It is recommended that mycophenolate mofetil therapy should not be initiated until a negative pregnancy test has been obtained. Effective contraception must be used before beginning mycophenolate mofetil therapy, during therapy, and for six weeks following discontinuation of therapy (see Interactions). Patients should be instructed to consult their physician immediately should pregnancy occur.
The use of mycophenolate mofetil is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available. mycophenolate mofetil should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus. There is limited data from the use of mycophenolate mofetil in pregnant women. However, congenital malformations including ear malformations, i.e. abnormally formed or absent external/middle ear, have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy. Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known whether this substance is excreted in human milk. Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, mycophenolate mofetil is contraindicated in nursing mothers (see Contraindications).