CellCept® (mycophenolate mofetil)

• Full Prescribing Information
• Healthcare Provider Letters

  7 letters

  Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) - 2012 Reports of Pure Red Cell Aplasia - Aug 2009 Pregnancy Notice - 2010 Pharmacists: Important New Dispensing Information - Jan 2009 Introduction of a CellCept Medication Guide - Jan 2009 Important Changes in the CellCept® Prescribing Information - Oct 2007 Important Changes in the CellCept® Prescribing Information - June 2008
• Material Safety Data Sheets

Alert

Drug Recall Notice (PDF) - June 27, 2011
Voluntary drug recall of select lots of CellCept® Oral Suspension (mycophenolate mofetil for oral suspension) 200mg/mL 225mL Bottle (NDC # 0004-0261-29)

Indication

CellCept® (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection inpatients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.

CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days;patients should be switched to oral CellCept as soon as they can tolerate oral medication.

Important Safety Information and BOXED WARNINGS

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should prescribe CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

•  Pregnancy category D: Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant female. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
• CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
• Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
• Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis.
• Immunosuppressed patients are at increased risk of opportunistic infections, including activation of latent viral infections. These include sometimes fatal cases of progressive multifocal leukoencephalopathy (PML) and BK virus-associated nephropathy (BKVAN). In immunosuppressed patients with neurological symptoms, consider PML in the differential diagnosis and consult with a neurologist as clinically indicated. Consider reducing the amount of immunosuppression and be cognizant of the risk that reduced immunosuppression represents to the graft. Consider reducing immunosuppression for patients who develop evidence of BKVAN.
• Monitor patients for neutropenia. If neutropenia develops [absolute neutrophil count (ANC) <1.3 x 103/μL], interrupt or reduce dosing with CellCept, perform appropriate diagnostic tests and manage patient appropriately.
• Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents.
• CAUTION: NEVER ADMINISTER CELLCEPT INTRAVENOUS SOLUTION BY RAPID OR BOLUS INTRAVENOUS INJECTION.
• Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
  •  Pregnancy Testing: a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL must be administered immediately before starting CellCept. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations, please report the pregnancy to Mycophenolate Pregnancy Registry (1-800-617-8191).
  • Contraception: Patients taking CellCept must receive contraceptive counseling and use acceptable contraception (see Table 8 of the full Prescribing Information for acceptable contraception methods). Patients must use acceptable birth control during entire CellCept therapy, and for 6 weeks after stopping CellCept, unless the patient chooses abstinence.
• The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections, e.g., opportunistic infections. Phlebitis and thrombosis have been reported with intravenous administration. Please refer to the full Prescribing Information for additional ADVERSE REACTIONS.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, at www.cellecpt.com for additional important safety information.