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U.S. Department of Health and Human Services

Safety

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Neoral (cyclosporine, modified) soft gelatin capsule and oral solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

 

Summary View

 

WARNINGS

Kidney, Liver, and Heart Transplant
  • Some malignancies may be fatal

PRECAUTIONS

Drug Interactions/Drugs That Alter Cyclosporine Concentrations
  • Cyclosporine is extensively metabolized by CYP 3A isoenzymes, in particular CYP3A4, and is a substrate of the multidrug efflux transporter P-glycoprotein. Various agents are known to either increase or decrease plasma and whole blood cyclosporine concentrations usually by inhibition or induction of CYP3A4 or P-glycoprotein transporter or both.
Drug Interactions/Drugs That Increase Cyclosporine Concentrations
  • nefazodone
Other Drug Interactions
  • Cyclosporine is an inhibitor of CYP3A4 and of the multidrug efflux transporter Pglycoprotein and may increase plasma concentrations of comedications that are substrates of CYP3A4 or P-glycoprotein transporter or both.
  • Cyclosporine may reduce the clearance of...etoposide.
  • Literature and postmarketing cases...including muscle pain.
  • Cyclosporine may increase the plasma concentrations of repaglinide and thereby increase
    the risk of hypoglycemia...

ADVERSE REACTIONS

Kidney, Liver, Heart and Heart Transplantation
  • Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine- containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). Both generalized and localized infections can occur. Pre-existing infections may also be aggravated. Fatal outcomes have been reported.

 

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