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Patient Fitness in AML

The content of this website has been produced in line with the MYLOTARG® (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. For  MYLOTARG® (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

Dosing and Administration

The use of fractionated doses of MYLOTARG significantly* improves EFS and RFS in patients with de novo AML compared with standard front-line chemotherapy1

Dosing and administration information2

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 remissionafter 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

Please refer to the MYLOTARG Summary of Product Characteristics for full details LoadingExplore more

Pharmacy Guide

Download the Pharmacy Guide for information for pharmacists on MYLOTARG treatment. SmPC should be consulted for full guidance

Download Pharmacy Guide Loading

Dosing Guide

Download the HCP dosing summary which is a guide to treatment with MYLOTARG​​​​​​​. SmPC should be consulted for full guidance.

Download Dosing Guide Loading

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

References:

Castaigne S, et al. Lancet 2012;379:1508-1516MYLOTARG Summary of Product Characteristics for Great Britain click here. MYLOTARG Summary of Product Characteristics for Northern Ireland click here.
PP-MYL-GBR-0685. April 2023

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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