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Information on how to access Mylotarg™​​​​​​​​​​​​​​ (gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting can be found at the bottom of the page.

Dosing and Administration

The use of fractionated doses of MYLOTARG allows the delivery of higher cumulative doses and significantly* improves EFS and RFS in patients with AML compared with standard front-line chemotherapy1

Dosing and administration information1

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 Day 1 to 3 and cytarabine (AraC) by continuous infusion on Day 1 to 7.

Daily MYLOTARG dose capped at one 5 mg vial.

​​​​​​​‡Cytarabine administered by continuous infusion during induction (total dosing 200 mg/m2 per day).

*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

For patients who do not experience a CR† after induction, a second induction may be required.  MYLOTARG should not be administered during a second induction if a second induction is required1

For patients experiencing a Complete Remission (CR)† after induction, up to two consolidation courses are recommended.1,2

§Cytarabine administered over 2 hours 1 g/m2 every 12 hours on Days 1–3 during second induction, and Days 1–4 during consolidation (total dosing 2 g/m2 per day).

†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, light sensitivity and monitoring during infusion, please click here

Please view MYLOTARG SmPC for more information

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Pharmacy Guide

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

Download Pharmacy Guide

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

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


▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References
  1. MYLOTARG Summary of Marketing Product Characteristics.
  2. Castaigne S, et al. Lancet 2012;379:1508-1516
PP-MYL-GBR-0230. March 2021

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PP-PFE-GBR-2688. December 2020

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