Peringatan Keamanan

In case of a mosunetuzumab overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.L42230 Patients experiencing an overdose are at an increased risk of severe adverse effects such as cytokine release syndrome (CRS), febrile neutropenia, neutropenia and pneumonia.A249320,L42230

Preclinical single- and repeat-dose toxicity studies of up to 26 weeks in duration found that transient CRS was developed mostly after the first dose of mosunetuzumab. Findings suggest that this effect is pharmacologically-mediated and reversible.L42230 The effect of mosunetuzumab on male and female reproductive organs was evaluated in sexually mature cynomolgus monkeys given an intravenous infusion dose equivalent to the one recommended in patients. Up to 26 weeks, mosunetuzumab did not have an effect on male or female reproductive organs.L42230 Preclinical studies evaluating the effect of mosunetuzumab on developmental toxicity have not been conducted. Due to the low placental transfer of antibodies during the first trimester, mosunetuzumab is not expected to have a teratogenic effect. However, it can lead to a higher risk of opportunistic infections, which may cause fetal loss.L42230

Mosunetuzumab

DB15434

biotech approved investigational

Deskripsi

Mosunetuzumab is a humanized anti-CD20/CD3 bispecific antibody.L42230 It can recognize and bind two different targets simultaneously, CD20 on cancer B-cells and CD3 on T-cells, allowing it to redirect T-cell cytotoxic activity to cancer cells.A249320 The standard of care for patients with B-cell lymphoma includes an anti-CD20 monoclonal antibody, such as rituximab, in combination with chemotherapy. However, patients with certain types of B-cell lymphoma, such as follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or aggressive B-cell lymphoma, have a high probability of relapse or recurrence after treatment.A249320,A249390 Mosunetuzumab has the potential to circumvent resistance to rituximab in patients with follicular lymphoma,A249320,L42230 and unlike CAR-T therapies such as axicabtagene ciloleucel and tisagenlecleucel, it is an “off-the-shelf” alternative, readily available to patients.L42245 In June 2022, the European Medicines Agency approved mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) FL who have received at least two prior systemic therapies.L42245 In January 2023, the use of mosunetuzumab was approved by the FDA under accelerated approval based on response rate.L44562

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) Mosunetuzumab has a terminal half-life of 16.1 days,[L42230,L44562] and an apparent half-life between 6 and 11 days.[A249320]
Volume Distribusi The estimated central volume of distribution for mosunetuzumab administered via intravenous infusion is 5.49 L.[L42230,L44562]
Klirens (Clearance) The mean steady-state plateau clearance (CL<sub>ss</sub>) of mosunetuzumab is 1.08 L/day, and its baseline clearance (CL<sub>base</sub>) is 0.584 L/day.[L42230,L44562]

Absorpsi

Between 0.05 and 60 mg, mosunetuzumab follows a dose-proportional pharmacokinetic profile. The population pharmacokinetics of intravenous mosunetuzumab are described with a two-compartment pharmacokinetic model with time-dependent clearance.L42230 After two cycles of mosunetuzumab (42 days, given by intravenous infusion), patients reached a Cmax of 17.9 µg/mL at the end of dose of Cycle 2 Day 1. The average AUC of two cycles of mosunetuzumab was 126 µg?day/mL.L42230 In patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with mosunetuzumab, serum concentration reached the Cmax at the end of the intravenous infusion and declined in a bi-exponential fashion.L42230 The steady-state values of mosunetuzumab were reached at cycle 4 (63 ? 84 days). Steady-state AUC and Cmax were 52.9 day??g/mL and 7.02 ?g/mL, respectively.L44562 Mosunetuzumab is expected to have a bioavailability close to 100% when given intravenously. In clinical trials, mosunetuzumab administered subcutaneously had a slow absorption rate and high bioavailability (>75%).A249335 The pharmacokinetics of mosunetuzumab was similar in Asian and non-Asian subjects. Compared to males, the steady-state clearance of mosunetuzumab in females is marginally lower (approximately 13%), and dose adjustment based on gender is not required.L42230

