Label Changes for:
Sprycel (dasatinib) Tablets
October 2011
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
October 2011
ADVERSE REACTIONS
Postmarketing Experience
- pulmonary arterial hypertension
October 2010
WARNINGS and PRECAUTIONS
Congestive Heart Failure, Left Ventricular Dysfunction, and Myocardial Infarction
- Cardiac adverse reactions were reported in 5.8% of 258 patients taking Sprycel, including 1.6% of patients with cardiomyopathy, heart failure congestive, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction. Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.
July 2010
Dose Adjustment for Adverse Reactions
Myelosuppression
- 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 resistant myelosuppression. Guidelines for dose modifications are summarized in Table 1.
(revision of the Adverse Reactions section of the package insert to include discontinuation rate due to myelosuppression to 5%)
