For patients receiving MYLOTARG in combination therapy |
Persistent thrombocytopenia | - Adults: If platelet count does not recover to greater than or equal to 100 Gi/L within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles).
- Pediatrics: Patients should have a platelet count of 75 Gi/L before the next cycle (induction or intensification).
|
Persistent neutropenia | - Adults: If neutrophil count does not recover to greater than 0.5 Gi/L within 14 days following the planned start date of the consolidation cycle (14 days after hematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles).
- Pediatrics: Patients should have a neutrophil count of 1 Gi/L before the next cycle (induction or intensification).
|
For all patients receiving MYLOTARG (Monotherapy or in Combination) |
VOD | |
Total bilirubin greater than 2 × ULN, or AST and/or ALT greater than 2.5 × ULN | - Delay treatment with MYLOTARG until recovery of total bilirubin to less than or equal to 2 × ULN and AST and ALT to less than or equal to 2.5 × ULN prior to each dose.
- Omit scheduled dose if delayed more than 2 days between sequential infusions.
|
Infusion-related reactions | - Interrupt the infusion and institute appropriate medical management.
- Administer acetaminophen, diphenhydramine and/or methylprednisolone, if needed [see Dosage and Administration (2.1)]
- Provide supportive care measures as needed.
- For mild, moderate or severe infusion-related reactions, once symptoms resolve, consider resuming the infusion at no more than half the rate at which the reaction occurred. Repeat the procedure above in the event of recurrence of symptoms.
- Permanently discontinue MYLOTARG upon occurrence of a severe infusion reaction or for any life-threatening infusion reaction [see Warnings and Precautions (5.2)].
|
Other severe or life-threatening non-hematologic toxicities | - Delay treatment with MYLOTARG until recovery to a severity of no more than mild.
- Omit scheduled dose if delayed more than 2 days between sequential infusions.
|