Label Changes for:

AmBisome (amphotericin B) liposome for Injection

March 2012

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012

 

 

PRECAUTIONS

Drug-Laboratory Interactions: Serum phosphate false elevation
  • False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.

ADVERSE REACTIONS

Postmarketing Experience
  • Rhabdomyolysis
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