Banplita Tablet 26.5 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 (CR) or complete remission with incomplete hematologic recovery (CRi), 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, which reflects the electrical activity of the heart. Prolongation of the QT interval may increase the risk of potentially dangerous arrhythmias. Therefore, special caution is required when administering this drug to patients with heart disease or electrolyte imbalances. An electrocardiogram (ECG) should be performed before administration to check the QT interval, and treatment should not be initiated if abnormalities are present. Additionally, ECG monitoring should be conducted regularly during treatment to closely observe heart status. This drug may harm the fetus during pregnancy; therefore, women of childbearing potential should use effective contraception during and for a certain period after taking this drug. Men should also take care to prevent their partners from becoming pregnant during and for a certain period after taking this drug. This drug is not recommended for patients with severely impaired liver or kidney function. This drug may interact with other medications, therefore consultation with a physician is necessary, particularly when taken with medications that affect the heart or inhibit or induce specific enzymes. During treatment with this drug, diarrhea or vomiting may lead to electrolyte imbalances; therefore, electrolyte and ECG monitoring should be performed more frequently when such symptoms occur. Adverse effects such as infections, bleeding, gastrointestinal symptoms, and headaches may occur during treatment; thus, any unusual symptoms should be reported to healthcare personnel immediately. The safety and efficacy of this drug have not been established in children or adolescents under the age of 18, and it should not be used in this population. Older adults may also be at higher risk for infections, requiring careful observation during the initial treatment period. This drug should be kept out of reach of children and should not be transferred to other containers.

• Tachycardia
• ventricular fibrillation
• cardiac arrest
• increased alanine aminotransferase
• decreased platelet count
• decreased hemoglobin
• diarrhea
• nausea
• abdominal pain
• headache

This drug may be sensitive to air or moisture; therefore, it must be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the effectiveness of the medication.

Appearance

Yellow round film-coated tablet

Package unit

56 tablets/box [14 tablets/PTP x 4]