Label Changes for:
CellCept (mycophenolate mofetil) capsules, tablets, intravenous injection and oral suspension
Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.
- CellCept (mycophenolate mofetil) 250 mg capsules
- CellCept (mycophenolate mofetil) 500 mg tablets
- CellCept (mycophenolate mofetil hydrochloride) 500 mg/ 20 mL for intravenous injection
- CellCept (mycophenolate mofetil) 200 mg/ mL oral suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009
Progressive Multifocal leukoencephalopathy
- Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN) which have been observed in patients receiving immunosuppressants, including Cellcept.
- BKVAN is associated with serious outcomes, including deteriorating renal function and renal graft loss. Patient monitoring may help detect patients at risk for BK virus associated nephropathy. Reduction in immunosuppression should be considered for patients who develop evidence of BK virusassociated nephropathy.
Postmarketing Experience/Resistance Mechanism Disorder
- ...BK virus-associated nephropathy has been observed in patients receiving immunosuppressants, including CellCept. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
“What is the most important information I should know about CellCept?”
- Viral infections: Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with CellCept include:
- shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections
- BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.