Full Prescribing Information (350K/PDF)
Medication Guide (118K/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:

WARNINGS:
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).

Women of childbearing potential must use birth control. Use of CellCept during pregnancy is associated with increased risk of miscarriage and congenital malformations (birth defects).

• 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 medications that help prevent transplanted organs from being rejected have a greater chance of developing lymphomas and other cancers, especially skin cancer.
• Women of childbearing age must use 2 highly effective methods of birth control 4 weeks prior to starting CellCept therapy and continue birth control until 6 weeks after stopping CellCept treatment, unless abstinence is the chosen method. Patients considering pregnancy must talk to their doctor, as CellCept should not be used unless they 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 therapies that suppress the immune system. 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.
• 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.

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