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U.S. Department of Health and Human Services

Safety

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Sprycel (dasatinib) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.7 Embryofetal toxicity
  • Advise females of reproductive potential to avoid pregnancy, which may include the use of contraception, during treatment with SPRYCEL, [see Use in Specific Populations (8.8)]

8 USE IN SPECIFIC POPULATIONS

8.8 Females of Reproductive Potential
  • SPRYCEL can cause fetal harm when ....

17 PATIENT COUNSELING INFORMATION 

17.4 Embryo-Fetal Toxicity
  • Patients should be informed that SPRYCEL can cause fetal harm when administered to a pregnant woman. Women should be advised of the potential hazard to the fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, or if the patient becomes pregnant while taking SPRYCEL, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.8).]

 

 

June 2013

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ADVERSE REACTIONS

(Clinical Trials section revised of the package insert to include information from interim follow-up analyses of data coming from the ongoing Phase 3 studies CA180034 (with a minimum of 5 years follow-up) and CA180056 (with a minimum of 3 years follow-up).
  • In the newly diagnosed chronic phase CML trial with a minimum of 36 months follow up and median duration of therapy of 37 months, the median average daily dose was 99 mg.
  • In the imatinib resistant or intolerant CML or Ph+ ALL clinical trials, 1520 patients had a minimum of 2 years follow up and 662 patients with chronic phase CML had a minimum of 60 months follow up (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily). Among patients with chronic phase CML and resistance or intolerance to prior imatinib therapy, the median duration of treatment with Sprycel 100 mg once daily was 37 months (range 1–65 months). The median duration of treatment with...

 

October 2011

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ADVERSE REACTIONS

Postmarketing Experience
  • pulmonary arterial hypertension

 

October 2010

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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

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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%)