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mycophenolate mofetil |
| CellCept |
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Pharmaceutical
company:
Roche www.roche.com |
NEW WARNING
Roche issued a “Dear Health Care Professional” letter to alert providers about recently published findings showing an increased incidence of acute organ rejection 12 weeks after transplantation in patients who were switched from therapy with a calcineurin inhibitor to sirolimus (Rapamune) while taking mycophenolate mofetil (CellCept). Mycophenolate mofetil is an immune suppressant used with cyclosporine and corticosteroids to prevent organ rejection in allogeneic kidney, heart, and liver transplants. A clinical trial designed to evaluate improved renal function after withdrawing the calcineurin inhibitor and introducing sirolimus in patients receiving mycophenolate mofetil was stopped prematurely when this unexpected increase in acute organ rejection occurred. Limited data exist to effectively evaluate the cause or incidence of this rejection, but Roche will continue to monitor the safety of mycophenolate mofetil and to urge all providers to report any serious events associated with the use of this drug.
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