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U.S. Department of Health and Human Services

Safety

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CellCept (mycophenolate mofetil) February 2007

Audience: Cardiac transplantation healthcare professionals
Indication: Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants

[Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12 weeks post heart transplantation. The safety and efficacy of CellCept in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established.

[February 2007 – Letter – Roche]