Usual Adult Dose for of Mylotarg Acute Myeloid Leukemia:
Newly-diagnosed CD33-positive acute myeloid leukemia (AML):
COMBINATION REGIMEN (therapy consists of 1 induction cycle and 2 consolidation cycles in combination with chemotherapy):
-Induction: 3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7 in combination with daunorubicin and cytarabine (for patients who require a second induction cycle, gemtuzumab is NOT given during the second induction cycle)
-Consolidation (2 cycles): 3 mg/m2 (maximum 4.5 mg/dose) IV on Day 1 in combination with daunorubicin and cytarabine
Newly-diagnosed CD33-positive acute myeloid leukemia (AML):
SINGLE AGENT REGIMEN (MONOTHERAPY) (therapy consists of 1 induction cycle and up to 8 continuation cycles):
-Induction: 6 mg/m2 IV on Day 1 and 3 mg/m2 IV on Day 8
-Continuation: 2 mg/m2 IV on Day 1 every 4 weeks
Relapsed or Refractory CD33-positive AML:
SINGLE AGENT REGIMEN (MONOTHERAPY):
3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7
-Treatment in the relapsed or refractory setting consists of a single course of gemtuzumab.
Comments:
-Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or IV one hour prior to infusion, and methylprednisolone (or equivalent) 1 mg/kg orally or IV within 30 minutes prior to infusion. Repeat the same dose of methylprednisolone (or equivalent) for any sign of an infusion reaction (e.g., fever, chills, hypotension, dyspnea) during the infusion or within 4 hours of the infusion.
-Monitor vital signs during infusion and for 4 hours following infusion.
-For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of this drug.
Usual Pediatric Dose of Mylotarg for Acute Myeloid Leukemia:
Newly Diagnosed De Novo CD33-positive AML (Combination Regimen):
ONE MONTH AND OLDER:
-Body surface area (BSA) less than 0.6 m2: 0.1 mg/kg
-BSA 0.6 m2 or greater: 0.3 mg/m2
INDUCTION 1:
-For Induction 1, gemtuzumab is given once in combination with standard chemotherapy; no gemtuzumab is given in the second induction cycle.
INTENSIFICATION:
-No gemtuzumab is given in the first or third intensification cycles; for Intensification 2, gemtuzumab is given once in combination with standard chemotherapy; consider the risks and potential benefits before giving gemtuzumab during Intensification 2.
Relapsed or Refractory CD33-positive AML:
SINGLE AGENT REGIMEN (MONOTHERAPY):
2 YEARS AND OLDER:
3 mg/m2 (maximum 4.5 mg/dose) IV on Days 1, 4, and 7
-Treatment in the relapsed or refractory setting consists of a single course of gemtuzumab.
Comments:
-Premedicate children 1 month and older with acetaminophen 15 mg/kg (maximum of 650 mg) orally and diphenhydramine 1 mg/kg (maximum of 50 mg) orally or IV within 1 hour of infusion, and methylprednisolone 1 mg/kg orally or IV within 30 minutes of infusion. Additional doses of acetaminophen and diphenhydramine may be administered every 4 hours if needed. Repeat with the same dose of methylprednisolone (or equivalent) for an infusion reaction (e.g., fever, chills, hypotension, dyspnea) during the infusion or within 4 hours of the infusion.
-Monitor vital signs during infusion and for 4 hours following infusion.
-For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of this drug.
 Detailed Mylotarg dosage information
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Mylotarg.
What happens if I overdose?
Since Mylotarg is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
