Quizartinib Application Scope

Quizartinib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3-ITD mutation. It may also be considered in other FLT3-positive AML contexts as per clinical guidelines.

Quizartinib Characteristics

Ingredients: Quizartinib
Properties: A kinase inhibitor that specifically targets and blocks the action of the FLT3 (FMS-like tyrosine kinase 3) enzyme, which is overactive due to the FLT3-ITD mutation and drives the growth of AML cells.
Packaging Specification: 17.7 mg & 26.5 mg × 28 tablets.
Storage: Store at $20 - 2 5^{\circ} C$
Expiry Date: As indicated on the packaging.
Executive Standard: As indicated on the packaging.
Approval Number: As indicated on the packaging.
Date of Revision: As indicated on the packaging.
Manufacturer: Daiichi Sankyo, Inc.

Guidelines for the Use of Quizartinib

Dosage and Administration:
- Recommended Dose:
  - Induction: 35.4 mg orally once daily on Days 8-21 (up to 2 cycles).
  - Consolidation: 35.4 mg orally once daily on Days 6-19 (up to 4 cycles).
  - Maintenance: 26.5 mg once daily for Days 1-14 of Cycle 1, then 53 mg once daily from Day 15 if QTcF ≤450 ms (up to 36 cycles).
- Administration: Take once daily, at approximately the same time, with or without food. Swallow tablets whole.
- Missed Dose: If a dose is missed or not taken at the usual time, administer it as soon as possible on the same day and return to the usual schedule the following day. Do not administer two doses on the same day. If a dose is vomited, do not administer a replacement dose; wait until the next scheduled dose is due.
Adverse Reactions:
- Common Adverse Reactions: Decreased lymphocytes, decreased potassium, decreased albumin, decreased phosphorus, increased alkaline phosphatase, decreased magnesium, febrile neutropenia, diarrhea, mucositis, nausea, decreased calcium, abdominal pain, sepsis, neutropenia, headache, increased creatine phosphokinase, vomiting, and upper respiratory tract infection.
- Serious Adverse Reactions:
  - QT Prolongation, Torsades de Pointes, and Cardiac Arrest: Can prolong the QT interval; serious and fatal cardiac arrhythmias have occurred, predominantly during the induction phase.
  - Sepsis, Fungal Infections, Febrile Neutropenia, Brain Edema.
Contraindications: Severe hypokalemia, severe hypomagnesemia, long QT syndrome, history of ventricular arrhythmias or torsades de pointes.
Precautions:
- QT Prolongation, Torsades de Pointes, Cardiac Arrest: Prolongs QT in dose-dependent manner; risk of serious arrhythmias. Avoid in high-risk patients (e.g., recent MI, heart failure). Monitor ECG weekly during induction/consolidation, initially weekly in maintenance. Correct electrolytes. Dose adjust/interrupt for QTcF >450 ms. Available only via VANFLYTA REMS (prescribers/pharmacies certified, patient counseling on risks).
- Embryo-Fetal Toxicity: May cause fetal harm; advise on contraception (females: during and 7 months after; males: during and 4 months after). Other: Monitor for hypokalemia/hypomagnesemia, diarrhea/vomiting. Avoid in uncontrolled cardiac disease.

Quizartinib Interactions

Strong CYP3A Inhibitors: Increase quizartinib exposure; reduce VANFLYTA dose (induction/consolidation: 26.5 mg; maintenance: 26.5-35.4 mg).
Strong or Moderate CYP3A Inducers: Decrease exposure; avoid coadministration.
QT-Prolonging Drugs: Increase arrhythmia risk; monitor ECG/electrolytes more frequently.
Sensitive CYP3A Substrates: Quizartinib decreases exposure of substrates (e.g., hormonal contraceptives); use alternatives.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.