Sprycel 50 mg (Dasatinib)

Adult dose

The recommended starting dose of this medication for chronic-phase chronic myeloid leukemia is 100mg orally once daily. The recommended starting dose for accelerated-phase or myeloid or lymphoid blast-phase chronic myeloid leukemia, and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is 140mg orally once daily. This medication may be taken in the morning or evening, with or without food. Consider reducing the dose if this medication must be administered with a strong CYP3A4 inhibitor. Patients receiving 140mg of this medication once daily: 40mg once daily Patients receiving 100mg of this medication once daily: 20mg once daily Patients receiving 70mg of this medication once daily: 20mg once daily For patients receiving 60mg or 40mg of this medication once daily, consider interrupting this medication until the CYP3A4 inhibitor is discontinued. In clinical studies in adults with chronic myeloid leukemia (CML) and patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), for patients who did not achieve a hematologic or cytogenetic response at the recommended starting dose, dose escalation up to 140mg once daily (for patients with chronic-phase CML) or 180mg once daily (for patients with accelerated-phase or blast-phase CML and patients with Philadelphia chromosome-positive acute lymphoblastic leukemia) was permitted. Dose adjustment for neutropenia and thrombocytopenia in adults Chronic-phase chronic myeloid leukemia (chronic phase CML): Start treatment at a dose of 100mg once daily. Absolute neutrophil count less than 0.5 x 109/L or platelet count less than 50 x 109/L: Interrupt treatment with this medication until the absolute neutrophil count is at least 1.0 x 109/L and the platelet count is at least 50 x 109/L. If recovery occurs within 7 days or less, resume treatment with this medication at the starting dose. If a platelet count less than 25 x 109/L or an absolute neutrophil count less than 0.5 x 109/L for more than 7 days recurs, repeat step 1; upon the second recurrence, resume at a reduced dose of 80mg once daily. Upon the third recurrence, further reduce the dose to 50mg once daily for newly diagnosed patients, and discontinue this medication for patients who are resistant or intolerant to prior therapy, including imatinib. Accelerated-phase or blast-phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia: Start treatment at a dose of 140mg once daily. Absolute neutrophil count less than 0.5 x 109/L or platelet count less than 10 x 109/L: Determine whether the cytopenia is associated with leukemia (bone marrow aspiration or biopsy). If the cytopenia is not related to leukemia, interrupt treatment with this medication until the absolute neutrophil count is at least 1.0 x 109/L and the platelet count is at least 20 x 109/L, then resume treatment at the starting dose. If the cytopenia recurs, repeat step 1; upon the second recurrence, resume treatment with this medication at a reduced dose of 100mg once daily, and upon the third recurrence, at a reduced dose of 80mg once daily. If the cytopenia is related to leukemia, increase the dose to 180mg once daily. In adult patients with Ph+ CML and ALL, if serious nonhematologic adverse reactions occur with this medication, treatment should be withheld until the reaction resolves or improves. Treatment may then be resumed at a reduced dose, as appropriate, depending on the symptoms and recurrence of the reaction. In clinical studies, treatment with this medication in adults and pediatric patients with chronic-phase CML continued until disease progression or intolerance occurred.

