A WELL-ESTABLISHED SAFETY PROFILE

Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE + gemcitabine arm
In the MPACT study, most common adverse reactions (≥20%) with a ≥5% higher incidence for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)/gemcitabine arm vs gemcitabine alone were neutropenia (73% vs 58%), fatigue (59% vs 46%), peripheral neuropathy (54% vs 13%), nausea (54% vs 48%), alopecia (50% vs 5%), peripheral edema (46% vs 30%), diarrhea (44% vs 24%), pyrexia (41% vs 28%), vomiting (36% vs 28%), decreased appetite (36% vs 26%), rash (30% vs 11%), and dehydration (21% vs 11%) - table In the MPACT study, most common adverse reactions (≥20%) with a ≥5% higher incidence for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)/gemcitabine arm vs gemcitabine alone were neutropenia (73% vs 58%), fatigue (59% vs 46%), peripheral neuropathy (54% vs 13%), nausea (54% vs 48%), alopecia (50% vs 5%), peripheral edema (46% vs 30%), diarrhea (44% vs 24%), pyrexia (41% vs 28%), vomiting (36% vs 28%), decreased appetite (36% vs 26%), rash (30% vs 11%), and dehydration (21% vs 11%) - table
  • ABRAXANE + gemcitabine had the same incidence of death due to adverse reactions compared to gemcitabine alone (4% of patients in each arm)4
  • Disease progression was the most common reason for treatment discontinuation4
  • The most common ARs resulting in permanent discontinuation of ABRAXANE were:
    8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia
    The most common ARs resulting in permanent discontinuation of ABRAXANE were: 8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia
  • Selected Adverse Reactions

    A WELL-ESTABLISHED SAFETY PROFILE

    Higher incidence (≥5% for all grade toxicity or ≥2% Grade 3 or higher toxicity)
    in the ABRAXANE + gemcitabine arm
    • MedDRA=Medical Dictionary for Regulatory Activities.
    • a405 patients assessed in ABRAXANE + gemcitabine–treated group.
    • b388 patients assessed in gemcitabine-treated group.
    • c404 patients assessed in ABRAXANE + gemcitabine–treated group.
    • dNeutrophil growth factors were administered to 26% of patients in the ABRAXANE + gemcitabine group.
    • ePeripheral neuropathy is defined by the MedDRA v15.0 Standardized MedDRA Query (broad scope).
    • fUrinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococcal.
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  • Most Serious Adverse Reactions

    A WELL-ESTABLISHED SAFETY PROFILE

    Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE + gemcitabine arm Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE
    + gemcitabine arm
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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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