VANFLYTA is the
first and only once-daily, oral
FLT3-ITD+ AML targeted treatment

For patients with newly diagnosed AML with the aggressive FLT3-ITD mutation1

VANFLYTA Dosing Snapshot2

VANFLYTA dosing snapshot image Swipe to the left
VANFLYTA dosing snapshot image

VANFLYTA is not indicated as maintenance monotherapy following allogeneic HSCT; improvement in overall survival with VANFLYTA in this setting has not been demonstrated.2

For patients who proceed to HSCT, VANFLYTA should be stopped 7 days before the start of a conditioning regimen.2

*For 5+2 regimen as the second induction cycle, VANFLYTA will be given on Days 6-19.2

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).2

Consolidation: 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.2

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.2

QTcF=the QT interval corrected by Fridericia’s formula.

Dosing VANFLYTA with standard chemotherapy

ECG and electrolyte monitoring2

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Prior to Initiation of Treatment

Do not start treatment with VANFLYTA if the QTcF interval is >450 ms.

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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.

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ECG 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.

ECG=electrocardiogram.

VANFLYTA patient recommendations for administration1

 
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Take orally with or without food2

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Take at approximately
the same time each day2

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Swallow tablets whole. Do not cut, crush, or chew the tablets2

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If VANFLYTA is vomited, do not administer a replacement dose; wait
until the next scheduled dose is due2

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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 day2

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Do not take 2 doses
on the same day2

VANFLYTA dose adjustments may follow an approach that meets your patient’s needs2

RECOMMENDED DOSE ADJUSTMENTS FOR ARs DURING VANFLYTA TREATMENT2*

A chart outlining modified dose recommendations for adverse reactions during VANFLYTA treatment A chart outlining modified dose recommendations for adverse reactions during VANFLYTA treatment

DOSE ADJUSTMENTS FOR CONCOMITANT USE WITH STRONG INHIBITORS2*

A chart outlining dose modifications for concomitant use with strong inhibitors A chart outlining dose modifications for concomitant use with strong inhibitors

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 inhibitor2

*Tablets should be taken orally once daily with or without food at approximately the same time each day.1

CYP3A=cytochrome P450 3A.

RECOMMENDED DOSAGE MODIFICATIONS FOR ARs2

A chart outlining recommended dosage modifications for adverse reactions Swipe to the left
A chart outlining recommended dosage modifications for adverse reactions

*Recommend bone marrow evaluation.2

Grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03).

With VANFLYTA, 34% of patients experienced a dose interruption due to ARs, 19% had a dose reduction, and 20% discontinued2

  • Adverse reactions which required dosage interruption in ≥2% of patients in the VANFLYTA arm included neutropenia (11%), thrombocytopenia (5%), and myelosuppression (3%)2
  • Adverse reactions which required dosage reductions in ≥2% of patients in the VANFLYTA arm were neutropenia (9%), thrombocytopenia (5%), and electrocardiogram QT prolonged (4%)2
  • The most frequent (≥2%) adverse reaction which resulted in permanent discontinuation in the VANFLYTA arm was sepsis (5%)2
References:

1. Daver N, Schlenk RF, Russell NH, Levis MJ. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019;33:299-312. doi:10.1038/s41375-018-0357-9. 2. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.