Safety

Abraxane Injectable Suspension (paclitaxel protein-bound particles (albumin-bound)) for injectable suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

December 2014

Summary View

WARNINGS AND PRECAUTIONS

Hepatic Impairment
  • … Patients with hepatic impairment may be at increased risk of toxicity,particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression. ABRAXANE is not recommended in patients who have total bilirubin >5 x ULN or AST >10 x ULN. In addition, ABRAXANE is notrecommended in patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST =10 x ULN)…

 

October 2013

Summary View

ADVERSE REACTIONS

Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations
  • Cardiovascular: There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.

 

June 2013

Summary View

ADVERSE REACTIONS

Clinical Trial Experience in Metastatic Breast Cancer
  • sepsis and neutropenic sepsis

 

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