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Sandimmune (Cyclosporine) - Summary

 


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Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED.

      Sandimmune® and Neoral® are not bioequivalent and cannot be used interchangeably without physician supervision.

      The absorption of cyclosporine during chronic administration of Sandimmune® Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed. (See Blood Level Monitoring under DOSAGE AND ADMINISTRATION.)

 

SANDIMMUNE SUMMARY

Sandimmune

Cyclosporine, the active principle in Sandimmune® (cyclosporine) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea.

Sandimmune® (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Because of the risk of anaphylaxis, Sandimmune® Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.


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SANDIMMUNE NEWS HIGHLIGHTS

Media Articles Related to Sandimmune (Cyclosporine)

Drug and Device Approvals: Europe and Japan
Source: Medscape Primary Care Headlines [2004.08.24]

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Published Studies Related to Sandimmune (Cyclosporine)

Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome. [2008.11]

Dosing and safety of cyclosporine in patients with severe brain injury. [2008.10]

Effect of cyclosporine on reperfusion injury in acute myocardial infarction. [2008.07.31]

Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome. [2008.07.12]

CMV infections after two doses of daclizumab versus thymoglobulin in renal transplant patients receiving mycophenolate mofetil, steroids and delayed cyclosporine A. [2008.06]

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Clinical Trials Related to Sandimmune (Cyclosporine)

Metabolic Pattern of Cyclosporine A and Acute Renal Failure [Completed]

Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery? [Completed]

Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation [Completed]

Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels [Active, not recruiting]

The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients [Active, not recruiting]

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Page last updated: 2008-11-03

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