FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Bre...(rative treatment-related non-hematologic...)

Date:10/16/2007

rative treatment-related non-hematological adverse events reported in patients treated with capecitabine alone included: peripheral sensory neuropathy 16% (Grade 3/4: 0%), palmar-plantar erythrodysesthesia (hand-foot syndrome) 63% (Grade 3/4: 17%), fatigue/asthenia 29% (Grade 3/4: 4%), nausea 40% (Grade 3/4: 2%), diarrhea 39% (Grade 3/4: 9%), vomiting 24% (Grade 3/4: 2%), myalgia/arthralgia 5% (Grade 3/4: <1%), anorexia 15% (Grade 3/4: 1%), stomatitis/mucositis 20% (Grade 3/4: 3%), alopecia 3% (Grade 3/4: 0%), abdominal pain 14% (Grade 3/4: 1%), nail disorder 10% (Grade 3/4: <1%), musculoskeletal pain 5% (Grade 3/4: 0%), and constipation 6% (Grade 3/4: <1%). Treatment-related hematological adverse events of Grade 3/4 severity reported in patients treated with capecitabine alone included: neutropenia 11% and leukopenia 6%.

IMPORTANT SAFETY INFORMATION

TOXICITY IN HEPATIC IMPAIRMENT

IXEMPRA (ixabepilone) in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death.

In combination with capecitabine, the overall frequency of Grade 3/4 adverse reactions, febrile neutropenia, serious adverse reactions, and toxicity related deaths was greater in patients with hepatic impairment.

Caution should be used when using IXEMPRA as monotherapy in patients with AST or ALT > 5 x ULN. Use of IXEMPRA in patients with AST or ALT > 10 x ULN or bilirubin >3 x ULN is not recommended.

With monotherapy, Grade 4 neutropenia, febrile neutropenia, and serious adverse reactions were more frequent in patients with hepatic impairment.

CONTRAINDICATIONS

IXEMPRA is contraindicated in patients:

* with a known history of a severe (CTC Grade 3/4) hypersensitivity

reaction to agents containing Cremophor(R) EL or its derivatives such as

polyoxyethylated castor oil.

* who have a baseline neutrophil count <1500 cells/
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SOURCE Bristol-Myers Squibb Company Copyright©2007 PR Newswire. All rights reserved

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