Last update July 14, 2022

Ustekinumab

Compatible

Safe substance and/or breastfeeding is the best option.

Human monoclonal antibody IgG1 that binds to interleukins 12 and 23. It is used to treat severe plaque psoriasis, psoriatic arthritis, and Crohn’s disease and ulcerative colitis. Intravenous and subcutaneous administration every 12 weeks.

Its pharmacokinetic data (very high molecular weight and wide volume of distribution) explain the negligible passage to breast milk observed. (Saito 2022, Bar-Gil 2021, Klenske 2019, Matro 2018)

No clinical problems or a higher rate of infections and no problems with routine vaccinations have been observed in infants of mothers receiving this drug. (Saito 2022, Bar-Gil 2021, Klenske 2019, Mugheddu 2019, Matro 2018)

Due to its protein nature, it is inactivated in the gastrointestinal tract, not being absorbed (practically nil oral bioavailability), which hinders or prevents the passage into plasma of the infant from ingested breast milk (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016 , Mervic 2014, Witzel 2014, Butler 2014), except in premature infants and during the immediate neonatal period, in which there may be greater intestinal absorption. (Sammaritano 2020)

No problems have been detected in infants whose mothers received other similar monoclonal antibodies, such as belimumab, bevacizumab, infliximab, ituximab, tocilizumab, or ustekinumab. (Bar-Gil 2021, LaHue 2020, Saito 2020, 2019 and 2018, Klenske 2019, Mugheddu 2019, Krysko 2019, Matro 2018, Bragnes 2017, Hyrich 2014, Danve 2014)

Various medical societies, expert authors and expert consensus consider the use of this medication during breastfeeding compatible or probably compatible. (Lactmed, Hale, Bar-Gil 2021, Laube 2021, Gisbert 2020, Sammaritano 2020, Lamb 2019, Picardo 2019, Mahadevan 2019, Amin 2018, Götestam 2016, McConnell 2016)

Given the strong evidence that exists on the benefits of breastfeeding for the development of babies and the health of mothers, it is convenient to evaluate the risk-benefit of any maternal treatment, individually advising each mother who wishes to continue breastfeeding. (Koren 2013)

Alternatives

  • Etanercept (Safe substance and/or breastfeeding is the best option.)
  • Infliximab (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

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.
DONATE NOW

Other names

Ustekinumab is also known as


Ustekinumab in other languages or writings:

Groups

Ustekinumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Ustekinumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 0 %
Molecular weight 148.600 daltons
VD 0.06 - 0.16 l/Kg
Tmax 168 - 324 hours
T½ 480 (360 - 768) hours
M/P ratio 0.001 - 0.027 -
Theoretical Dose 0.0005 - 0.24 mg/Kg/d

