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Vanflyta
quizartinib
Black Box Warnings .
Appropriate Use
restricted distribution program (VANFLYTA REMS) due to risk of QT prolongation, torsades de pointes, and cardiac arrest; prescribers and pharmacies must enroll at 1-855-212-6670 or www.VANFLYTAREMS.com
QT Prolongation, Torsades de Pointes and Cardiac Arrest
dose- and concentration-related QT prolongation, torsades de pointes, and cardiac arrest occurred; do not admin. to pts w/ severe hypokalemia, severe hypomagnesemia, long QT syndrome; do not start tx or escalate dose if QTcF >450 msec; monitor for hypokalemia or hypomagnesemia and correct deficiencies before and during tx; obtain ECG to monitor QT at baseline, qwk during induction and consolidation tx, qwk for at least 1mo after maintenance tx start, then periodically; monitor ECG more frequently if must coadminister w/ drugs known to prolong QT; reduce dose if use concomitantly w/ strong CYP3A4 inhibitors; reduce dose if QTc 481-500, interrupt then reduce dose if QTc >500, permanently D/C if recurrent QTc >500 or QT prolongation w/ s/sx of life-threatening arrhythmia
Adult Dosing .
Dosage forms: TAB: 17.7 mg, 26.5 mg
Restricted Distribution in US
- [1-855-212-6670 or www.VANFLYTAREMS.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
FLT3 internal tandem duplication (ITD)-positive AML, newly diagnosed
- [induction tx]
- Dose: 35.4 mg PO qd x14 days of each cycle for up to 2 cycles; Start: on day 8 if in combo w/ 7+3 cytarabine and anthracycline regimen, or on day 6 if in combo w/ 5+2 cytarabine and anthracycline regimen; Info: do not cut/crush/chew tab
- [consolidation tx]
- Dose: 35.4 mg PO qd on days 6-19 of each cycle for up to 4 cycles; Info: use w/ high-dose cytarabine; do not cut/crush/chew tab
- [maintenance tx]
- Dose: 26.5-53 mg PO qd on days 1-28 of 28-day cycle for up to 36 cycles; Start: 26.5 mg PO qd on days 1-14 of cycle 1 if QTc <450 msec, incr. dose to 53 mg PO qd starting day 15 of cycle 1 if QTc <450 msec, or cont. 26.5 mg PO qd if QTc >500 msec observed during induction or consolidation tx; begin after consolidation tx upon blood count recovery of ANC >500 and PLT >50,000; Info: do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.