CellCept Use In Pregnancy & Lactation

Pregnancy: CellCept is contraindicated during pregnancy due to its mutagenic and teratogenic potential (see Contraindications). CellCept is a human teratogen, with an increased risk of spontaneous abortions (mainly in the first trimester) and congenital malformations in case of maternal exposure during pregnancy (see Post Marketing under Adverse Reactions). In the medical literature, the risk of spontaneous abortions has been reported as 45 to 49% following mycophenolate mofetil exposure, compared to a reported rate between 12 and 33% in solid organ transplant patients treated with other immunosuppressants.
Congenital malformations (including multiple malformations in individual newborns) have been reported in 23 to 27% of live births in mycophenolate mofetil exposed pregnancies in published literature. For comparison the risk of malformations is estimated at approximately 2% of live births in the overall population and at approximately 4 to 5 % in solid organ transplant patients treated with immunosupressants other than mycophenolate mofetil.
The following malformations were most frequently reported post-marketing, in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy: Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits; Abnormalities of the ear (e.g. abnormally formed or absent external/middle ear) and eye (e.g. coloboma, microphthalmos); Malformations of the fingers (e.g. polydactyly, syndactyly, brachydactyly); Cardiac abnormalities such as atrial and ventricular septal defects; Esophageal malformations (e.g. esophageal atresia); Nervous system malformations (such as spina bifida).
These findings were consistent with teratology studies performed in rats and rabbits where fetal resorptions and malformations occurred in absence of maternal toxicity (see Pharmacology: Toxicology: Reproductive Toxicity under Actions).
Labor and delivery: The safe use of CellCept during labor and delivery has not been established.
Lactation: It is not known whether the CellCept is excreted in human breast milk. Due to the potential for serious adverse reactions in nursing infants, CellCept is contraindicated during breastfeeding (see Contraindications).
Although the relevance to humans is unknown, studies in rats have shown mycophenolate mofetil to be excreted in milk.