Peringatan Keamanan

There was no experience with overdosage of glofitamab in clinical trials.L45698

Glofitamab

DB16371

biotech approved investigational

Deskripsi

Glofitamab is a full-length bispecific monoclonal antibody with affinity for both CD20 and CD3 surface antigens found on B- and T-cells, respectively. It has a 2:1 configuration, with bivalency towards CD20 and monovalency towards CD3, and works by recruiting T-cells directly to the surface of cancerous B-cells.L45698,A258488

Glofitamab was approved by Health Canada in March 2023 for the treatment of certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), becoming the first CD20/CD3 bispecific monoclonal antibody approved for DLBCL.L45768 The most common type of non-Hodgkin lymphoma,L45763 DLBCL is relatively sensitive to chemotherapy and generally responsive to first-line treatment regimens like CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)L45763 - despite this, as many as 40% of patients will experience relapsed or refractory disease.L45768,A258433 In the context of relapsed or refractory DLBCL, glofitamab provides an alternative treatment option for patients having failed other systemic therapies or for whom targeted therapies - such as CAR-T cell therapy - are inappropriate.

In June 2023, the FDA approved the use of glofitamab for the treatment of patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy under accelerated approval based on response rate and durability of response.L47047,L47052

Glofitamab was granted conditional marketing authorization in July 2023 by the EMA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval is based on the positive results obtained from the phase I/II NP30179 study, where 35.2% of study participants achieved a complete response.L47451

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The transition from non-linear to linear clearance phase was estimated to take approximately 1.56 days, after which the effective linear half-life of glofitamab is approximately 6.54 days.[L45698]
Volume Distribusi Following intravenous administration, population pharmacokinetic modeling estimated the central and peripheral volumes of distribution to be 3.33 L and 2.18 L, respectively, with an intercompartmental clearance of 0.674 L/day.[L45698]
Klirens (Clearance) Glofitamab's serum concentration-time data are best described by a two-compartment model and both time-independent and time-varying clearance parameters. Population pharmacokinetic modeling estimated a time-independent clearance parameter of 0.602 L/day, and an initial time-varying clearance parameter of 0.396 L/day.[L45698]

Absorpsi

According to population pharmacokinetic analysis, the geometric mean Cmax of glofitamab on day 1 after the first infusion of 2.5 mg was 0.674 µg/mL. At the end of cycle 2 - following the step-up dosing to a final dose of 30 mg - the geometric mean Cmax was estimated via population pharmacokinetic modeling to be 7.67 µg/mL.L45698 Non-compartmental analysis following a single dose of 10 mg showed a geometric mean Cmax of 2.34 µg/mL, Tmax of 8.05, and AUCinf of 244 hr*µg/mL.L45698

Metabolisme

The metabolism of glofitamab has not been directly studied. As with other therapeutic antibodies, it is likely metabolized primarily via catabolism to smaller peptides and amino acids.L45698

