Last update June 6, 2020

Mycophenolate Mofetil

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Immunosuppressant indicated in the prophylaxis of acute renal, cardiac or liver allogeneic transplant rejection.
Oral administration twice a day.

Since the last update we have not found any published data on its excretion in breast milk.

Its pharmacokinetic data (large volume of distribution and high percentage of protein binding) makes transfer into breastmilk in significant quantities unlikely.
No problems have been observed in infants breastfed for up to 14 months whose mothers were taking it (Constantinescu 2014).
Its use is authorized in infants from 3 months of age (FDA 2018).

Mycophenolate is considered unsafe during lactation by various medical societies and expert consensus (Hale 2019, Birru 2020, Brown 2017, Briggs 2017, (Shah 2016), Flint 2016, Götestam 2016, Noviani 2016, Butler 2014, Weber 2008, Mahadevan 2006, Østensen 2006, Temprano 2005).
Until there is more published data on this drug in relation to breastfeeding, safer known alternatives are preferable (Shah 2016), especially during the neonatal period and in cases of prematurity.

Alternatives

  • Azathioprine (Safe substance and/or breastfeeding is the best option.)
  • Ciclosporin (Safe substance and/or breastfeeding is the best option.)
  • Prednisone (Safe substance and/or breastfeeding is the best option.)
  • Tacrolimus (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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Other names

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Mycophenolate Mofetil in other languages or writings:

Group

Mycophenolate Mofetil belongs to this group or family:

Tradenames

Main tradenames from several countries containing Mycophenolate Mofetil in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 94 %
Molecular weight 434 daltons
Protein Binding 97 %
VD 3.6 ± 1.5 l/Kg
pKa 9.76 -
Tmax 1 - 1.5 hours
T½ 17. 9 ± 6.5 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. Birru Talabi M, Clowse MEB. Antirheumatic medications in pregnancy and breastfeeding. Curr Opin Rheumatol. 2020 May;32(3):238-246. Abstract
  3. FDA. Mycophenolate. Drug summary. 2018 Full text (in our servers)
  4. Brown SM, Aljefri KA, Waas R, Hampton PJ. Systemic medications used in treatment of common dermatological conditions: Safety profile with respect to pregnancy, breast feeding and content in seminal fluid. J Dermatolog Treat. 2017 Abstract
  5. Shah S, Verma P. Overview of Pregnancy in Renal Transplant Patients. Int J Nephrol. 2016;2016:4539342. Abstract
  6. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  7. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  8. Noviani M, Wasserman S, Clowse ME. Breastfeeding in mothers with systemic lupus erythematosus. Lupus. 2016 Aug;25(9):973-9. Abstract
  9. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  10. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  11. Constantinescu S, Pai A, Coscia LA, Davison JM, Moritz MJ, Armenti VT. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014 Nov;28(8):1163-73. Abstract
  12. Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Dec;29(12):1017-23. Abstract
  13. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  14. Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
  15. AEMPS. Micofenolato. Ficha técnica. 2006 Full text (in our servers)
  16. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract

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