Metabolisme

Mosunetuzumab is a protein therapeutic; it is expected to be degraded into small peptides and amino acids via catabolic pathways.L42230

Rute Eliminasi

Since mosunetuzumab is an immunoglobulin G (IgG) antibody, it is expected to be mainly eliminated via intracellular catabolism. Hepatic or renal impairment is not expected to influence the elimination of mosunetuzumab.L42230

Interaksi Obat

909 Data
Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Mosunetuzumab.
Etanercept The risk or severity of adverse effects can be increased when Etanercept is combined with Mosunetuzumab.
Peginterferon alfa-2a The risk or severity of adverse effects can be increased when Peginterferon alfa-2a is combined with Mosunetuzumab.
Interferon alfa-n1 The risk or severity of adverse effects can be increased when Interferon alfa-n1 is combined with Mosunetuzumab.
Interferon alfa-n3 The risk or severity of adverse effects can be increased when Interferon alfa-n3 is combined with Mosunetuzumab.
Peginterferon alfa-2b The risk or severity of adverse effects can be increased when Peginterferon alfa-2b is combined with Mosunetuzumab.
Anakinra The risk or severity of adverse effects can be increased when Anakinra is combined with Mosunetuzumab.
Interferon gamma-1b The risk or severity of adverse effects can be increased when Interferon gamma-1b is combined with Mosunetuzumab.
Interferon alfa-2a The risk or severity of adverse effects can be increased when Interferon alfa-2a is combined with Mosunetuzumab.
Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Mosunetuzumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Mosunetuzumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Mosunetuzumab.
Pegaspargase The risk or severity of adverse effects can be increased when Pegaspargase is combined with Mosunetuzumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Mosunetuzumab.
Interferon beta-1b The risk or severity of adverse effects can be increased when Interferon beta-1b is combined with Mosunetuzumab.
Interferon alfacon-1 The risk or severity of adverse effects can be increased when Interferon alfacon-1 is combined with Mosunetuzumab.
Trastuzumab The risk or severity of neutropenia can be increased when Trastuzumab is combined with Mosunetuzumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Mosunetuzumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Mosunetuzumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Mosunetuzumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Mosunetuzumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Mosunetuzumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Mosunetuzumab.
Cyclosporine Mosunetuzumab may increase the immunosuppressive activities of Cyclosporine.
Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Mosunetuzumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Mosunetuzumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Mosunetuzumab.
Interferon alfa-2b The risk or severity of adverse effects can be increased when Interferon alfa-2b is combined with Mosunetuzumab.
Natalizumab The risk or severity of immunosuppression can be increased when Mosunetuzumab is combined with Natalizumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Mosunetuzumab.
Phenylalanine The risk or severity of adverse effects can be increased when Phenylalanine is combined with Mosunetuzumab.
Flunisolide The risk or severity of adverse effects can be increased when Flunisolide is combined with Mosunetuzumab.
Bortezomib The metabolism of Bortezomib can be decreased when combined with Mosunetuzumab.
Cladribine Mosunetuzumab may increase the immunosuppressive activities of Cladribine.
Carmustine The risk or severity of adverse effects can be increased when Carmustine is combined with Mosunetuzumab.
Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Mosunetuzumab.
Bleomycin The risk or severity of adverse effects can be increased when Bleomycin is combined with Mosunetuzumab.
Chlorambucil The risk or severity of adverse effects can be increased when Chlorambucil is combined with Mosunetuzumab.
Raltitrexed The risk or severity of adverse effects can be increased when Raltitrexed is combined with Mosunetuzumab.
Mitomycin The risk or severity of adverse effects can be increased when Mitomycin is combined with Mosunetuzumab.
Bexarotene The risk or severity of adverse effects can be increased when Bexarotene is combined with Mosunetuzumab.
Vindesine The metabolism of Vindesine can be decreased when combined with Mosunetuzumab.
Floxuridine The risk or severity of adverse effects can be increased when Floxuridine is combined with Mosunetuzumab.
Fluorometholone The risk or severity of adverse effects can be increased when Fluorometholone is combined with Mosunetuzumab.
Indomethacin The risk or severity of adverse effects can be increased when Indomethacin is combined with Mosunetuzumab.
Tioguanine The risk or severity of adverse effects can be increased when Tioguanine is combined with Mosunetuzumab.
Vinorelbine The metabolism of Vinorelbine can be decreased when combined with Mosunetuzumab.
Dexrazoxane The risk or severity of adverse effects can be increased when Dexrazoxane is combined with Mosunetuzumab.
Beclomethasone dipropionate The risk or severity of adverse effects can be increased when Beclomethasone dipropionate is combined with Mosunetuzumab.
Sorafenib The metabolism of Sorafenib can be decreased when combined with Mosunetuzumab.
Streptozocin The risk or severity of adverse effects can be increased when Streptozocin is combined with Mosunetuzumab.
