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APO-DASATINIB is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Clinical effectiveness of dasatinib treatment in patients with newly diagnosed Ph+ CML in chronic phase is based on confirmed complete cytogenetic response rate (cCCyR) within 12 months. As of the 60 month cut-off date, overall survival, prevention of progression to advanced stage CML, or time-in cCCyR benefits have not been demonstrated.
APO-DASATINIB is indicated for the treatment of adults with Ph+ chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate. Clinical effectiveness of dasatinib in CML is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimum of 24 months of follow-up.
APO-DASATINIB is indicated for the treatment of adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Clinical effectiveness in Ph+ ALL is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimum of 24 months of follow-up.
APO-DASATINIB should only be prescribed by a qualified physician who is experienced in the use of antineoplastic therapy.
Geriatrics (≥65 years of age): While the safety profile of dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse events diarrhea, fatigue, cough, pleural effusion, dyspnea, dizziness, peripheral edema, pneumonia, hypertension, arrhythmia, congestive heart failure, pericardial effusion, lower gastrointestinal hemorrhage, abdominal distension and more likely to experience the less frequently reported events pulmonary edema, lung infiltration, arthritis, and urinary frequency and should be monitored closely. No differences in cCCyR and MMR were observed between older and younger patients. However, in the two randomized studies in patients with imatinib resistant or intolerant chronic phase CML, the rates of major cytogenetic response (MCyR) at 2 years were lower among patients aged 65 years and older (42% MCyR in patients ≥65 years versus 56% MCyR in the rest of the study population and 47% MCyR in patients ≥65 years versus 68% MCyR in the rest of the study population in studies CA180017 and CA180034, respectively).
Pediatrics (<18 years of age): The safety and efficacy of dasatinib in patients <18 years of age have not been established. Nonclinical studies demonstrated greater toxicity in rat pups (see Use in Children under Precautions).
