Dosing and Administration

The use of fractionated lower doses of MYLOTARG™ allows the delivery of higher cumulative doses and significnantly* 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. For patients experiencing a CR after induction, up to two consolidation courses are recommended.1,2 

Daily MYLOTARG™ dose capped at one 5 mg vial.

View the ALFA 0701 study 

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

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

§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).

*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.
 

Additional administration information1

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AML, acute myeloid leukaemia; ANC, absolute neutrophil count; AST, aspartate aminotransferase; CR, complete remission; EFS, event-free survival;  IV, intravenous;  OS, overall survival; RFS, relapse-free survival; UV, ultraviolet; VOD, veno-occlusive disease.

References

1. MYLOTARG™ Summary of Marketing Product Characteristics.

2. Castaigne S, et al. Lancet 2012;379:1508-1516

PP-MYL-GBR-0168. December 2019