Refrat Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well controlled studies in pregnant women. However, as mycophenolate mofetil has been shown to have teratogenic effects in animals, it may cause fetal harm when administered to a pregnant woman. Therefore, Mycophenolate mofetil should be avoided in pregnant women unless the potential benefit outweighs the potential risk to the foetus.
Women of child bearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy. It is recommended that mycophenolate mofetil therapy should not be initiated by the physician until a report of a negative pregnancy test has been obtained.
Effective contraception must be used before beginning mycophenolate mofetil therapy, during therapy and for six weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occur during treatment the physician and patient should discuss the desirability of continuing the pregnancy.
Breastfeeding: Studies in rats have shown mycophenolate to be excreted in milk. It is not known whether mycophenolate mofetil is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from mycophenolate mofetil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.