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U.S. Department of Health and Human Services

Safety

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Rapamune (sirolimus)oral solution and tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010

 

Summary View

 

WARNINGS AND PRECAUTIONS

Fluid Accumulation and Wound Healing
  • ascites
Assay for Sirolimus Therapeutic Drug Monitoring
  • Currently in clinical practice, sirolimus whole blood concentrations are being measured by various chromatographic and immunoassay methodologies. Patient sample concentration values from different assays may not be interchangeable

ADVERSE REACTIONS

  • Cardiovascular: and fluid accumulation
  • Digestive System: Ascites