Peringatan Keamanan

The most frequently reported toxicities are myelosuppression and hepatic veno-occlusive disorder.

Gemtuzumab ozogamicin

DB00056

biotech approved investigational

Deskripsi

Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp. calichensis. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody FDA Label. The antibody is specifically directed against the CD33 antigen present on leukemic myeloblasts in most patients with acute myeloid leukemia (AML). By binding to the CD33 antigen on tumors, the cytotoxic agent blocks the growth of cancerous cells and causes cell death.

Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy A98. However, it was voluntarily withdrawn from the market in 2010 due to safety concerns, increased patient deaths and insufficient evidence of clinical benefit during confirmatory trials L941. On September 1 2017, gemtuzumab ozogamicin was again approved for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia but with a lower dosing regimen and a different schedule in combination with chemotherapy or on its own L941. It is also indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory) L941.

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 pediatric patients receiving a dose level of 9mg/m^2, the half life was approximately 64±44 h after the first dose [A20377].
Volume Distribusi The volume of distribution at steady state (Vss) was approximately 6.5 ± 5.5 L in pediatric patients receiving a dose level of 9mg/m^2 [A20377].
Klirens (Clearance) The mean clearance rate was approximately 0.12±0.15 L/h/m^2 in pediatric patients receiving a dose level of 9mg/m^2 [A20377].

Absorpsi

In pediatric patients receiving a dose level of 9mg/m^2, the peak plasma concentration (Cmax) was approximately 3.47±1.04 mg/L with the AUC of 136 ±107 mg * h/L A20377.

Metabolisme

Metabolic studies indicate hydrolytic release of the calicheamicin derivative from gemtuzumab ozogamicin. The drug is most likely removed by opsonization via the reticuloendothelial system.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

Myeloid cell surface antigen CD33 CD33
Low affinity immunoglobulin gamma Fc region receptor III-B FCGR3B
Low affinity immunoglobulin gamma Fc region receptor III-A FCGR3A
High affinity immunoglobulin gamma Fc receptor I FCGR1A

Referensi & Sumber

Artikel (PubMed)
  • PMID: 11410481
    Bross PF, Beitz J, Chen G, Chen XH, Duffy E, Kieffer L, Roy S, Sridhara R, Rahman A, Williams G, Pazdur R: Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res. 2001 Jun;7(6):1490-6.
  • PMID: 11466696
    Giles FJ, Kantarjian HM, Kornblau SM, Thomas DA, Garcia-Manero G, Waddelow TA, David CL, Phan AT, Colburn DE, Rashid A, Estey EH: Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer. 2001 Jul 15;92(2):406-13.
  • PMID: 12738663
    Wadleigh M, Richardson PG, Zahrieh D, Lee SJ, Cutler C, Ho V, Alyea EP, Antin JH, Stone RM, Soiffer RJ, DeAngelo DJ: Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood. 2003 Sep 1;102(5):1578-82. Epub 2003 May 8.
  • PMID: 15286091
    Buckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR: Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia. J Clin Pharmacol. 2004 Aug;44(8):873-80.

Contoh Produk & Brand

Produk: 3 • International brands: 0
Produk
  • Mylotarg
    Injection, powder, lyophilized, for solution • 5 mg/5mL • Intravenous • US • Approved
  • Mylotarg
    Powder, for solution • 4.5 mg / vial • Intravenous • Canada • Approved
  • Mylotarg
    Injection, powder, for solution • 5 mg • Intravenous • EU

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