DOSING THAT DELIVERS

A well-established regimen for your patients

  • Starting dose of 125 mg/m2
  • Administer ABRAXANE, followed by gemcitabine 1000 mg/m2, on Days 1, 8, and 15 of each 28-day cycle
  • 30- to 40-minute IV infusion

A WELL-DEFINED DOSE MODIFICATION SCHEDULE

Dose level reductions for patients with mPC
In the MPACT study4
  • 41% of patients had at least one ABRAXANE dose reduction
  • 71% of patients had at least one ABRAXANE dose withheld or delayed
  • Use in Patients With Hepatic Impairment

    STARTING DOSE FOR PATIENTS
    WITH HEPATIC IMPAIRMENT

    Starting Dose for Patients with Mild Hepatic Impairment Starting Dose for Patients with Mild Hepatic Impairment
    • Patients with bilirubin levels above the ULN were excluded from the MPACT study (central lab ULN in the MPACT study was 1.5 mg/dL)
    • AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase.
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  • MPACT Modifications Timing

    UNDERSTANDING TIMING OF DOSE MODIFICATIONS
    DURING ABRAXANE + GEMCITABINE THERAPY9
    UNDERSTANDING TIMING OF DOSE MODIFICATIONS DURING ABRAXANE + GEMCITABINE
    THERAPY
    9

    ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer
    • a First 2 cycles.
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  • % of ABRAXANE Patients Receiving 125 mg/m2 at the Start of Each Treatment Cycle

    THE APPROVED STARTING DOSE OF 125 mg/m2

    Percentage of ABRAXANE patients receiving 125 mg/m2 at the start of each treatment cycle9,a Percentage of ABRAXANE patients receiving 125 mg/m2 at the start of each treatment cycle9,a
    Percentage MPAC patients receiving the ABRAXANE starting dose of 125mg/m2 at the start of each treatment cycles (Cycles 1-5) Percentage MPAC patients receiving the ABRAXANE starting dose of 125mg/m2 at the start of each treatment cycles (Cycles 1-5)
    • Median duration of treatment: 3.9 months (range 0.1 to 21.9 months)3
    • aWithin the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications are not shown here. aWithin the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications are not shown here.
    • bCycle 1=8 weeks; subsequent cycles=4 weeks each.
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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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