Banplitaz Tablet 17.7 mg (Quizartinib Hydrochloride)

Adult dose

This drug is administered in combination with standard chemotherapy at a dose of 35.4 mg once daily for 2 weeks during each induction cycle. For patients who achieve complete remission or complete remission with incomplete hematologic recovery, administer 35.4 mg once daily for 2 weeks during each consolidation chemotherapy cycle. Maintenance therapy is initiated at 26.5 mg once daily once the absolute neutrophil count and platelet count have recovered to >500/㎣ and >50,000/㎣, respectively, after consolidation chemotherapy. After 2 weeks, if QTcF is 450 ms or less, increase the maintenance dose to 53 mg once daily. Maintenance therapy may be continued for up to 36 cycles. This drug should be taken orally at approximately the same time each day and may be taken with food or on an empty stomach. Swallow this drug whole; do not chew, crush, or divide it.

This drug may prolong the QT interval, indicating potential electrical activity changes in the heart. Prolonged QT interval can lead to serious cardiac issues such as dangerous arrhythmias, ventricular fibrillation, cardiac arrest, or sudden death. ECG monitoring of the QT interval should be performed regularly before and during treatment with this drug. Patients with underlying heart disease or electrolyte imbalance (especially low potassium and magnesium levels) should use this drug with caution. Additional caution is warranted if this drug is taken concurrently with other medications that also prolong the QT interval. This drug can interact with certain enzymes (CYP3A), which may require dosage adjustment when taken together. Pregnant women or women planning to become pregnant should avoid this drug due to potential harm to the fetus and must ensure effective contraception during and for a period after treatment. This drug is indicated for the treatment of leukemia and should only be administered to patients with specific genetic mutations to achieve therapeutic effect. Side effects may include decreased blood cell counts, gastrointestinal symptoms (diarrhea, nausea, vomiting), liver function abnormalities, headache, and increased infection risk. Patients should consult healthcare professionals immediately if abnormal symptoms occur while taking this drug, especially if any cardiac-related symptoms or ECG abnormalities are observed. Safety and efficacy have not been established in children, and it is not recommended for elderly patients or those with severely compromised renal and hepatic function. This drug should be kept out of the reach of children and should not be transferred to other containers.

• ventricular tachycardia
• ventricular fibrillation
• cardiac arrest
• sudden death
• increased alanine aminotransferase
• decreased platelet count
• decreased hemoglobin
• diarrhea
• nausea
• abdominal pain

This drug should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1°C and 30°C.

Appearance

White round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]