The Food and Drug Administration (FDA) has expanded the approval of CellCept (mycophenolate mofetil) to include prophylaxis of organ rejection in pediatric recipients of allogeneic heart and liver transplants.
CellCept is now indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
The approval was 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 included pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients.
The most common adverse reactions with CellCept include diarrhea, leukopenia, infection, and vomiting. There is also evidence of a higher frequency of certain types of infections.
- FDA approves expansion of CellCept (mycophenolate mofetil) indication to pediatric heart transplant and pediatric liver transplant populations. News release. US Food and Drug Administration. Accessed June 8, 2022. https://content.govdelivery.com/accounts/USFDA/bulletins/31b25c1
- CellCept. Package insert. Genentech; 2022. Accessed June 8, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf