PERIPHERAL NEUROPATHY IN THE MPACT STUDY

  • 54% of patients experienced peripheral neuropathy of any grade (227/421)
  • In the 17% of patients who experienced Grade 3 peripheral neuropathy (70/421), 44% (n=31) resumed ABRAXANE at a reduced dose
    • The median time to first occurrence of Grade 3 peripheral neuropathy in the ABRAXANE arm was 140 days
    • The median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days after withholding dose
  • 8% of patients who received ABRAXANE + gemcitabine permanently discontinued ABRAXANE due to peripheral neuropathy

APPROPRIATE DOSE MODIFICATIONS FOR PERIPHERAL NEUROPATHY

Assessing the severity of peripheral neuropathy is key to determining dose modifications
No recommended for Dose modification of ABRAXANE for peripheral neuropathy: Grade 1 or 2 No recommended for Dose modification of ABRAXANE for peripheral neuropathy: Grade 1 or 2
ABRAXANE Dose modification for peripheral neuropathy: Grade ≥3 ABRAXANE Dose modification for peripheral neuropathy: Grade ≥3
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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRAXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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