Product Name: LuciQuiza

Chinese Name: Quizartinib

English Name: Quizartinib

Specifications: 17.7 mg/tablet, 14 tablets/bottle; 26.5 mg/tablet, 14 tablets/bottle

[Overview]

Quizartinib is a novel oral targeted agent directed against the FLT3 ligand. It selectively and effectively inhibits FLT3-ITD tyrosine kinase, which acts as a growth driver for the abnormal cells responsible for the development of AML. In patients with relapsed/refractory AML harboring FLT3-ITD mutations, it is the first FLT3 inhibitor to demonstrate superiority over chemotherapy in terms of overall survival.

[Indications]

Indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are positive for FLT3 internal tandem duplication (ITD), as detected by an FDA-approved test method. It may be used in combination with cytarabine and an anthracycline during induction therapy, and as a single agent for maintenance therapy following consolidation chemotherapy.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

[Dosage and Administration]

1. For recommended dosages and dose adjustment schedules for Quizartinib, please refer to the full Prescribing Information.

2. Administer orally once daily, at approximately the same time each day, with or without food.

[Adverse Reactions]

The most common (>20%) adverse reactions include laboratory abnormalities—specifically lymphopenia, hypokalemia, hypoalbuminemia, hypophosphatemia, increased alkaline phosphatase, hypomagnesemia—as well as febrile neutropenia, diarrhea, mucositis, nausea, hypocalcemia, abdominal pain, sepsis, neutropenia, headache, increased creatine phosphokinase, vomiting, and upper respiratory tract infection. [Contraindications]

Contraindicated in patients with severe hypokalemia, severe hypomagnesemia, Long QT Syndrome, or a history of ventricular arrhythmias or Torsades de Pointes.

[Warnings and Precautions]

QT Interval Prolongation, Torsades de Pointes, and Sudden Cardiac Death: Monitor ECG and serum electrolyte levels. Reduce, interrupt, or permanently discontinue quizartinib as appropriate.

Embryo-Fetal Toxicity: Quizartinib can cause fetal harm. Advise females of reproductive potential, and males with female partners of reproductive potential, of the potential risk to the fetus and to use effective contraception.

[Drug Interactions]

Strong CYP3A Inhibitors: Reduce the dose of LuciQuiza.

Strong or Moderate CYP3A Inducers: Avoid concomitant use.

[Use in Specific Populations]

Lactation: Advise against breastfeeding.

Pregnancy: LuciQuiza can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus.

Pediatric Use: The safety and effectiveness of LuciQuiza in pediatric patients have not been established.

Geriatric Use: No overall differences in safety or efficacy were observed between patients aged 65 and older compared to younger adult patients.

Renal Impairment: No dose adjustment is recommended for patients with mild to moderate renal impairment (CLcr 30 to 89 mL/min). LuciQuiza has not been studied in patients with severe renal impairment (CLcr <30 mL/min).

Hepatic Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment. LuciQuiza has not been studied in patients with severe hepatic impairment.