AIM FOR THE RESULTS ACHIEVED IN THE MPACT STUDY:
START PATIENTS AT 125 mg/m2 GIVEN QW3/4

Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study
In the MPACT study1:
  • 41% had at least one ABRAXANE dose reduction
  • 71% had at least one ABRAXANE dose withheld or delayed
Dosing recommendations:
  • Administer ABRAXANE followed by gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
  • ABRAXANE is administered intravenously over 30-40 minutes
Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

  • aAccording to NCCN Chemotherapy Order Templates: peer-reviewed statements of consensus of its authors derived from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
    • 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)
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    • MPACT Modifications Timing

      UNDERSTANDING TIMING OF DOSE MODIFICATIONS
      DURING ABRAXANE + GEMCITABINE THERAPY11
      UNDERSTANDING TIMING OF DOSE MODIFICATIONS DURING ABRAXANE + GEMCITABINE
      THERAPY
      11

      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 cycle11a Percentage of ABRAXANE patients
      receiving 125 mg/m2 at the start of each treatment cycle11a
      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)1
      • 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 ABRXANE 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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