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Sanofi-aventis Oncology Data to be Presented at San Antonio Breast Cancer Symposium
Date:12/9/2010

de 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death
  • Patients with isolated elevations of transaminase > 1.5 X ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death
  • Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy

  • Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3
  • In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®

  • Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication
  • Hypersensitivity reactions require immediate discontinuation of Taxotere® infusion and administration of appropriate therapy

  • Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80

  • Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).

  • Neutropenia (<2,000 neutrophils/mm3) occurs in virtually all patients given 60-100 mg/m2 of Taxotere® and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2

  • Patients should be premedicated with oral cortico
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