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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) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Proteinuria

ADVERSE REACTIONS

  • Conversion from Calcineurin Inhibitors to Rapamune in Maintenance Renal
    Transplant Population

WARNINGS AND PRECAUTIONS

Proteinuria

...Patients with the greatest amount of urinary protein excretion prior to Rapamune conversion were those whose protein excretion increased the most after conversion. New onset nephrosis (nephrotic syndrome) was also reported as a treatment emergent adverse event in 2.2% of the Rapamune conversion group patients in comparison to 0.4% in the CNI continuation group of patients...