Myfortic Use In Pregnancy & Lactation

Women of Child-bearing potential: Myfortic therapy should not be initiated until a negative pregnancy test has been obtained.
Women of childbearing potential must use highly effective contraception before beginning Myfortic therapy, during therapy, and for six weeks after their last dose of Myfortic (see Interactions).
Pregnancy: Use of Myfortic 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 Myfortic, 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 4-5% 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 Myfortic as well. The teratogenic potential of MPA was observed in animal studies (see Toxicology: Non-clinical safety data under Actions).
Myfortic should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus. Patients should be instructed to consult their physician immediately should pregnancy occur.
Breast feeding: It is not known whether MPA is excreted in human milk.
Myfortic should not be used during breast-feeding (see Precautions).
Because many drugs are excreted in human milk, and the potential for serious adverse reactions in breastfed 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.
Fertility: Not applicable.
Male patients: Sexually active men are recommended to use condoms during treatment, and for a total of 13 weeks after their last dose of 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 Myfortic.