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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Date:11/8/2007

r ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving SPRYCEL.

Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump inhibitors (e.g., famotidine and omeprazole) is likely to reduce dasatinib exposure. Therefore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. The use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of SPRYCEL.

Pregnancy:

SPRYCEL may 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.

Nursing Mothers:

It is unknown whether SPRYCEL is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue drug.

Adverse Reactions:

The safety data reflect exposure to SPRYCEL in 2,182 patients with leukemia in clinical studies (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily). The majority of SPRYCEL- treated patients experienced adverse reactions at some time. Drug was discontinued for adverse reactions in 9% of patients in chronic phase, 10% in accelerated phase, 15% in myeloid blast phase CML, and 8% in lymphoid blast phase CML or Ph+ ALL.

The most frequently reported adverse reactions (reported in greater than or equal to 20% of patients) included fluid retention events (37%), diarrhea (31%), headache (24%), skin rash (22%), nausea (22%), hemorrhage (21%), fatigue (21%), and dyspnea (20%).

The most frequently reported serious adverse reactions included pleural effusion (9%), pyrexia (3%), pneumonia (3%), infection (2%), febrile neutropenia (4%), gast
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SOURCE Bristol-Myers Squibb Company
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