FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Bre... (mm(3) or a platelet count HYPER...)

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FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer

Date:10/16/2007

mm(3) or a platelet

count <100,000 cells/mm(3).

HYPERSENSITIVITY REACTION

Premedicate with an H1 and an H2 antagonist approximately 1 hour before IXEMPRA infusion and observe for hypersensitivity reactions (e.g., flushing, rash, dyspnea, and bronchospasm).

In case of severe hypersensitivity reactions, infusion of IXEMPRA should be stopped and aggressive supportive treatment (e.g., epinephrine, corticosteroids) started.

Patients who experience a hypersensitivity reaction in one cycle of IXEMPRA must be premedicated in subsequent cycles with a corticosteroid in addition to the H1 and H2 antagonists, and extension of the infusion time should be considered.

MYELOSUPPRESSION

Patients should be monitored for myelosuppression; frequent peripheral blood cell counts are recommended for all patients receiving IXEMPRA.

Patients who experience severe neutropenia or thrombocytopenia should have their dose reduced. Neutropenia related deaths occurred in patients administered IXEMPRA and capecitabine (1.9% of 414 patients) and IXEMPRA alone (0.4% in 240 patients).

PERIPHERAL NEUROPATHY

Patients treated with IXEMPRA should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain. Patients experiencing new or worsening peripheral neuropathy may require changes in the dose or discontinuation of IXEMPRA. Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity. Caution should be used when treating patients with diabetes mellitus or existing moderate to severe neuropathy.

PREGNANCY

Women should be advised not to become pregnant when taking IXEMPRA. If this drug is used during pregnancy or the patient becomes pregnant, the patient should be apprised of the potential hazard to the fetus.

CARDIAC ADVERSE REACTIONS

Caution should be exercised in patients with a history of cardiac disease. D
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FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Bre...(mm(3) or a platelet count HYPER...)