Quizartinib

This drug is used in combination with standard cytarabine and anthracycline drugs for induction and cytarabine consolidation therapy, and as a maintenance monotherapy after consolidation chemotherapy.

During the use of quizartinib, the patient's electrolyte levels, electrocardiogram, and potential adverse reactions should be closely monitored, and dosage adjustments or discontinuation should be made as needed.

1.Main components

quizartinib

2.Adapt to the population

Patients with relapsed or refractory FLT3-ITD mutation positive acute myeloid leukemia.

3.Medication for special populations

3.1Pregnancy

Based on findings from animal studies and its mechanism of action, quizartinib can cause embryo-fetal harm when administered to a pregnant woman.

3.2Lactation

There are no data on the presence of quizartinib or its metabolites in human milk, or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with quizartinib and for one month after the last dose.

3.3Females and Males of Reproductive Potential

quizartinib can cause embryo-fetal harm when administered to pregnant women.

3.4Geriatric Us

There were 533 patients with newly diagnosed AML in the clinical study; of the total number of quizartinib-treated patients, 69 (26%) were 65 years of age and older, while 1 (0.4%) was 75 years of age [see Clinical Studies (14)]. No overall differences in safety or efficacy were observed between patients 65 years of age and older and younger adult patients.

3.5Pediatric Use

Safety and effectiveness of quizartinib have not been established in pediatric patients.

3.6Patients with renal impairment

No dosage adjustment is recommended in patients with mild to moderate renal impairment (i.e., estimated creatinine clearance [CLcr] by Cockcroft-Gault equation: CLcr 30 to 89 mL/min). quizartinib has not been studied in patients with severe renal impairment (CLcr <30 mL/min).

3.7Patients with liver damage

No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Class A or total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1 to 1.5 times ULN and any value for AST) or moderate hepatic impairment (Child-Pugh Class B or total bilirubin >1.5 to 3 times ULN and any value for AST). quizartinib has not been studied in patients with severe (Child-Pugh Class C or total bilirubin >3 times ULN and any value for AST) hepatic impairment.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

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

6.Pharmacokinetics

The pharmacokinetics of quizartinib and its major circulating active metabolite (AC886) were characterized in healthy subjects and in patients with cancer and are presented as geometric mean (percent coefficient of variation [%CV]) unless otherwise specified.

from FDA，2023.07