Myfortic Use In Pregnancy & Lactation

Use of mycophenolic acid during pregnancy is associated with an increased risk of pregnancy loss including spontaneous abortion and/or congenital malformations. Mycophenolic acid (Myfortic) therapy should not be initiated in females of reproductive potential until a negative pregnancy test has been obtained. For information on use in pregnancy and contraceptive requirements (see PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL as follows). Mycophenolic acid should not be used during breast-feeding (see PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL as follows).
Pregnancy: Risk summary: Use of mycophenolic acid during pregnancy is associated with an increased risk of spontaneous abortion and 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 previously mentioned risks must be taken into account for mycophenolic acid as well. The teratogenic potential of MPA was observed in animal studies (see ANIMAL DATA as follows).
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.
Animal data: In a teratology study in rats, administration of mycophenolic acid (Myfortic) during organogenesis resulted in malformations including anophthalmia, exencephaly and umbilical hernia, at an oral dose as low as 1 mg/kg/day. The systemic exposure at this dose represents 0.05 times the clinical exposure at the MRHD (maximum recommended human dose) of 1440 mg/day mycophenolic acid (Myfortic). In a pre- and postnatal development study in rats oral administration of mycophenolic acid (as sodium salt) during gestation and lactation caused developmental delays (abnormal pupillary reflex in females and preputial separation in males) at the highest dose of 3 mg/kg, which is below MRHD based on body surface area.
Lactation: Risk summary: It is not known whether MPA is transferred into human milk. There are no data on the effects of mycophenolic acid (Myfortic) on the breastfed child or on milk production.
As many drugs are transferred into human milk, and due to the potential for serious adverse reactions in breast-fed newborns/infants, a decision should be made whether to abstain from breast-feeding during treatment and for 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 (see PRECAUTIONS).
Females and males of reproductive potential: Pregnancy testing: Mycophenolic acid (Myfortic) therapy should not be initiated until a negative pregnancy test has been obtained.
Contraception:Females: Females of reproductive potential must use effective contraception (methods that result in less than 1 % pregnancy rates) before beginning mycophenolic acid (Myfortic) therapy, during therapy and for six weeks after their last mycophenolic acid (Myfortic) dose (see INTERACTIONS).
Males: Male patients are recommended to use condoms during treatment, and for a total of 13 weeks after their last mycophenolic acid (Myfortic) dose. Accordingly, male patients of reproductive potential should be made aware of and discuss with a qualified health-care professional the potential risks of fathering a child or donating semen. In addition, female partners of the male patients are recommended to use effective contraception (methods that result in less than 1 % pregnancy rates) during treatment and for a total of 13 weeks after the last mycophenolic acid (Myfortic) dose.
Infertility: There is no data on the effect of mycophenolic acid (Myfortic) on human fertility. Mycophenolate sodium had no effect on male and female rat's fertility at oral doses up to 40 mg/kg/day and 20 mg/kg/day respectively, equivalent to 9 and 4.5 (calculated) times the clinical exposure at the MRHD of 1440 mg mycophenolic acid (Myfortic) per day (see PHARMACOLOGY: TOXICOLOGY: NON-CLINICAL SAFETY DATA under ACTIONS).