Label Changes for:

Rapamune (sirolimus) Oral Solution and Tablets

March 2013

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

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

 

 

March 2013

ADVERSE REACTIONS

Clinical Studies Experience in Prophylaxis of Organ Rejection Following Renal Transplantation
  • ovarian cysts, menstrual disorders (including amenorrhea and menorrhagia)
Postmarketing Experience
  • ovarian cysts, menstrual disorders (including amenorrhea and menorrhagia)

 

 

December 2012

 

MEDICATION GUIDE

Tell your doctor about all medicines you take:
Especially tell your doctor if you take:
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