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Mycophenolic acid Pregnancy and Breastfeeding Warnings

Mycophenolic acid is also known as: Myfortic

Mycophenolic acid Pregnancy Warnings

Mycophenolic acid has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of fetal resorptions and malformations in the absence of maternal toxicity. There are no controlled data in human pregnancy. Mycophenolic acid is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. FDA alert May, 2008: The FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF is an ester of mycophenolic acid. The FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure.

Mycophenolate mofetil can cause fetal harm when administered to a pregnant woman. Following oral or IV administration, mycophenolate mofetil is metabolized to mycophenolic acid. Use of mycophenolic acid during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. In the National Transplantation Pregnancy Registry (NTPR), there were data on 33 mycophenolate mofetil-exposed pregnancies in 24 transplant patients; there were 15 spontaneous abortions (45%) and 18 live-born infants. Four of these 18 infants had structural malformations (22%). In postmarketing data (collected from 1995 to 2007) on 77 women exposed to systemic Mycophenolate mofetil during pregnancy, 25 had spontaneous abortions and 14 had a malformed infant or fetus. Six of 14 malformed offspring had ear abnormalities. Because these postmarketing data are reported voluntarily, it is not always possible to reliably estimate the frequency of particular adverse outcomes. These malformations are similar to findings in animal reproductive toxicology studies. For comparison, the background rate for congenital anomalies in the United States is about 3%, and NTPR data show a rate of 4% to 5% among babies born to organ transplant patients using other immunosuppressive drugs. In an animal teratology study performed with mycophenolate sodium, at a dose as low as 1 mg/kg, malformations in the offspring were observed, including anophthalmia, exencephaly, and umbilical hernia. The systemic exposure at this dose represents 0.05 times the clinical exposure at the dose of 1.44 g/day mycophenolic acid. In other animal teratology studies fetal resorptions and malformations occurred from 80 mg/kg/day, in the absence of maternal toxicity (dose levels are equivalent to about 0.8 times the recommended clinical dose, corrected for body surface area). There are no relevant qualitative or quantitative differences in the teratogenic potential of mycophenolate sodium and mycophenolate mofetil. Women using mycophenolic acid at any time during pregnancy should be encouraged to enroll in the National Transplantation Pregnancy Registry. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. Mycophenolic acid therapy should not be initiated until a negative pregnancy test report is obtained. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits. Women of childbearing potential (including pubertal girls and perimenopausal women) taking mycophenolic acid must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting mycophenolic acid therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping mycophenolic acid. If pregnancy does occur during treatment, the physician and patient should discuss the benefit of continuing mycophenolate treatment relative to the risk to the fetus. Patients should be aware that mycophenolic acid reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

Mycophenolic acid Breastfeeding Warnings

There are no data on the excretion of mycophenolic acid into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to mycophenolic acid in nursing infants, a decision should be made to discontinue the drug or discontinue nursing while on treatment or within 6 weeks after stopping therapy, taking into account the importance of the drug to the mother.

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