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

1337 Data
Diethylstilbestrol The serum concentration of Diethylstilbestrol can be increased when it is combined with Glofitamab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Glofitamab.
Conjugated estrogens The serum concentration of Conjugated estrogens can be increased when it is combined with Glofitamab.
Estrone The serum concentration of Estrone can be increased when it is combined with Glofitamab.
Estradiol The serum concentration of Estradiol can be increased when it is combined with Glofitamab.
Dienestrol Dienestrol may increase the thrombogenic activities of Glofitamab.
Ethinylestradiol The serum concentration of Ethinylestradiol can be increased when it is combined with Glofitamab.
Mestranol The serum concentration of Mestranol can be increased when it is combined with Glofitamab.
Estriol Estriol may increase the thrombogenic activities of Glofitamab.
Estrone sulfate The serum concentration of Estrone sulfate can be increased when it is combined with Glofitamab.
Quinestrol Quinestrol may increase the thrombogenic activities of Glofitamab.
Hexestrol Hexestrol may increase the thrombogenic activities of Glofitamab.
Tibolone Tibolone may increase the thrombogenic activities of Glofitamab.
Synthetic Conjugated Estrogens, A The serum concentration of Synthetic Conjugated Estrogens, A can be increased when it is combined with Glofitamab.
Synthetic Conjugated Estrogens, B The serum concentration of Synthetic Conjugated Estrogens, B can be increased when it is combined with Glofitamab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Glofitamab.
Esterified estrogens The serum concentration of Esterified estrogens can be increased when it is combined with Glofitamab.
Zeranol Zeranol may increase the thrombogenic activities of Glofitamab.
Equol Equol may increase the thrombogenic activities of Glofitamab.
Estetrol The serum concentration of Estetrol can be increased when it is combined with Glofitamab.
Promestriene Promestriene may increase the thrombogenic activities of Glofitamab.
Methallenestril Methallenestril may increase the thrombogenic activities of Glofitamab.
Epimestrol Epimestrol may increase the thrombogenic activities of Glofitamab.
Moxestrol Moxestrol may increase the thrombogenic activities of Glofitamab.
Estradiol acetate The serum concentration of Estradiol acetate can be increased when it is combined with Glofitamab.
Estradiol benzoate The serum concentration of Estradiol benzoate can be increased when it is combined with Glofitamab.
Estradiol cypionate The serum concentration of Estradiol cypionate can be increased when it is combined with Glofitamab.
Estradiol valerate The serum concentration of Estradiol valerate can be increased when it is combined with Glofitamab.
Biochanin A Biochanin A may increase the thrombogenic activities of Glofitamab.
Formononetin Formononetin may increase the thrombogenic activities of Glofitamab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Glofitamab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Glofitamab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Glofitamab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Glofitamab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Glofitamab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Glofitamab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Glofitamab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Glofitamab.
Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Glofitamab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Glofitamab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Glofitamab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Glofitamab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Glofitamab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Glofitamab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Glofitamab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Glofitamab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Glofitamab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Glofitamab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Glofitamab.
Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Glofitamab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Glofitamab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Glofitamab.
Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Glofitamab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Glofitamab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Glofitamab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Glofitamab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Glofitamab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Glofitamab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Glofitamab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Glofitamab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Glofitamab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Glofitamab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Glofitamab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Glofitamab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Glofitamab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Glofitamab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Glofitamab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Glofitamab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Glofitamab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Glofitamab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Glofitamab.
Hepatitis B immune globulin The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Glofitamab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Glofitamab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Glofitamab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Glofitamab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Glofitamab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Glofitamab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Glofitamab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Glofitamab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Glofitamab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Glofitamab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Glofitamab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Glofitamab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Glofitamab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Glofitamab.
Trastuzumab emtansine The serum concentration of Trastuzumab emtansine can be increased when it is combined with Glofitamab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Glofitamab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Glofitamab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Glofitamab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Glofitamab.
Stamulumab The risk or severity of adverse effects can be increased when Stamulumab is combined with Glofitamab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Glofitamab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Glofitamab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Glofitamab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Glofitamab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Glofitamab.
TB-402 The risk or severity of adverse effects can be increased when TB-402 is combined with Glofitamab.
Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Glofitamab.
IMC-1C11 The risk or severity of adverse effects can be increased when IMC-1C11 is combined with Glofitamab.
Eldelumab The risk or severity of adverse effects can be increased when Eldelumab is combined with Glofitamab.

Target Protein

B-lymphocyte antigen CD20 MS4A1
T-cell surface glycoprotein CD3 CD3D

Contoh Produk & Brand

Produk: 6 • International brands: 0
Produk
  • Columvi
    Solution • 10 mg / 10 mL • Intravenous • Canada • Approved
  • Columvi
    Solution • 2.5 mg / 2.5 mL • Intravenous • Canada • Approved
  • Columvi
    Injection, solution, concentrate • 2.5 mg • Intravenous • EU • Approved
  • Columvi
    Injection, solution, concentrate • 10 mg • Intravenous • EU • Approved
  • Columvi
    Concentrate • 10 mg/10mL • Intravenous • US • Approved
  • Columvi
    Solution, concentrate • 2.5 mg/2.5mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

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