Quizartinib: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 22, 2026🚩 Report this page

Quizartinib

Other Protein Kinase Inhibitors

Sold as Vanflyta

GB MHRAEU EMACA Health Canada

Drug class: Other Protein Kinase Inhibitors
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 5

Overview

Quizartinib is an active pharmaceutical ingredient in the Other Protein Kinase Inhibitors group (L01EX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	March 20, 2026
EU European Union	EMA	1	February 5, 2026
CA Canada	Health Canada	2	April 22, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised March 20, 2026[1]

VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised February 5, 2026[2]

VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

How to take

CACanada· Health Canada

2 products

2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

VANFLYTADAIICHI SANKYO PHARMA CANADA LIMITED

Sources & citations

[1]MHRA (UK) · PLGB082650048 · revised March 20, 2026
[2]European Medicines Agency · EMEA/H/C/005910 · revised February 5, 2026
[3]Health Canada (DPD) · 02558351 · revised April 22, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment with VANFLYTA should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking VANFLYTA, AML patients must have confirmation of FLT3-ITD positive AML using a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose.
If a CE-marked IVD is not available, confirmation of FLT3-ITD positive AML should be assessed by an alternate validated test. 4). 7 mg) once daily for two weeks in each cycle of induction. 5 mg once daily. 4). Single-agent maintenance therapy may be continued for up to 36 cycles.
For additional dosing information see Tables 1 to 3. 5 mg once daily for two weeks if QTcF is ≤ 450 ms. • After two weeks, if QTcF is ≤ 450 ms, the dose should be increased to 53 mg once daily. Duration (28-day cycles) Two weeks in each cycle Two weeks in each cycle Once daily with no break between cycles for up to 36 cycles.
a Patients can receive up to 2 cycles of induction. b Patients can receive up to 4 cycles of consolidation. c For 5 + 2 regimen as the second induction cycle, VANFLYTA will be started on day 6. Haematopoietic stem cell transplantation For patients who proceed to haematopoietic stem cell transplantation (HSCT), VANFLYTA should be stopped 7 days before the start of a conditioning regimen.
It may be resumed after completion of the transplant based on white blood cell count (WBC) and at the discretion of the treating physician for patients with sufficient haematologic recovery and with ≤ Grade 2 graft-versus-host disease (GVHD), not requiring the initiation of new systemic GVHD therapy within 21 days, following the dosing recommendations described above.
4). For recommended dose modifications due to adverse reactions, see Table 2. For dose adjustments due to adverse reactions and/or concomitant use with strong CYP3A inhibitors, see Table 3.
Table 2:
Recommended dose modifications for adverse reactions Adverse reaction Recommended action QTcF 450-480 ms (Grade 1) • Continue VANFLYTA dose. QTcF 481-500 ms (Grade 2) • Reduce VANFLYTA dose (see Table 3) without interruption. • Resume VANFLYTA at the previous dose in the next cycle if QTcF has decreased to < 450 ms.
Monitor the patient closely for QT prolongation for the first cycle at the increased dose. QTcF ≥ 501 ms (Grade 3) • Interrupt VANFLYTA. • Resume VANFLYTA at a reduced dose (see Table 3) when QTcF returns to < 450 ms. • Do not escalate to 53 mg once daily during maintenance if QTcF > 500 ms was observed during induction and/or consolidation, and it is suspected to be associated with VANFLYTA.
5 mg once daily dose. , serum electrolyte abnormalities, concomitant QT prolonging medicinal products). Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of life- threatening arrhythmia (Grade 4) • Permanently discontinue VANFLYTA.
Grade 3 or 4 non- haematologic adverse reactions • Interrupt VANFLYTA. • Resume treatment at the previous dose if adverse reaction improves to ≤ Grade 1. • Resume treatment at a reduced dose (see Table 3) if adverse reaction improves to < Grade 3.
• Permanently discontinue if Grade 3 or 4 adverse reaction persists beyond 28 days and is suspected to be associated with VANFLYTA. Persistent Grade 4 neutropenia or thrombocytopenia without active bone marrow disease • Reduce the dose (see Table 3).
03). 7 mg Missed dose or vomiting If a dose of VANFLYTA is missed or not taken at the usual time, the patient should take the dose as soon as possible on the same day and return to the usual schedule the following day. The patient should not take two doses on the same day.
If the patient vomits after taking VANFLYTA, the patient should not take an additional dose that day but take the next dose the following day at the usual time. Special populations Elderly No dose adjustment is required in the elderly.
Hepatic impairment No dose adjustment is recommended for patients with mild or moderate hepatic impairment. VANFLYTA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C), as […]

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 20, 2026[1]

9%). 7%). 3%). 4%). 6%). 8%). 1%). Tabulated list of adverse reactions The safety of VANFLYTA was investigated in QuANTUM-First, a randomised, double-blind, placebo-controlled study in adult patients with newly diagnosed FLT3- ITD positive AML.
Adverse reactions are listed according to MedDRA System Organ Class (SOC). Within each SOC, the adverse reactions are ranked by frequency with the most frequent reactions first, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency category, adverse reactions are presented in order of decreasing seriousness. 4

GBOfficial regulatory label· Warnings and precautions· revised March 20, 2026[1]