Trifluridine The risk or severity of adverse effects can be increased when Trifluridine is combined with Mosunetuzumab.
Gemcitabine The risk or severity of adverse effects can be increased when Gemcitabine is combined with Mosunetuzumab.
Betamethasone The risk or severity of adverse effects can be increased when Betamethasone is combined with Mosunetuzumab.
Teniposide The metabolism of Teniposide can be decreased when combined with Mosunetuzumab.
Epirubicin The risk or severity of adverse effects can be increased when Epirubicin is combined with Mosunetuzumab.
Chloramphenicol The risk or severity of adverse effects can be increased when Chloramphenicol is combined with Mosunetuzumab.
Lenalidomide The risk or severity of adverse effects can be increased when Lenalidomide is combined with Mosunetuzumab.
Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Mosunetuzumab.
Zidovudine The risk or severity of adverse effects can be increased when Zidovudine is combined with Mosunetuzumab.
Cisplatin The risk or severity of adverse effects can be increased when Cisplatin is combined with Mosunetuzumab.
Oxaliplatin The risk or severity of adverse effects can be increased when Oxaliplatin is combined with Mosunetuzumab.
Cyclophosphamide The metabolism of Cyclophosphamide can be decreased when combined with Mosunetuzumab.
Vincristine The metabolism of Vincristine can be decreased when combined with Mosunetuzumab.
Fluorouracil The metabolism of Fluorouracil can be decreased when combined with Mosunetuzumab.
Desoximetasone The risk or severity of adverse effects can be increased when Desoximetasone is combined with Mosunetuzumab.
Propylthiouracil The risk or severity of adverse effects can be increased when Propylthiouracil is combined with Mosunetuzumab.
Pentostatin The risk or severity of adverse effects can be increased when Pentostatin is combined with Mosunetuzumab.
Methotrexate The metabolism of Methotrexate can be decreased when combined with Mosunetuzumab.
Carbamazepine The metabolism of Carbamazepine can be decreased when combined with Mosunetuzumab.
Vinblastine The metabolism of Vinblastine can be decreased when combined with Mosunetuzumab.
Fluticasone propionate The risk or severity of adverse effects can be increased when Fluticasone propionate is combined with Mosunetuzumab.
Fluocinolone acetonide The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Mosunetuzumab.
Linezolid The risk or severity of adverse effects can be increased when Linezolid is combined with Mosunetuzumab.
Imatinib The risk or severity of adverse effects can be increased when Imatinib is combined with Mosunetuzumab.
Triamcinolone The risk or severity of adverse effects can be increased when Triamcinolone is combined with Mosunetuzumab.
Clofarabine The risk or severity of adverse effects can be increased when Clofarabine is combined with Mosunetuzumab.
Prednisone The risk or severity of adverse effects can be increased when Prednisone is combined with Mosunetuzumab.
Pemetrexed The risk or severity of adverse effects can be increased when Pemetrexed is combined with Mosunetuzumab.
Fludrocortisone The risk or severity of adverse effects can be increased when Fludrocortisone is combined with Mosunetuzumab.
Mycophenolate mofetil The risk or severity of adverse effects can be increased when Mycophenolate mofetil is combined with Mosunetuzumab.
Daunorubicin The risk or severity of adverse effects can be increased when Daunorubicin is combined with Mosunetuzumab.
Irinotecan The metabolism of Irinotecan can be decreased when combined with Mosunetuzumab.
Methimazole The risk or severity of adverse effects can be increased when Methimazole is combined with Mosunetuzumab.
Mometasone The risk or severity of adverse effects can be increased when Mometasone is combined with Mosunetuzumab.
Etoposide The metabolism of Etoposide can be decreased when combined with Mosunetuzumab.
Sulfasalazine The risk or severity of adverse effects can be increased when Sulfasalazine is combined with Mosunetuzumab.
Dacarbazine The metabolism of Dacarbazine can be decreased when combined with Mosunetuzumab.
Temozolomide The risk or severity of adverse effects can be increased when Temozolomide is combined with Mosunetuzumab.
Penicillamine The risk or severity of adverse effects can be increased when Penicillamine is combined with Mosunetuzumab.
Prednisolone The risk or severity of adverse effects can be increased when Prednisolone is combined with Mosunetuzumab.
Tacrolimus Tacrolimus may increase the immunosuppressive activities of Mosunetuzumab.
Sirolimus The metabolism of Sirolimus can be decreased when combined with Mosunetuzumab.
Mechlorethamine The risk or severity of adverse effects can be increased when Mechlorethamine is combined with Mosunetuzumab.
Azacitidine The risk or severity of adverse effects can be increased when Azacitidine is combined with Mosunetuzumab.
Carboplatin The risk or severity of adverse effects can be increased when Carboplatin is combined with Mosunetuzumab.
Methylprednisolone The risk or severity of adverse effects can be increased when Methylprednisolone is combined with Mosunetuzumab.
Dactinomycin The risk or severity of adverse effects can be increased when Dactinomycin is combined with Mosunetuzumab.
Cytarabine The risk or severity of adverse effects can be increased when Cytarabine is combined with Mosunetuzumab.
Azathioprine The risk or severity of adverse effects can be increased when Azathioprine is combined with Mosunetuzumab.

