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U.S. Department of Health and Human Services

Safety

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CellCept (mycophenolate mofetil) Capsules, Tablets, Injection and Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

 

  • CellCept (mycophenolate mofetil) 250 mg Capsules
  • CellCept (mycophenolate mofetil) 500 mg Tablets 
  • CellCept(mycophenolate mofetil hydrochloride for injection) 500 mg Intravenous
  • CellCept (mycophenolate mofetil) 200mg/mL Oral Suspension 

 

Summary View

 

WARNINGS

Pure Red Cell Aplasia (PRCA)
  • Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents. The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and
    their combinations in an immunosuppression regimen are also unknown. In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

PRECAUTIONS

Drug Interactions/Ciprofloxacin and Amoxicillin plus Clavulanic Acid
  • A total of 64 CellCept-treated renal transplant recipients received either oral ciprofloxacin 500 mg bid or amoxicillin plus clavulanic acid 375 mg for 7 or at least 14 days. Approximately 50% reductions in median trough MPA concentrations (pre-dose) from baseline (CellCept
    alone) were observed in 3 days following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid. These reductions in trough MPA concentrations tended to diminish within 14 days of antibiotic therapy and ceased within 3 days after discontinuation of antibiotics. The postulated mechanism for this interaction is an antibiotic-induced reduction in glucuronidasepossessing enteric organisms leading to a decrease in enterohepatic recirculation of MPA. The change in trough level may not accurately represent changes in overall MPA exposure; therefore, clinical relevance of these observations is unclear.

ADVERSE REACTIONS

Table
  • hemic is replaced by the word “hematologic”
Postmarketing Experience
  • Hematologic and Lymphatic: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents.

MEDICATION GUIDE

What should I tell my healthcare provider before taking CellCept

  • have Phenylketonuria (PKU). CellCept oral suspension contains aspartame (a source of phenylalanine)
Tell your healthcare provider about all of the medicines you are taking..
  • ganciclovir (Cytovene-IV, Vitrasert),valganciclovir (Valcyte)
  • ciprofloxacin (Cipro, Cipro XR, Ciloxan, Proquin XR) and amoxicillin plus clavulanic acid (Augmentin, Augmentin XR)
How should I take CellCept?
  • brown capsules (replaces orange)
What are the possible side effects of CellCept?
  • red blood cells. You have a higher chance of getting severe anemia when your red blood cell count is low
  • platelets.Also, tell your healthcare provider if you have unusual tiredness, lack of energy, dizziness or fainting