Child dose

In children, the recommended initial dose is based on body weight. This drug is administered orally once daily, with or without food. The dose should be recalculated every 3 months or more frequently as needed based on changes in body weight. It is not recommended for patients weighing less than 10kg. 10kg to less than 20kg: daily dose 40mg 20kg to less than 30kg: daily dose 60mg 30kg to less than 45kg: daily dose 70mg 45kg or more: daily dose 100mg For pediatric patients with CML who do not achieve a hematologic or cytogenetic response with the recommended initial dose, the following dose increases are recommended. Initial dose 40mg: increased dose 70mg Initial dose 50mg: increased dose 90mg Initial dose 60mg: increased dose 100mg Initial dose 70mg: increased dose 120mg When this drug is administered in combination with chemotherapy to pediatric patients with Ph+ ALL, dose escalation of this drug is not recommended. Dose adjustment for neutropenia and thrombocytopenia in pediatric patients with chronic-phase CML Starting dose 40mg: 1st dose reduction 20mg; 2nd dose reduction ** Starting dose 60mg: 1st dose reduction 40mg; 2nd dose reduction 20mg Starting dose 70mg: 1st dose reduction 60mg; 2nd dose reduction 50mg Starting dose 100mg: 1st dose reduction 80mg; 2nd dose reduction 70mg If cytopenia persists for more than 3 weeks, determine whether the cytopenia is related to leukemia (bone marrow aspiration or biopsy). If the cytopenia is not related to leukemia, interrupt this drug until ANC*≥1.0× 109/L and platelets are ≥75× 109/L, then resume treatment at the starting dose or a reduced dose. If cytopenia recurs, repeat bone marrow aspiration/biopsy and resume treatment with this drug at a reduced dose. **Lower-strength tablets are not available In pediatric patients with chronic-phase CML, if grade 3 or higher neutropenia or thrombocytopenia recurs during complete hematologic response (CHR), treatment with this drug should be interrupted and may subsequently be resumed at a reduced dose. Temporary dose reductions may be made as needed for moderate cytopenia and disease response. In pediatric patients with ALL, if the next treatment block is delayed for more than 14 days due to neutropenia or thrombocytopenia, this drug should be interrupted and resumed at the same dose when the next treatment block begins. If neutropenia or thrombocytopenia persists and the next treatment block is delayed by an additional 7 days, a bone marrow examination should be performed to assess cellularity and the percentage of blasts. If bone marrow cellularity is less than 10%, treatment with this drug should be interrupted until the absolute neutrophil count exceeds 500/μL(0.5 x 109/L), and may be resumed at the normal dose when treatment is restarted. If bone marrow cellularity is greater than 10%, resumption of treatment with this drug may be considered. In pediatric patients with Ph+ CML, if serious nonhematologic adverse reactions occur with this drug, treatment should be withheld until the reaction resolves or improves. Treatment may then be resumed at a reduced dose, as appropriate, depending on the signs of the reaction and whether it recurs. For pediatric patients with Ph+ ALL, refer to the following for dose adjustment in the event of grade 2 nonhematologic toxicity. If a grade 3 or higher nonhematologic adverse reaction occurs, excluding abnormal liver function tests, interrupt treatment and resume at a reduced dose once the adverse reaction resolves to grade 1 or lower. If direct bilirubin increases to more than 5 times the upper limit of normal (ULN), interrupt treatment until the level returns to baseline or below grade 1. If AST/ALT increases to more than 15 times the ULN, interrupt treatment until the level returns to baseline or below grade 1. If the above abnormalities in liver function tests recur, reduce the dose of this drug if the adverse reaction recurs after retreatment with this drug. Dose adjustment for nonhematologic adverse reactions in pediatric patients Starting dose 40mg: 1st dose reduction 20mg; 2nd dose reduction ** Starting dose 60mg: 1st dose reduction 40mg; 2nd dose reduction 20mg Starting dose 70mg: 1st dose reduction 60mg; 2nd dose reduction 50mg Starting dose 100mg: 1st dose reduction 80mg; 2nd dose reduction 70mg If grade 2 nonhematologic toxicity occurs and does not resolve despite treatment of symptoms, consider interrupting this drug. Once the adverse reaction resolves to grade 1 or lower, resume treatment at the starting dose. For a recurrent adverse reaction, resume treatment at a reduced dose. If grade 3 nonhematologic toxicity occurs, interrupt this drug until it resolves to grade 1 or lower, then resume at a reduced dose. If direct bilirubin increases to more than 5 times the upper limit of normal or AST/ALT increases to more than 15 times the upper limit of normal, interrupt this drug until it resolves to below grade 1, then resume at the starting dose. For a recurrent adverse reaction, resume treatment at a reduced dose. **Lower-strength tablets are not available In pediatric patients with Ph+ ALL, treatment with this drug is initiated on or before day 15 of induction chemotherapy. In clinical studies, treatment with this drug in pediatric patients with Ph+ ALL, in addition to the backbone chemotherapy, continued for up to 2 years after confirmation of diagnosis.

This drug can cause serious harm to a fetus if taken during pregnancy, so it should not be taken by pregnant women. Women who may become pregnant must avoid pregnancy while taking this drug, and if pregnancy is confirmed, they should immediately consult a healthcare provider. Patients allergic to any components of this drug or those with genetic lactose intolerance should not take this medication. Patients taking medications that affect blood coagulation should be cautious, as there is a risk of bleeding when using this drug. Patients with heart disease or symptoms of QT interval prolongation, or electrolyte imbalances such as hypokalemia or hypomagnesemia should correct their condition and take this medication with caution. Patients with impaired liver function should be carefully monitored as this drug is metabolized in the liver. This drug may exacerbate pulmonary arterial hypertension; if symptoms like shortness of breath or fatigue occur, notify your healthcare provider immediately. Hepatitis B carriers should closely monitor for any exacerbation of hepatitis before and during treatment with this drug. Due to myelosuppression, blood cell counts may decrease, so regular blood tests are required, and dosage adjustment or discontinuation may be necessary if symptoms are severe. Side effects such as fluid retention and pleural or pericardial effusions may occur, so if symptoms like shortness of breath or swelling appear, immediate diagnosis and treatment are necessary. Patients with a history of heart disease should carefully monitor their cardiac condition as heart function abnormalities, arrhythmias, and heart failure have been reported. Severe skin reactions may occur, so immediate consultation with a healthcare provider is necessary if rash or skin abnormalities arise. This drug has many drug interactions; therefore, it is essential to inform healthcare providers about any other medications being taken. Special caution is required when used with CYP3A4 inhibitors or inducers, antacids, H2 blockers, and proton pump inhibitors. In pediatric patients, it may affect bone growth and development; thus, growth should be monitored periodically. In elderly patients, side effects such as fatigue, shortness of breath, and bleeding may occur more frequently, requiring closer observation. Overdose can lead to severe myelosuppression and cardiotoxicity, so it is crucial to adhere strictly to the recommended dosage, and immediate medical attention should be sought in cases of overdose. This medication should be stored at room temperature between 15-30°C and gloves should be worn when handling broken or damaged tablets to avoid skin exposure. Pregnant women should take special care to avoid exposure to broken tablets.

• Bone marrow suppression
• hemorrhage
• fluid retention
• QT prolongation
• severe skin reactions
• congestive heart failure
• left ventricular dysfunction
• myocardial infarction
• pulmonary hypertension
• effects on growth and development

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. The appropriate storage temperature is between 15 and 30 degrees Celsius. By following these conditions, the effectiveness of the medication can be maintained for a longer time.

Appearance

White to grayish-white, oval, biconvex film-coated tablet, engraved with 'BMS' on one side and '528' on the other side.

Package unit

60 tablets/PTP