8). QT interval prolongation may increase the risk of ventricular arrhythmias or torsade de pointes. Patients with congenital long QT syndrome and/or a previous history of torsade de pointes were excluded from the quizartinib development programme.
VANFLYTA must not be used in patients with congenital long QT syndrome. VANFLYTA should be used with caution in patients who are at significant risk of developing QT interval prolongation. , history of second-or third-degree heart block (without pacemaker), myocardial infarction within 6 months, uncontrolled angina pectoris, uncontrolled hypertension, congestive heart failure, history of clinically relevant ventricular arrhythmias or torsade de pointes), and patients receiving concomitant medicinal products known to prolong the QT interval.
2). Do not start treatment with VANFLYTA if the QTcF interval is greater than 450 ms. During induction and consolidation, ECGs should be performed prior to initiation and then once weekly during quizartinib treatment or more frequently as clinically indicated.
During maintenance, ECGs should be performed prior to initiation and then once weekly for the first month following dose initiation and escalation, and thereafter as clinically indicated. The maintenance starting dose should not be escalated if the QTcF interval is greater than 450 ms (see Table 1).
2). ECG monitoring of the QT interval should be performed more frequently in patients who are at significant risk of developing QT interval prolongation and torsade de pointes. Monitoring and correction of hypokalaemia and hypomagnesaemia should be performed prior to and during treatment with VANFLYTA.
More frequent monitoring of electrolytes and ECGs should be performed in patients who experience diarrhoea or vomiting. 5). 5). , older than 65 years), compared to younger patients especially in the early treatment period. Patients older than 65 years of age should be closely monitored for the occurrence of severe infections during induction.
Women of childbearing potential/Contraception in males and females Based on findings in animals, quizartinib may cause embryo-foetal harm when administered to a pregnant woman. Women of childbearing potential should undergo pregnancy testing within 7 days before starting treatment with VANFLYTA.
Women of childbearing potential should use effective contraception during treatment with VANFLYTA and for at least 7 months after the last dose. 6). Patient card The prescriber must discuss the risks of VANFLYTA therapy with the patient.
The patient will be provided with the patient card with each prescription (included in the medicinal product pack).

This is not medical advice. Consult a qualified healthcare professional.

Treatment with VANFLYTA should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking VANFLYTA, AML patients must have confirmation of FLT3-ITD positive AML using a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose.
If a CE-marked IVD is not available, confirmation of FLT3-ITD positive AML should be assessed by an alternate validated test. 4). 7 mg) once daily for two weeks in each cycle of induction. 5 mg once daily. 4). Single-agent maintenance therapy may be continued for up to 36 cycles.
For additional dosing information see Tables 1 to 3. 5 mg once daily for two weeks if QTcF is ≤ 450 ms. • After two weeks, if QTcF is ≤ 450 ms, the dose should be increased to 53 mg once daily. Duration (28-day cycles) Two weeks in each cycle Two weeks in each cycle Once daily with no break between cycles for up to 36 cycles.
a Patients can receive up to 2 cycles of induction. b Patients can receive up to 4 cycles of consolidation. c For 5 + 2 regimen as the second induction cycle, VANFLYTA will be started on day 6. Haematopoietic stem cell transplantation For patients who proceed to haematopoietic stem cell transplantation (HSCT), VANFLYTA should be stopped 7 days before the start of a conditioning regimen.
It may be resumed after completion of the transplant based on white blood cell count (WBC) and at the discretion of the treating physician for patients with sufficient haematologic recovery and with ≤ Grade 2 graft-versus-host disease (GVHD), not requiring the initiation of new systemic GVHD therapy within 21 days, following the dosing recommendations described above.
4). For recommended dose modifications due to adverse reactions, see Table 2. For dose adjustments due to adverse reactions and/or concomitant use with strong CYP3A inhibitors, see Table 3.
Table 2:
Recommended dose modifications for adverse reactions Adverse reaction Recommended action QTcF 450-480 ms (Grade 1) • Continue VANFLYTA dose. QTcF 481-500 ms (Grade 2) • Reduce VANFLYTA dose (see Table 3) without interruption. • Resume VANFLYTA at the previous dose in the next cycle if QTcF has decreased to < 450 ms.
Monitor the patient closely for QT prolongation for the first cycle at the increased dose. 4 Adverse reaction Recommended action QTcF ≥ 501 ms (Grade 3) • Interrupt VANFLYTA. • Resume VANFLYTA at a reduced dose (see Table 3) when QTcF returns to < 450 ms.
• Do not escalate to 53 mg once daily during maintenance if QTcF > 500 ms was observed during induction and/or consolidation, and it is suspected to be associated with VANFLYTA. 5 mg once daily dose. , serum electrolyte abnormalities, concomitant QT prolonging medicinal products).
Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of life- threatening arrhythmia (Grade 4) • Permanently discontinue VANFLYTA. Grade 3 or 4 non- haematologic adverse reactions • Interrupt VANFLYTA. • Resume treatment at the previous dose if adverse reaction improves to ≤ Grade 1.
• Resume treatment at a reduced dose (see Table 3) if adverse reaction improves to < Grade 3. • Permanently discontinue if Grade 3 or 4 adverse reaction persists beyond 28 days and is suspected to be associated with VANFLYTA. Persistent Grade 4 neutropenia or thrombocytopenia without active bone marrow disease • Reduce the dose (see Table 3).
03). 7 mg Missed dose or vomiting If a dose of VANFLYTA is missed or not taken at the usual time, the patient should take the dose as soon as possible on the same day and return to the usual schedule the following day. The patient should not take two doses on the same day.
5 If the patient vomits after taking VANFLYTA, the patient should not take an additional dose that day but take the next dose the following day at the usual time. Special populations Elderly No dose adjustment is required in the elderly.
Hepatic impairment No dose adjustment is recommended for patients with mild or moderate hepatic impairment. VANFLYTA is not recommended for use in patients with severe […]