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U.S. Department of Health and Human Services

Safety

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Rapamune (sirolimus) oral solution and tablet

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

 

 

March 2013

Summary View

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

Summary View

 

MEDICATION GUIDE

Tell your doctor about all medicines you take:
Especially tell your doctor if you take:
  • medicines to treat HIV or hepatitis C

 

November 2010

Summary View

WARNINGS AND PRECAUTIONS

Hyperlidpidemia
  • ...In clinical trials, of patients receiving Rapamune plus cyclosporine or Rapamune after cyclosporine withdrawal, up to 90% of patients required treatment for hyperlipidemia and hypercholesterolemia with anti-lipid therapy (e.g., statins, fibrates). Despite anti-lipid management, up to 50% of patients had fasting serum cholesterol levels > 240 mg/dL and triglycerides above recommended target levels….

ADVERSE REACTIONS

Increased Serum Cholesterol and Triglycerides
  • … Rapamune renal transplant studies, up to 90% of patients required treatment for hyperlipidemia and hypercholesterolemia with anti-lipid therapy (e.g., statins, fibrates). Despite anti-lipid management, up to 50% of patients had fasting serum cholesterol levels > 240 mg/dL and triglycerides above recommended target levels….

MEDICATIONS GUIDE

  • REMS consists of a comprehensive Medication Guide 

 

July 2010

Summary View

WARNINGS and PRECAUTIONS

 

Latent Viral Infections
  • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal have been reported in patients treated with immunosuppressants, including Rapamune. PML commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies and ataxia. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated. Consideration should be given to reducing the amount of immunosuppression in patients who develop PML. In transplant patients, physicians should also consider the risk that reduced immunosuppression represents to the graft.

ADVERSE REACTIONS

 

Postmarketing Experience
  • Infections- Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with immunosuppressants, including Rapamune.