Gemtuzumab ozogamicin (Mylotarg™)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of adults with newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults
  • Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older

Patients must meet the following criteria for the indication(s) above:

  • Prescribed by a specialist, AND
  • Patient is 18 years or older and has newly-diagnosed CD33-positive AML, OR at least 2 years old and has relapsed or refractory CD33-positive AML

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee:

  • All used not listed in the approved indications

Recommended Dosing:

  • Newly-diagnosed, de novo AML (combination regimen):
    • Induction: 3 mg/m2 (up to one 4.5 mg vial) on days 1, 4, and 7 in combination with daunorubicin and cytarabine.
    • Consolidation: 3 mg/m2 day 1 (up to one 4.5 mg vial) on in combination with daunorubicin and cytarabine.
  • Newly-diagnosed AML (single-agent regimen):
    • Induction: 6 mg/m2 (not limited to one 4.5 mg vial) on days 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8
    • Continutation: For patients without evidence of disease progression following induction, up to 8 continuation courses of Mylotarg 2 mg/m2 (not limited to one 4.5 mg vial) on day 1 every 4 weeks
  • Relpased or refractory AML (single-agent regimen):
    • 3 mg/m2 (up to one 4.5 mg vial) on days 1, 4, and 7
  • Premedicate with a corticosteroid, antihistamine and acetaminophen 1 hour prior to Mylotarg

Last review date: November 13, 2018