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Treatment Name: Gemtuzumab Ozogamicin (Mylotarg®)

Gemtuzumab Ozogamicin (Mylotarg®) is a Chemotherapy Regimen for Acute Myeloid Leukemia (AML)

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1) Taksin AL, Legrand O, Raffoux E, et al. High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia. 2007;21:66-71.

2) Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncol. 2016;34:972-979.

Created: February 28, 2019 Updated: February 28, 2019

What is Acute Myeloid Leukemia (AML)?

A disease of the myeloid cells found in the bone marrow. Myeloid cells are responsible for developing into mature white blood cells, red blood cells, and platelets. In AML, immature myeloid cells know as “blasts” replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop. Common symptoms of this include fatigue, difficulty exercising, or easy bruising or bleeding.

Most cases of AML are considered “de novo” meaning that the cause is unknown. However, there are a few known risk factors for AML, such as exposure to radiation, various environmental toxins, and certain chemotherapy agents. There is no staging system for AML. Chromosomes (strands of DNA) are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Gemtuzumab Ozogamicin (Mylotarg®) starting doses

For relapse/refractory AML

  • Gemtuzumab ozogamicin 3 mg/m2 (maximum 4.5 mg) intravenous (I.V.) infusion over 2 hours on Days 1, 4, and 7


For newly diagnosed AML

  • Induction: Gemtuzumab ozogamicin 6 mg/m2 I.V. infusion over 2 hours on Day 1 and 6 mg/m2 intravenous infusion over 2 hours on Day 8
  • Continuation: Gemtuzumab ozogamicin 2 mg/m2 I.V. infusion over 2 hours on Day 1