奎扎替尼26.5mg 适用于治疗经FDA批准的测试方法检 测为FLT3内串联重复（ITD）阳性的新诊断急性髓系白血病（AML）成年患者。在诱 导治疗中可与阿糖胞苷和蒽环类联合使用，单药可用于巩固化疗后的维持治疗。

LuciQuiza Tablets Simple Instructions

Please use under the guidance of a physician

Product Name: LuciQuiza

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Quizartinib tablets

English name: Quizartinib tablets

Drug approval number: 06 L 1106/24 (26.5 mg)

 

【Indications】

LuciQuiza is a kinase inhibitor indicated for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation therapy, and as maintenance monotherapy following consolidation chemotherapy, 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.

Restrictions on Use:

LuciQuiza is not indicated for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); use of LuciQuiza in this setting has not been shown to improve overall survival.

 

【Usage and Dosage】

• Take LuciQuiza tablets by mouth once daily at approximately the same time each day, with or without food.

• Refer to the full package insert for LuciQuiza dosing regimen and dose adjustments.

 

【Specification】

26.5mg×30 tablets/box.

 

【 Contraindications 】

It is 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 prolongation, torsade de pointes, and cardiac arrest: Monitor ECG and serum electrolyte levels. Reduce, interrupt, or permanently discontinue LuciQuiza as appropriate.

• Embryo-Fetal Toxicity: LuciQuiza 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.

 

【Adverse Reactions】

The most common (>20%) adverse reactions, including laboratory abnormalities, were lymphocytopenia, potassium decreased, albumin decreased, phosphorus decreased, alkaline phosphatase increased, magnesium decreased, febrile neutropenia, diarrhea, mucositis, nausea, calcium decreased, abdominal pain, sepsis, neutropenia, headache, creatine phosphokinase increased, vomiting, and upper respiratory tract infection.

 

【Drug Interactions】

• Strong CYP3A inhibitors: Reduce LuciQuiza dose.

• Strong or moderate CYP3A inducers: Avoid concomitant use.

 

【Use by specific groups】

Lactation: Breastfeeding is not recommended.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.