Fractionated Dosing & Dose Modifications

mylotarg-ndaa-comb-dosing

FRACTIONATED DOSING

For adult patients with newly diagnosed AML, fractionated MYLOTARG allows for optimized drug delivery1,2
  • A treatment course including MYLOTARG in combination therapy for adults consists of 1 cycle of induction and 2 cycles of consolidation
  • If complete response is not achieved, MYLOTARG should not be administered during second induction
Before starting MYLOTARG
  • Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to MYLOTARG dosing and 1 mg/kg methylprednisolone or an equivalent dose of an alternative corticosteroid within 30 minutes prior to infusion of MYLOTARG
  • Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction, such as fever, chills, hypotension, or dyspnea during the infusion or within 4 hours afterwards
Cytoreduction
  • For patients with hyperleukocytosis (leukocyte count ≥30,000/mm3), cytoreduction is recommended prior to administration of MYLOTARG
  • Use appropriate measures to prevent tumor lysis syndrome
AML=acute myeloid leukemia; AraC=cytarabine; DNR=daunorubicin.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc. 
2. Castaigne S, Pautas C, Terré C, et al; for the Acute Leukemia French Association. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-1516.

DOSE MODIFICATION

Dose modifications for toxicities1
  • Monitor blood counts frequently through resolution of cytopenias
  • Monitor blood counts and chemistries at least 3 times per week through recovery from treatment-related toxicities
  • Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG
ALT=alanine aminotransferase; AML=acute myeloid leukemia; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno-occlusive liver disease.
REFERENCE
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.