For treatment-eligible patients with newly diagnosed FLT3-ITD+ AML Start and stay with VANFLYTA—The only FLT3 inhibitor indicated for INDUCTION, CONSOLIDATION, AND MAINTENANCE1-3* *Please see Full Indication, including Limitations of Use, below.
VANFLYTA Dosing Snapshot1
For patients who proceed to HSCT, VANFLYTA should be stopped 7 days before the start of a conditioning regimen.1
*Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic HSCT; improvement in overall survival with VANFLYTA in this setting has not been demonstrated.1
†For 5+2 regimen as the second induction cycle, VANFLYTA will be given on Days 6-19.1
Tablets shown are not actual size.
Induction: 35.4 mg orally once daily on Days 8-21 of 7+3 (cytarabine [100 or 200 mg/m2/day] on Days 1-7 plus daunorubicin [60 mg/m2/day] or idarubicin [12 mg/m2/day] on Days 1-3) and on Days 8-21 or 6-19 of an optional second induction (7+3 or 5+2 [5 days cytarabine plus 2 days daunorubicin or idarubicin], respectively).1
Consolidate: 35.4 mg orally once daily on Days 6-19 of high-dose cytarabine (1.5 to 3.0 g/m2 every 12 hours on Days 1, 3, and 5) for up to 4 cycles.1
Maintenance: 26.5 mg orally once daily on Days 1-14 and 53 mg orally once daily thereafter for up to thirty-six 28-day cycles.1
Dosing VANFLYTA with standard chemotherapy1
ECG and electrolyte monitoring1
Prior to Initiation of Treatment
Do not start treatment with VANFLYTA if the QTcF interval is >450 ms.1
Prior to and During Treatment
Monitor and correct hypokalemia and hypomagnesemia. Maintain electrolytes in the normal range. Monitor electrolytes and perform ECGs more frequently in patients who experience diarrhea or vomiting.1ECG Monitoring
Perform ECG monitoring of the QT interval more frequently in patients who are at significant risk of developing QT interval prolongation and torsades de pointes, or following dose escalation.1VANFLYTA patient recommendations for administration1
Take orally with or without food1
Take at approximately
the same time
each day1
If VANFLYTA is vomited, do not administer a replacement dose; wait until the next scheduled dose1
If a dose of VANFLYTA is missed or not taken at the usual time, administer the dose as soon as possible on the same day and return to the normal schedule the following day1
Do not take 2 doses on the same day1
VANFLYTA offers
once-daily
dosing1
VANFLYTA offers
once-daily
dosing1
Not actual size.
Not actual size.
VANFLYTA dose adjustments may follow an approach that meets your patient’s needs1
RECOMMENDED DOSE ADJUSTMENTS FOR ARs DURING VANFLYTA TREATMENT1*
DOSE ADJUSTMENTS FOR CONCOMITANT USE WITH STRONG INHIBITORS1*
*Tablets should be taken orally once daily with or without food at approximately the same time each day.1
If the current dosage is 17.7 mg once daily, interrupt VANFLYTA treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the VANFLYTA dose that was taken before initiating the strong inhibitor1
RECOMMENDED DOSAGE MODIFICATIONS FOR ARs1
*Recommend bone marrow evaluation.1
Grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03).
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)–positive as detected by an FDA-approved test.
Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.
AML=acute myeloid leukemia; AR=adverse reaction; CYP3A=cytochrome P450 3A; ECG=electrocardiogram; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; QTcF=the QT interval corrected by Fridericia's formula.
1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023.