Target Protein

B-lymphocyte antigen CD20 MS4A1
T-cell surface glycoprotein CD3 epsilon chain CD3E

Referensi & Sumber

Synthesis reference: Ast, O., et al. (2018). Bispecific T cell activating antigen binding molecules (U.S. Patent No. 9,914,776 B2). U.S. Patent and Trademark Office. https://patentimages.storage.googleapis.com/e5/93/68/6ded0d607c0070/US9914776.pdf
Artikel (PubMed)
  • PMID: 34914545
    Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, O'Hear C, Huang H, Kwan A, Li CC, Piccione EC, Wei MC, Yin S, Bartlett NL: Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491. doi: 10.1200/JCO.21.00931. Epub 2021 Dec 16.
  • PMID: 33946635
    Salvaris R, Ong J, Gregory GP: Bispecific Antibodies: A Review of Development, Clinical Efficacy and Toxicity in B-Cell Lymphomas. J Pers Med. 2021 Apr 29;11(5). pii: jpm11050355. doi: 10.3390/jpm11050355.
  • PMID: 25972002
    Sun LL, Ellerman D, Mathieu M, Hristopoulos M, Chen X, Li Y, Yan X, Clark R, Reyes A, Stefanich E, Mai E, Young J, Johnson C, Huseni M, Wang X, Chen Y, Wang P, Wang H, Dybdal N, Chu YW, Chiorazzi N, Scheer JM, Junttila T, Totpal K, Dennis MS, Ebens AJ: Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies. Sci Transl Med. 2015 May 13;7(287):287ra70. doi: 10.1126/scitranslmed.aaa4802.

Contoh Produk & Brand

Produk: 4 • International brands: 1
Produk
  • Lunsumio
    Concentrate • 30 mg/30mL • Intravenous • US • Approved
  • Lunsumio
    Concentrate • 1 mg/1mL • Intravenous • US • Approved
  • Lunsumio
    Injection, solution, concentrate • 1 mg • Intravenous • EU • Approved
  • Lunsumio
    Injection, solution, concentrate • 30 mg • Intravenous • EU • Approved
International Brands
  • Lunsumio — Roche

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