References

  1. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on April 16, 2024 Full text (link to original source)
  2. 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)
  3. Saito J, Kaneko K, Kawasaki H, Hayakawa T, Yakuwa N, Suzuki T, Sago H, Yamatani A, Murashima A. Ustekinumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk, and infant serum. J Pharm Health Care Sci. 2022 Jul 1;8(1):18. Consulted on July 14, 2022 Abstract Full text (link to original source)
  4. Stratigakis A, Paty D, Zou P, Zhao Z, Li Y, Zhang T. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207 Full text (link to original source) Full text (in our servers)
  5. Bar-Gil Shitrit A, Ben-Horin S, Mishael T, Hoyda A, Yavzori M, Picard O, Grisaru-Granovsky S, Helman S. Detection of Ustekinumab in Breast Milk of Nursing Mothers With Crohn Disease. Inflamm Bowel Dis. 2021 Jan 2. pii: izaa325. Abstract
  6. Laube R, Paramsothy S, Leong RW. Use of medications during pregnancy and breastfeeding for Crohn's disease and ulcerative colitis. Expert Opin Drug Saf. 2021 Jan 7. Abstract
  7. Gisbert JP, Chaparro M. Safety of New Biologics (Vedolizumab and Ustekinumab) and Small Molecules (Tofacitinib) During Pregnancy: A Review. Drugs. 2020 Jul;80(11):1085-1100. Abstract
  8. Saito J, Yakuwa N, Ishizuka T, Goto M, Yamatani A, Murashima A. Belimumab Concentrations in Maternal Serum and Breast Milk During Breastfeeding and the Safety Assessment of the Infant: A Case Study. Breastfeed Med. 2020 Jul;15(7):475-477. Abstract
  9. LaHue SC, Anderson A, Krysko KM, Rutatangwa A, Dorsey MJ, Hale T, Mahadevan U, Rogers EE, Rosenstein MG, Bove R. Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases. Neurol Neuroimmunol Neuroinflamm. 2020 May 27;7(4). pii: e769. Abstract Full text (link to original source)
  10. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract Full text (link to original source)
  11. Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1). pii: e637. Abstract Full text (link to original source) Full text (in our servers)
  12. Whittam DH, Tallantyre EC, Jolles S, Huda S, Moots RJ, Kim HJ, Robertson NP, Cree BAC, Jacob A. Rituximab in neurological disease: principles, evidence and practice. Pract Neurol. 2019 Feb;19(1):5-20. Abstract Full text (link to original source) Full text (in our servers)
  13. Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Abstract Full text (link to original source)
  14. Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H; et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(Suppl 3):s1-s106. Abstract Full text (link to original source)
  15. Picardo S, Seow CH. A Pharmacological Approach to Managing Inflammatory Bowel Disease During Conception, Pregnancy and Breastfeeding: Biologic and Oral Small Molecule Therapy. Drugs. 2019 Jul;79(10):1053-1063. Abstract
  16. Klenske E, Osaba L, Nagore D, Rath T, Neurath MF, Atreya R. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn's Disease. J Crohns Colitis. 2019 Feb 1;13(2):267-269. Abstract
  17. Mugheddu C, Atzori L, Lappi A, Murgia S, Rongioletti F. Biologics exposure during pregnancy and breastfeeding in a psoriasis patient. Dermatol Ther. 2019 May;32(3):e12895. Abstract
  18. Saito J, Yakuwa N, Kaneko K, Takai C, Goto M, Nakajima K, Yamatani A, Murashima A. Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum. Rheumatology (Oxford). 2019 Aug 1;58(8):1505-1507. Abstract
  19. Saito J, Yakuwa N, Takai C, Nakajima K, Kaneko K, Goto M, Ishikawa Y, Murashima A. Tocilizumab concentrations in maternal serum and breast milk during breastfeeding and a safety assessment in infants: a case study. Rheumatology (Oxford). 2018 Aug 1;57(8):1499-1501. Abstract
  20. Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. Abstract Full text (link to original source) Full text (in our servers)
  21. Rademaker M, Agnew K, Andrews M, Armour K, Baker C, Foley P, Frew J, Gebauer K, Gupta M, Kennedy D, Marshman G, Sullivan J. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018 May;59(2):86-100. Abstract
  22. Amin M, No DJ, Egeberg A, Wu JJ. Choosing First-Line Biologic Treatment for Moderate-to-Severe Psoriasis: What Does the Evidence Say? Am J Clin Dermatol. 2018 Feb;19(1):1-13. Abstract
  23. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  24. Bragnes Y, Boshuizen R, de Vries A, Lexberg Å, Østensen M. Low level of Rituximab in human breast milk in a patient treated during lactation. Rheumatology (Oxford). 2017 Jun 1;56(6):1047-1048. Abstract
  25. 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)
  26. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016;2016:6527458. Abstract Full text (link to original source) Full text (in our servers)
  27. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  28. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  29. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014;23(2):27-31. Abstract Full text (link to original source) Full text (in our servers)
  30. Witzel SJ. Lactation and the use of biologic immunosuppressive medications. Breastfeed Med. 2014 Dec;9(10):543-6. Abstract Full text (link to original source) Full text (in our servers)
  31. Danve A, Perry L, Deodhar A. Use of belimumab throughout pregnancy to treat active systemic lupus erythematosus: a case report. Semin Arthritis Rheum. 2014 Oct;44(2):195-7. Abstract
  32. Hyrich KL, Verstappen SM. Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford). 2014 Aug;53(8):1377-85. Abstract Full text (in our servers)
  33. 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
  34. Ross E, Robinson SE, Amato C, McMillan C, Westcott J, Wolf T, Robinson WA. Therapeutic monoclonal antibodies in human breast milk: a case study. Melanoma Res. 2014 Apr;24(2):177-80. Abstract
  35. Koren G, Carey N, Gagnon R, Maxwell C, Nulman I, Senikas V; Society of Obstetricians and Gynaecologists of Canada. Cancer chemotherapy and pregnancy. J Obstet Gynaecol Can. 2013 Mar;35(3):263-278. Abstract Full text (link to original source) Full text (in our servers)
  36. Ustekinumab. Ficha técnica. 2013 Full text (in our servers)
  37. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  38. Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012 Sep;46(8):718-9. Abstract
  39. Weber J, Keam SJ. Ustekinumab. BioDrugs. 2009 Abstract

Total visits

9,523

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2015 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM