Gemtuzumab ozogamicin (Mylotarg™)

OFFICE ADMINISTRATION

Indications for Prior Authorization:
  • Treatment of adults with newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older
  • 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 1 month or age 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):
    • Adults:
      • 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) in combination with daunorubicin and cytarabine.
    • Pediatric patients 1 month and older:
      • Mylotarg™ is given once in combination with standard chemotherapy.  No Mylotarg™ is given in the second induction cycle.  No Mylotarg™ is given in the first or third intensifications cycles.  For intensification 2, Mylogarg™ is given once in combination with standard chemotherapy.  Consider risks/benefits before given Mylotarg™ during intensification 2.
        • BSA at least 0.6 m2: 3 mg/m2
        • BSA < 0.6 m2: 0.1 mg/kg
  • 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 as a single course of Mylotarg™
  • Premedicate with a corticosteroid, antihistamine and acetaminophen prior to Mylotarg
  • See package insert for full dosing and premedication details

Last review date: November 13, 2018

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