The use of fractionated doses of MYLOTARG significantly* improves EFS and RFS in patients with de novo AML compared with standard front-line chemotherapy1
MYLOTARG is administered as an IV infusion over a 2-hour period on days 1, 4, and 7 in combination with daunorubicin (DNR) infused over 30 minutes on days 1 to 3 and cytarabine (AraC) by continuous infusion on days 1 to 7.
Daily MYLOTARG dose capped at one 5 mg vial.
For patients who do not experience a complete remission (CR)† after induction, a second induction may be required. MYLOTARG should not be administered during a second induction if a second induction is required2
For patients experiencing a complete remission† after induction, up to two consolidation courses are recommended.2
*p values: EFS, p=0.0002; RFS, p=0.0006; MYLOTARG+ chemotherapy vs chemotherapy alone. Median OS was higher with MYLOTARG+ chemotherapy vs chemotherapy alone, but the difference was not statistically significant.
†Defined as <5% blasts in a normocellular marrow and an ANC of >1.0 × 109 cells/L with a platelet count of ≥100 × 109/L in the peripheral blood in the absence of transfusion. Original study allowed consolidation for patients with a complete remission with incomplete platelet recovery (CRp) but dosing modifications preclude the use of MYLOTARG for consolidation in patients with a platelet count of < 100,000/mm3.
For additional adminstration information on use in pregnancy, pre-medication, reconstitution and monitoring during infusion, please click here
Download the Pharmacy Guide for information for pharmacists on MYLOTARG treatment. SmPC should be consulted for full guidance
Download the HCP dosing summary which is a guide to treatment with MYLOTARG. SmPC should be consulted for full guidance.
AML, acute myeloid leukaemia; ANC, absolute neutrophil count; CR, complete remission; EFS, event-free survival; HCP, Healthcare Professional; IV, intravenous; OS, overall survival; RFS, relapse-free survival; SmPC, Summary of Product Characteristics
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