Peringatan Keamanan

Blinatumomab overdose cases have been reported, including a patient that received 133-fold the recommended therapeutic dose over a short period of time. In a study that included pediatric and adolescent patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a patient receiving 30 mcg/m2/day of blinatumomab (higher than the maximum tolerated dose) experienced a fatal cardiac failure event in the setting of life-threatening cytokine release syndrome (CRS).L44311 The adverse reactions observed during blinatumomab overdoses included fever, tremors, and headache, consistent with those observed at the recommended dose. If a patient is experiencing an overdose, the blinatumomab product label recommends to interrupt the infusion, monitor the patient for signs of adverse reactions, and provide supportive care. Re-initiating blinatumomab at the recommended dose should be considered after all adverse reactions have been resolved and no earlier than 12 hours after the infusion is interrupted.L44311 The carcinogenic, genotoxic, and fertility effects of blinatumomab have not been evaluated.L44311

Blinatumomab

DB09052

biotech approved investigational

Deskripsi

Blinatumomab is a BiTE-class (bi-specific T-cell engager) constructed monoclonal antibody formed by the recombinant fusion of an anti-CD3 single-chain variable fragment (scFV) and an anti-CD19 scFV through a short peptide linker.A254836,L44311 CD3 is an antigen expressed on the surface of T-cells, while CD19 is mostly expressed on the surface of malignant B-cells. Since blinatumomab has an affinity to both antigens, it redirects T-cells to tumor cells expressing CD19 and promotes tumor cell lysis and apoptosis.A7659,A7660,A254831

Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto. It was first approved by the FDA in December 2014 for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in relapsed and refractory patients. In March 2018, it was approved under the FDA’s accelerated approval program for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.L44311 Full approval for this indication was granted in June 2023.L46991,L46996

Blinatumomab has a short half-life, requiring patients to receive a continuous infusion over 4-week cycles using a portable mini-pump for optimum delivery.A254826

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) Blinatumomab has a half-life of 2.10 hours. In pediatric patients, the half-life was 2.19 hours in the first cycle of blinatumomab at the recommended dose.[L44311]
Volume Distribusi Blinatumomab has a volume of distribution based on terminal phase of 4.35 L.[L44311]
Klirens (Clearance) Blinatumomab has an estimated systemic clearance of 3.11 L/hour in patients receiving blinatumomab with continuous intravenous infusion. There is a 2-fold difference in clearance values between patients with normal renal function and those with moderate renal impairment. Pediatric patients had an estimated clearance of 1.88 L/hour/m<sup>2</sup> in the first cycle of blinatumomab at the recommended dose.[L44311]

Absorpsi

In adult patients, the pharmacokinetic profile of blinatumomab appears to be linear between 5 to 90 mcg/m2/day (equivalent to 9 to 162 mcg/day). The steady-state serum concentration (Css) of blinatumomab was achieved within a day of continuous intravenous infusion, and in the range tested, the mean Css was approximately dose-proportional. At the clinical doses for the treatment of relapsed or refractory acute lymphoblastic leukemia (9 mcg/day and 28 mcg/day), the Css was 228 (356) pg/mL and 616 (537) pg/mL, respectively.L44311

Metabolisme

The metabolic pathway of blinatumomab has not been characterized. As a monoclonal antibody, blinatumomab is expected to be metabolized into small peptides and amino acids via catabolic pathways.L44311

Rute Eliminasi

At clinical doses, negligible amounts of blinatumomab were excreted in the urine.L44311

Interaksi Obat

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

Target Protein

B-lymphocyte antigen CD19 CD19
T-cell surface glycoprotein CD3 delta chain CD3D

Referensi & Sumber

Synthesis reference: Kufer, P et al. (2017). Anti-leukocyte adhesion for the mitigation of potential adverse events caused by CD3-specific binding domains. (U.S. Patent No. 9,688,760 B2). U.S. Patent and Trademark Office. https://patentimages.storage.googleapis.com/a1/59/c9/e0a1c48f125447/US9688760.pdf
Artikel (PubMed)
  • PMID: 25883042
    Zugmaier G, Klinger M, Schmidt M, Subklewe M: Clinical overview of anti-CD19 BiTE((R)) and ex vivo data from anti-CD33 BiTE((R)) as examples for retargeting T cells in hematologic malignancies. Mol Immunol. 2015 Oct;67(2 Pt A):58-66. doi: 10.1016/j.molimm.2015.02.033. Epub 2015 Apr 13.
  • PMID: 25359367
    Garber K: Bispecific antibodies rise again. Nat Rev Drug Discov. 2014 Nov;13(11):799-801. doi: 10.1038/nrd4478.
  • PMID: 25524799
    Thomas X: Blinatumomab: a new era of treatment for adult ALL? Lancet Oncol. 2015 Jan;16(1):6-7. doi: 10.1016/S1470-2045(14)71183-0. Epub 2014 Dec 16.
  • PMID: 25524800
    Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foa R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Bruggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM: Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16.
  • PMID: 23812940
    Wong R, Pepper C, Brennan P, Nagorsen D, Man S, Fegan C: Blinatumomab induces autologous T-cell killing of chronic lymphocytic leukemia cells. Haematologica. 2013 Dec;98(12):1930-8. doi: 10.3324/haematol.2012.082248. Epub 2013 Jun 28.

Contoh Produk & Brand

Produk: 3 • International brands: 1
Produk
  • Blincyto
    Injection, powder, lyophilized, for solution; Kit • 12.5 ug/1mL • Intravenous • US • Approved
  • Blincyto
    Powder, for solution • 38.5 mcg / vial • Intravenous • Canada • Approved
  • Blincyto
    Solution • 38.5 mcg • Intravenous • EU • Approved
International Brands
  • Blincyto — Amgen Inc.

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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