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Important Safety Information

Warning: 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

Contraindications

  • IXEMPRA is also contraindicated in patients:
    • with a known history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives such as polyoxyethylated castor oil
    • who have a baseline neutrophil count <1500 cells/mm3 or a platelet count <100,000 cells/mm3

Cremophor is a registered trademark of BASF AG.

  1. AST = aspartate aminotransferase
  2. ALT = alanine aminotransferase
  3. ULN = upper limit of normal
  4. CTC = common terminology criteria

Please see complete Important Safety Information, including Boxed WARNING regarding hepatic impairment.

IXEMPRA ®(ixabepilone) is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

IXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

  • Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting
  • Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting

Medical Information Support

Healthcare professionals can contact the Medical Information organization for additional professional and/or medical resources by clicking here
 

http://www.ixempra.com

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