Full Prescribing Information (243K/PDF)
Medication Guide (97K/PDF)
Change in CellCept Label for Pregnancy Outcomes - Dear Health Care Professional Letter - October 2007 (53K/PDF)
Change in CellCept label for Progressive Multifocal Leukoencephalopathy (PML) - Dear Health Care Professional Letter - June 2008 (68K/PDF)
Change in CellCept label for Introduction of Medication Guide - Dear Healthcare Provider Letter - January 2009 (42K/PDF)
Change in CellCept label for Introduction of Medication Guide - Dear Pharmacist Letter - January 2009 (41K/PDF)
Change in CellCept label for Pure Red Cell Aplasia (PRCA) - Dear Healthcare Provider Letter - August 2009 (52K/PDF)

02-13-2009 CellCept® (mycophenolate mofetil) Important New Dispensing Information Issuance of a Medication Guide (538K/PDF)

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 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. People taking CellCept in combination with other antirejection medications have a greater chance of developing lymphomas and other cancers, especially skin cancer.
• If you are a woman of childbearing age, you must use 2 highly effective methods of contraception 4 weeks prior to starting CellCept therapy and continue contraception until 6 weeks after stopping CellCept treatment, unless abstinence is the chosen method. If you are considering pregnancy, be sure to talk to your doctor, as CellCept should not be used unless you cannot be successfully treated with other immunosuppressant drugs.
• Cases of progressive multifocal leukoencephalopathy (PML), an infection of the brain that is sometimes fatal, have been reported in patients treated with CellCept. In reported cases, patients generally had risk factors for PML, including treatment with immunosuppressant therapies. The most common symptoms may include: clumsiness, progressive weakness, loss of movement or function in one side of the body, and changes in vision, speech or personality.
• Severe neutropenia (a decrease in neutrophils, a type of white blood cell) has been reported in up to 2% of kidney, 2.8% of heart and 3.6% of liver transplant patients receiving CellCept at a dose of 3 grams daily.
• Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents. PRCA is a type of anemia in which there is a decrease of red blood cells. Symptoms may include unusual tiredness, lack of energy, dizziness or fainting.
• Gastrointestinal bleeding (requiring hospitalization) has been reported in approximately 3% of kidney, 1.7% of heart and 5.4% of liver transplant patients treated with CellCept at a dose of 3 grams daily.

Please be sure to talk to your doctor if you have any questions about your condition or treatment.

View full prescribing information for additional safety information.