Safety Profile

MYLOTARG safety profile in a Phase 3, randomized, open-label study
In AML-19, single-agent MYLOTARG demonstrated a comparable safety profile to BSC1,2
  • The rates of serious AEs were similar in the 2 groups, and no excess mortality from AEs was observed with MYLOTARG
  • 60-day mortality was lower in patients receiving MYLOTARG vs BSC (17.8% vs 30.4%)
  • No cases of VOD were reported out of 111 patients treated with MYLOTARG
  • Hepatotoxicity, including severe or fatal VOD, also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG
Strategies to manage hepatotoxicity, including VOD1
Prior to each dose of MYLOTARG
  • Assess ALT, AST, total bilirubin, and alkaline phosphatase
After treatment with MYLOTARG
  • Monitor frequently for signs and symptoms of VOD, such as:
    Elevations in ALT or AST
    Elevations in total bilirubin
    Rapid weight gain
    Ascites
    Hepatomegaly (which may be painful)
  • Monitoring only total bilirubin may not identify all patients at risk of VOD
  • For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended
  • Manage signs or symptoms of hepatic toxicity by dose interruption or discontinuation of MYLOTARG. In patients who experience VOD, discontinue MYLOTARG and treat according to standard medical practice
AE=adverse event; BSC=best supportive care; VOD=veno-occlusive liver disease.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial. J Clin Oncol. 2016;34(9):972-979.