Myfortic Use In Pregnancy & Lactation

Women of child-bearing potential: Myfortic therapy should not be initiated until a negative pregnancy test has been obtained.
Contraception in males and females: Myfortic is contraindicated in women of childbearing potential who are not using highly effective contraception.
Because of the genotoxic and teratogenic potential of Myfortic, women of childbearing potential should use two reliable forms of contraception simultaneously before beginning Myfortic therapy, during Myfortic therapy and for six weeks after their last dose of Myfortic, unless abstinence is the chosen method of contraception.
Sexually active men are recommended to use condoms during treatment, and for at least 90 days after cessation of treatment. Condom use applies for both reproductively competent and vasectomized men, because the risks associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition, female partners of these male patients treated with Myfortic are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of Myfortic.
Pregnancy: Myfortic is contraindicated during pregnancy unless there is no suitable alternative treatment available to prevent transplant rejection.
Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy.
Female and male patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counseled regarding pregnancy prevention and planning.
Before starting Myfortic treatment, women of child bearing potential should have a pregnancy test in order to exclude unintended exposure of the embryo to mycophenolate. Two serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL are recommended; the second test (when appropriate) should be performed 8-10 days after the first one and immediately before starting Myfortic. Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported). Results of all pregnancy tests should be discussed with the patient. Patients should be instructed to consult their physician immediately should pregnancy occur.
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy: Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Congenital malformations, including reports of multiple malformations, have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy. The following malformations were most frequently reported: Abnormalities of the ear (e.g. abnormally formed or absent external/middle ear), external auditory canal atresia; Congenital heart disease such as atrial and ventricular septal defects; Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits; Abnormalities of the eye (e.g. coloboma); Malformations of the fingers (e.g. polydactyly, syndactyly); Tracheo-Oesophageal malformations (e.g. oesophageal atresia); Nervous system malformations such as spina bifida; Renal abnormalities.
In addition there have been isolated reports of the following malformations: Microphthalmia; congenital choroid plexus cyst; septum pellucidum agenesis; olfactory nerve agenesis.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: MPA is excreted in milk in lactating rats. It is unknown whether Myfortic is excreted in human breast milk. Because of the potential for serious adverse reactions to MPA in breast-fed infants, Myfortic is contra-indicated in women who are breast-feeding (see Contraindications).
Fertility: No specific studies with Myfortic in humans have been conducted to evaluate effects on fertility. In a study on male and female fertility in rats no effects were seen up to a dose of 40 mg/kg and 20 mg/kg respectively (see Toxicology: Preclinical safety data under Actions).