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U.S. Department of Health and Human Services

Safety

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Aloxi (palonosetron hydrochloride) Injection

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

 

May 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use
  • ...Chemotherapy-Induced Nausea and Vomiting studies added.

 

February 2014

Summary View

WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists.