Fractionated Dosing & Dose Modifications

FRACTIONATED DOSING

Fractionated MYLOTARG allows for optimized drug delivery in relapsed/refractory AML1,2
Single-agent fractionated MYLOTARG dosing regimen1
  • Treatment in the relapsed or refractory setting consists of a single course of MYLOTARG
Before starting MYLOTARG1
  • 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
  • For children, premedicate with acetaminophen 15 mg/kg (maximum of 650 mg), diphenhydramine 1 mg/kg (maximum of 50 mg), and 1 mg/kg methylprednisolone orally or intravenously; additional doses of acetaminophen and diphenhydramine may be administered every 4 hours after the initial pretreatment dose
  • 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
Cytoreduction1
  • 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.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc. 
2. Taksin AL, Legrand O, Raffoux E, et al. High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia. 2007;21(1):66-71.

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; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno-occlusive liver disease.
REFERENCE
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.