Mycophenolate mofetil Pregnancy and Breast Feeding Warnings

Mycophenolate mofetil is also known as: CellCept

Overview

Mycophenolate Mofetil Solution may cause birth defects or fetal death if you take it while you are pregnant. Do not become pregnant while you are using Mycophenolate Mofetil Solution. If you think you may be pregnant, contact your doctor right away. It is not known if Mycophenolate Mofetil Solution is found in breast milk. Do not breast-feed while using Mycophenolate Mofetil Solution.

Mycophenolate mofetil Pregnancy Warnings

Mycophenolate mofetil has been assigned to pregnancy category D by the FDA. Mycophenolate mofetil has been associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. There are no controlled data in human pregnancy. Mycophenolate mofetil 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. 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 pregnancy test within 1 week of beginning mycophenolate mofetil. Women of childbearing potential (including pubertal girls and perimenopausal woman) taking mycophenolate mofetil should receive contraceptive counseling and use effective contraception. Effective contraception should be used before, during and for 6 weeks following discontinuation of therapy. The manufacturer recommends that 2 reliable forms of contraception be used simultaneously. If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing the pregnancy. Healthcare professionals and patients should be aware that mycophenolate mofetil reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

Mycophenolate mofetil Lactation Warnings

There are no data on the excretion of mycophenolic acid (the active metabolite of mycophenolate mofetil) into human milk. The manufacturer suggests a decision should be made whether to continue nursing or to discontinue the drug, considering the importance of the drug to the mother and the potential for serious adverse events if the infant were exposed.

Mycophenolate mofetil is excreted into the milk of lactating rats.

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