CellCept® (mycophenolate mofetil)

• Full Prescribing Information
• Medication Guide
• Medication Guide Announcement

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)

What it Treats

CellCept® (mycophenolate mofetil) is given to people who have received kidney, heart or liver transplants in order to prevent rejection, a process where the immune system perceives the new organ as a "foreign" threat and attacks it.

CellCept, an immunosuppressant medication, is taken along with other antirejection drugs. Please follow your doctor's exact instructions for taking CellCept and all other medications.

Important Safety Information

The use of CellCept during pregnancy is associated with increased risks of first trimester pregnancy loss and birth defects. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning. The use of CellCept along with other medications that help prevent transplanted organs from being rejected may result in an increased chance of getting infections and the possible development of lymphomas and other cancers, especially skin cancer. Patients must contact their doctor right away if they notice any signs of infection (such as fever, tiredness, headache, redness of skin/wound or enlarged glands).

• One pregnancy test must be administered immediately before starting CellCept and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with their doctor.
• Women of childbearing potential must use acceptable birth control during their entire CellCept therapy, and continue birth control for 6 weeks after the patient stops taking CellCept, unless abstinence is the chosen method.
• If a patient becomes pregnant while taking CellCept, she should not stop taking CellCept and should contact her doctor right away. In certain situations, the patient and her doctor may decide that taking CellCept is more important to the patient's health than the possible risks to the patient's unborn baby.
  • The patient and her doctor should report the pregnancy to Mycophenolate Pregnancy Registry (1-800-617-8191)
• CellCept must not be taken by patients with a hypersensitivity (are allergic) to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous must not be taken by patients who are allergic to Polysorbate 80 (TWEEN).
• Patients receiving drugs that suppress the immune system, involving combinations of drugs including CellCept, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other cancers, particularly of the skin.
• Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis (systemic blood infection).
• 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), a serious brain infection, and BK virus-associated nephropathy (BKVAN), a kidney disease.
• Patients should be monitored for low white blood cell count. If this develops, the dose of CellCept will need to be adjusted and the patient monitored by the patient's doctor.
• Cases of pure red cell aplasia (PRCA), a condition in which bone marrow stops making red blood cells, have been reported in patients treated with CellCept in combination with other immunosuppressive agents.
• The most common side effects of CellCept include: diarrhea, leukopenia (a decrease in white blood cells), sepsis (an infection in the blood), vomiting and a higher incidence of certain infections.

For the full prescribing information for CellCept, including Boxed WARNINGS and Medication Guide, please visit www.cellcept.com.