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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Mycophenolate

Last Revision: September 20, 2021.

Estimated reading time: 2 minutes

CASRN: 24280-93-1

image 388369430 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Information from one patient indicates that relatively large amounts of mycophenolate are excreted into breastmilk, with peak milk levels at about 2 hours after a dose of the delayed-release formulation (Myfortic). A few infants have reportedly been breastfed during mycophenolate therapy, with no adverse effects reported. Because little information is available on the use of mycophenolate during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. A woman was treated for lupus nephritis with delayed-release mycophenolate (Myfortic) in a dose of 720 mg in the morning and evening and 360 mg midday for a total of 21.6 mg/kg daily. Steady-state milk samples before and at 2 and 4 hours after a morning dose of 720 mg contained 35 mg/L, 80 mg/L, and 28 mg/L, respectively.[1,2] An exact relative infant dosage cannot be calculated from these data points, but the value lies between 19% and 56% (probably closer to 19%) of the mother’s weight-adjusted dosage using the standard milk intake of 150 mL/kg daily.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

The National Transplantation Pregnancy Registry (renamed Transplant Pregnancy Registry International) collected information on 6 mothers (5 kidney and 2 heart transplants) who breastfed 7 infants while taking a mycophenolate product. The maximum time that any of the infants was breastfed was 14 months. None of the infants had any reported adverse reactions.[3] Another case series from the Transplant Pregnancy Registry International reported women who received heart transplants reported that 3 women breastfed their infants while taking mycophenolate. Durations of breastfeeding and infant outcomes were not reported.[4] It is possible that some of these women were the same as those in the case series above.

In case series of 77 patients from the UK who received either a liver or cardiothoracic transplant, 9 took mycophenolate mofetil throughout pregnancy. Overall, 60% breastfed their infants, although the exact number who breastfed with mycophenolate or their outcomes were not reported.[5]

An Australian case series reported 3 women with heart transplants who had a total of 5 infants, all of whom were breastfed (extent not stated). Two of the women took mycophenolate mofetil postpartum, one in a dosage of 720 mg twice daily and the other woman in a dosage of 1 gram twice daily. No adverse infant effects were reported up to the times of hospital discharge.[6]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Azathioprine, Cyclosporine, Tacrolimus

References

1.
Huerta A, Caballero Bermejo AF, de Villa LF, et al. Measurement of the passage of mycophenolic acid into breast milk in a patient with lupus nephritis. Kidney Int. 2021;100:711. [PubMed: 34420668]
2.
Ruiz‐Antorán B. Personal communication. August 26 & 30, 2021.
3.
Constantinescu S, Pai A, Coscia LA, et al. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014;28:1163–73. [PubMed: 25271063]
4.
Punnoose LR, Coscia LA, Armenti DP, et al. Pregnancy outcomes in heart transplant recipients. J Heart Lung Transplant. 2020;39:473–80. [PubMed: 32201090]
5.
Mohamed-Ahmed O, Nelson-Piercy C, Bramham K, et al. Pregnancy outcomes in liver and cardiothoracic transplant recipients: A UK national cohort study. PLoS One. 2014;9:e89151. [PMC free article: PMC3929648] [PubMed: 24586554]
6.
Boyle S, Sung-Him Mew T, Lust K, et al. Pregnancy following heart transplantation: A single centre case series and review of the literature. Heart Lung Circ. 2021;30:144–53. [PubMed: 33162367]

Substance Identification

Substance Name

Mycophenolate

CAS Registry Number

128794-94-5; 24280-93-1

Drug Class

Breast Feeding

Lactation

Immunosuppressive Agents

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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