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Label Changes for:

Rapamune (sirolimus) Oral Solution and Tablets

November 2015

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

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

November 2015

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease/Non-Infectious Pneumonitis
  • In some cases, the ILD was reported with pulmonary hypertension (including pulmonary arterial hypertension [PAH]) as a secondary event.

 

April 2010

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

 

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