FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic... (ith SPRYCEL(R) (dasatinib) is associated...)

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Date:11/8/2007

ith SPRYCEL(R) (dasatinib) is associated with severe CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. Their occurrence is more frequent in advanced phase CML or Ph+ ALL than in chronic-phase CML. Myelosuppression was reported in patients with normal baseline laboratory values, as well as in patients with pre-existing laboratory abnormalities. Complete blood counts (CBCs) should be performed weekly for the first 2 months and then monthly thereafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with persistent myelosuppression.

Bleeding Events:

Dasatinib caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe CNS hemorrhage, including fatalities, occurred in <1% of patients. Severe GI hemorrhage occurred in 4% of patients and generally required treatment interruptions and transfusions. Other cases of severe hemorrhage occurred in 2% of patients. Most bleeding events were associated with severe thrombocytopenia. Caution is advised in patients required to take medications that inhibit platelet function or anticoagulants.

Fluid Retention:

Fluid retention was severe in 8% of patients, including pleural and pericardial effusions reported in 5% and 1%, respectively. Severe ascites and generalized edema were reported in <1% of patients. Severe pulmonary edema was reported in 1% of patients. Patients who develop symptoms suggestive of pleural effusion (dyspnea or dry cough) should be evaluated by chest X-ray. Severe pleural effusion may require oxygen therapy and thoracentesis. Fluid retention was typically managed by supportive care measures that included diuretics or short courses of steroids. Patients over the age of 65 years are more likely to experience fluid retention events, and should be monitored closely.

QT Prolongation:

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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...(ith SPRYCEL(R) (dasatinib) is associated...)