Mycophenolate mofetil Pregnancy and Breastfeeding Warnings

Brand names: CellCept, Myhibbin

Medically reviewed by Drugs.com. Last updated on Nov 13, 2022.

Mycophenolate mofetil Pregnancy Warnings

Use should be avoided.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Use of this drug during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems. It is recommended to consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.

Comments:
-This drug can harm a fetus.
-Females and males of reproductive potential should be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and should be counseled regarding pregnancy prevention and planning.
-Prior to starting therapy with this drug, female patients of childbearing potential should have 2 negative serum or urine pregnancy tests with a sensitivity of at least 25 milli-international units per milliliter (mIU/mL). The second test should be performed 8 to 10 days after the first one and immediately before starting therapy. Repeat pregnancy tests should be performed during routine follow-up visits.
-Women of child bearing potential should use acceptable reliable forms of contraception, including at least one highly effective method, before beginning therapy, during therapy, and for 6 weeks following discontinuation of therapy, unless abstinence is the chosen method of contraception.
-Sexually active men should 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.
-Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation.
-Female partners of male patients should use highly effective contraception during treatment and for a total of 90 days after the last dose.

Use of this drug 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, kidney, and nervous system. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation. Healthcare professionals and patients should be aware that this drug reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Mycophenolate mofetil Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data on the presence of this drug in human milk, or the effects on milk production.
-The National Transplantation Pregnancy Registry has limited data on the effects of this drug on a breastfed child.

Because no information is available on the use of this drug during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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