FDA Approves Drug for Prevention of Organ Rejection in Pediatric Recipients of Heart and Liver Transplants - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populations

FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogeneic liver transplants aged 3 months and older in combination with other immunosuppressants. CellCept has been approved for the following indications:  

  • Adult kidney transplant on May 3, 1995 
  • Adult heart transplant on February 11, 1998 
  • Adult liver transplant on July 28, 2000 
  • Pediatric kidney transplant on December 20, 2000 

CellCept has a boxed warning for increased risks of first trimester pregnancy loss and congenital malformations. Prescribing information also notes an increased risk of development of lymphoma and other malignancies and an increased susceptibility to bacterial, viral, fungal, and protozoal infections. 

In addition, the most common adverse reactions in clinical trials include diarrhea, leukopenia, infection, and vomiting, and there is evidence of a higher frequency of opportunistic infections. 

The use of CellCept in pediatric heart transplant and liver transplant patients is based on pediatric extrapolation of efficacy from adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. Additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients. 

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