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ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
2014-08-27 00:11:06 来源: 作者: 【 】 浏览:373次 评论:0
ABRAXANE (paclitaxel) injection, powder, lyophilized, for suspension
[Abraxis BioScience, LLC]
 

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ABRAXANE safely and effectively. See full prescribing information for ABRAXANE.

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
Initial U.S. Approval: 2005

WARNING: NEUTROPENIA

See full prescribing information for complete boxed warning.

  • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3. (4)
  • It is recommended that frequent peripheral blood cell counts be performed to monitor the occurrence of bone marrow suppression. (4, 5.1, 6.1, 6.2, 6.3)

DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

RECENT MAJOR CHANGES

  • Indications and Usage. (1.3)     09/2013
  • Dosage and Administration. (2.3, 2.5)     09/2013
  • Warnings and Precautions, Hematologic Effects (5.1), Nervous System (5.2), Sepsis (5.3), Pneumonitis (5.4)      09/2013

INDICATIONS AND USAGE

ABRAXANE is a microtubule inhibitor indicated for the treatment of:

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