MYLOTARG (gemtuzumab ozogamicin)
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
- 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.
- Adults:
- 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
- Continuation: 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