 2020.L15581 The potential therapeutic use of ofatumumab in various lymphomas and rheumatoid arthritis has also been investigated.A193053

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 CLL, the mean half-life at steady state was 17.1 days.[L12612] Similarly, in patients given ofatumumab subcutaneously, the steady-state elimination half-life was estimated at 16 days.[L15581]
Volume Distribusi In patients with CLL, the mean volume of distribution at steady-state was 5.8 L.[L12612] Repeated subcutaneous dosing with 20 mg of ofatumumab resulted in a steady-state volume of distribution of 5.42 L.[L15581]
Klirens (Clearance) In patients with CLL, the mean clearance at steady-state was 11.6 mL/hour.[L12612] In patients administered ofatumumab subcutaneously in repeated 20 mg injections, the steady-state clearance following B-cell depletion was estimated to be 0.34 L/day.[L15581]

Absorpsi

In one study consisting of patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma, the Cmax was 94 ?g/mL and the Tmax was 7.3 hours following the first infusion of 300 mg ofatumumab.A193059 Following subcutaneous injection, ofatumumab is thought to be absorbed primarily into the lymphatic system. Subcutaneous dosing of 20 mg every four weeks resulted in a mean AUCtau of 483 ?g\*h/mL and a mean steady-state Cmax of 1.43 ?g/mL.L15581

Metabolisme

Like other monoclonal antibodies, ofatumumab is expected to undergo lysosomal degradation by the reticuloendothelial system and protein catabolism by a target?mediated disposition pathway.A40006

Rute Eliminasi

Ofatumumab undergoes elimination by a target-independent route and a target (B cell)-mediated route, with a dose-dependent clearance in the dose range of 100 to 2000 mg. As ofatumumab causes B-cell depletion, the clearance of ofatumumab mediated by B-cells is decreased substantially after subsequent drug infusions.L12612

Interaksi Obat

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

Target Protein

B-lymphocyte antigen CD20 MS4A1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 23226042
    Lin TS: Ofatumumab: a novel monoclonal anti-CD20 antibody. Pharmgenomics Pers Med. 2010;3:51-9. Epub 2010 May 10.
  • PMID: 17768100
    Glennie MJ, French RR, Cragg MS, Taylor RP: Mechanisms of killing by anti-CD20 monoclonal antibodies. Mol Immunol. 2007 Sep;44(16):3823-37.
  • PMID: 28653357
    Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29.
  • PMID: 20068404
    Zhang B: Ofatumumab. MAbs. 2009 Jul-Aug;1(4):326-31. doi: 10.4161/mabs.1.4.8895. Epub 2009 Jul 1.
  • PMID: 23456745
    Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Jewell RC, Katsura K, Hotta T: Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Jpn J Clin Oncol. 2013 May;43(5):466-75. doi: 10.1093/jjco/hyt022. Epub 2013 Feb 28.

Contoh Produk & Brand

Produk: 15 • International brands: 1
Produk
  • Arzerra
    Injection • 20 mg/1mL • Intravenous • US • Approved
  • Arzerra
    Injection, solution • 20 mg/1mL • Intravenous • US • Approved
  • Arzerra
    Injection, solution • 20 mg/1mL • Intravenous • US • Approved
  • Arzerra
    Injection, solution • 20 mg/1mL • Intravenous • US • Approved
  • Arzerra
    Solution • 100 mg / 5 mL • Intravenous • Canada • Approved
  • Arzerra
    Solution • 1000 mg / 50 mL • Intravenous • Canada • Approved
  • Arzerra
    Injection, solution, concentrate • 100 mg • Intravenous • EU
  • Arzerra
    Injection, solution, concentrate • 1000 mg • Intravenous • EU
Menampilkan 8 dari 15 produk.
International Brands
  • Kesimpta — Novartis

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