Pregnancy: Use of mycophenolic acid during pregnancy is associated with an increased risk of congenital malformations. Although there are no adequate and well controlled studies in pregnant women conducted with mycophenolic acid, based on data from the US National Transplant Pregnancy Registry (NTPR), use of mycophenolate mofetil in combination with other immunosuppressants during pregnancy was associated with an increased rate of 22% (four cases in 18 liveborn with exposure) of congenital malformations, compared to the rate of 4 to 5% for malformations seen among transplant patients in the NTPR. Congenital malformations that have been reported with mycophenolate mofetil include outer ear and other facial abnormalities including cleft lip and palate, congenital diaphragmatic hernia, anomalies of the distal limbs, heart, esophagus and kidney. Use of mycophenolate mofetil during pregnancy was also reported to be associated with increased risk of spontaneous abortion. Since MMF is converted to MPA following oral or IV administration, the above risks must be taken into account for mycophenolic acid as well. The teratogenic potential of MPA was observed in animal studies (see Pharmacology: Toxicology: Non-Clinical Safety Data under Actions).
Mycophenolic acid should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus. Patients should be instructed to consult their physician immediately should pregnancy occur.
Women of Child-Bearing Potential: Mycophenolic acid therapy should not be initiated until a negative pregnancy test has been obtained.
Women of childbearing potential must use highly effective contraception before beginning therapy, during therapy, and for six weeks after their last dose of mycophenolic acid (see Interactions).
Male Patients: Sexually active men are recommended to use condoms during treatment, and for a total of 13 weeks after their last dose of Mycophenolic acid (Myfortic). In addition, female partners of the male patients are recommended to use highly effective contraception during treatment and for a total of 13 weeks after the last dose of Mycophenolic acid (Myfortic).
Breast-feeding: It is not known whether MPA is excreted in human milk.
Mycophenolic acid (Myfortic) should not be used during breast-feeding (see Precautions).
Because many drugs are excreted in human milk, and of the potential for serious adverse reactions in breast-fed newborns/infants, a decision should be made whether to abstain from breast-feeding while on treatment and during 6 weeks after stopping the therapy or to abstain from using the medicinal product, taking into account the importance of the drug to the mother.