CellCept and Pregnancy
If CellCept (mycophenolate mofetil) is used during the first trimester of pregnancy, it could cause miscarriage or various birth defects. Due to these and other serious risks, the medication has a pregnancy Category D rating. This means that it should not be used in pregnancy unless the benefits outweigh the risks.
Can Pregnant Women Take CellCept?CellCept® (mycophenolate mofetil) is a prescription medication approved to prevent organ rejection in people who have received renal (kidney), cardiac (heart), or hepatic (liver) transplants. CellCept is a pregnancy Category D medicine because it may cause fetal harm if taken during pregnancy.
What Is Pregnancy Category D?The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
When used in the first trimester of pregnancy, CellCept may cause miscarriage and various birth defects. Some of the birth defects associated with CellCept use include external ear and facial malformations (including cleft lip and palate), as well as abnormal development of the hands, legs, heart, esophagus, and kidneys.
CellCept is generally not recommended for use in pregnant women. However, if other anti-rejection medicines are not an option, CellCept may be used during pregnancy because the risk of not treating a woman after an organ transplant would be greater than the risk of using the medication.
Women of childbearing potential should have a negative pregnancy test prior to beginning treatment with CellCept, 8 to 10 days later (after the first test), and at every routine doctor visit after that.
If you are a woman of childbearing potential, you will receive contraceptive counseling and be advised to use two forms of birth control (your healthcare provider will advise you about acceptable methods and combinations of methods of birth control). Women who have had tubal ligation, have an intrauterine device (IUD), or whose partners have had a vasectomy do not usually need an additional method of birth control. Women who can commit to abstinence (completely avoiding heterosexual intercourse) may not need birth control.
It is recommended that you use birth control the entire time during treatment with CellCept and for at least six weeks after stopping the medicine.
You should also know that CellCept might reduce the effectiveness of oral contraceptives (see CellCept Drug Interactions).