• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Myfortic (mycophenolic acid) delayed-release tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2010

Summary View

 

WARNINGS

Polyomavirus Infections
  • Patients receiving immunosuppressants, including Myfortic are at increased risk for opportunistic infections, including Polyomavirus Infections. Polyomavirus infections in transplant patients may have serious, and sometimes, fatal outcomes.
  • PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss (see ADVERSE REACTIONS). Patient monitoring may help detect patients at risk for PVAN.
  • Cases of PML have been reported in patients treated with MPA derivatives which include mycophenolate mofetil (MMF) and mycophenolate sodium (see ADVERSE REACTIONS). PML, which is sometimes fatal, commonly presents with…
Blood Dyscrasias Including Pure Red Cell Aplasia
  • Patients receiving Myfortic should be monitored for blood dyscrasias (e.g., neutropenia or anemia (see PREACUTIONS, Laboratory Tests). The development of neutropenia may be related to Myfortic itself, concomitant medications, viral infections, or some combination of these events. If blood dyscrasias occur (e.g. neutropenia (ANC <1.3x103 μL or anemia)), dosing with Myfortic should be interrupted or the dose reduced, appropriate diagnostic test performed, and the patient managed appropriately (see DOSAGE AND ADMINISTRATION).
  • Patients receiving Myfortic should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression.

PRECAUTIONS

Drug Interactions
  • Proton Pump inhibitors: In a study conducted in 12 healthy volunteers, the pharmacokinetics of MPA were observed to be similar when a single dose of 720 mg Myfortic was administered alone and following concomitant administration of Myfortic and pantoprazole, which was administered at a dose of 40 mg BID for 4 days.
Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use of Myfortic. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
  • Cases of rash have been reported in patients treated with MPA derivatives