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Neoral (Cyclosporine) - Summary

 

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FOR PSORIASIS PATIENTS (SEE ALSO BOXED WARNINGS ABOVE)

Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral®.

Cyclosporine, the active ingredient in Neoral®, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.

 

NEORAL SUMMARY

Neoral

Neoral® is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment.

Neoral® is indicated for the following:

Kidney, Liver, and Heart Transplantation: Neoral® is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral® has been used in combination with azathioprine and corticosteroids.

Rheumatoid Arthritis: Neoral® is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.

Psoriasis: Neoral® is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.

While rebound rarely occurs, most patients will experience relapse with Neoral® as with other therapies upon cessation of treatment.

NEORAL NEWS HIGHLIGHTS

Media Articles Related to Neoral (Cyclosporine)

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

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Published Studies Related to Neoral (Cyclosporine)

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]

Conversion from cyclosporine to tacrolimus in patients at risk for chronic renal allograft failure: 60-month results of the CRAF Study. [2008.05.15]

Cyclosporine 0.05% ophthalmic preparation to aid recovery from loss of corneal sensitivity after LASIK. [2008.04]

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Clinical Trials Related to Neoral (Cyclosporine)

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

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

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

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

Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients [Active, not recruiting]

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Page last updated: 2008-08-10

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