Last update Feb. 25, 2021

Βεδολιζουμάμπη

Compatible

Safe substance and/or breastfeeding is the best option.

Humanized recombinant IgG1 monoclonal antibody that blocks the α4β7 integrin of T lymphocytes that migrate to the intestine.
It acts as a biological immunosuppressant specific to the intestine.
Indicated in the treatment of ulcerative colitis and Crohn's disease when unresponsive to other treatments.
Its possible side effects are relatively benign: upper respiratory tract infections with or without fever, fatigue and headaches or joint pain.
Administration by intravenous infusion at weeks 0, 2, 6 and then every 8 weeks (AEMPS-EMA-Takeda 2018).

Its very high molecular weight explains the small transfer to milk observed (Sun 2021, Lahat 2018, Julsgaard 2018).
No problems have been observed in infants of mothers treated with this drug (Sun 2021, Moens 2020 and 2019, Lahat 2018, Julsgaard 2018).

Due to its protein nature, it is inactivated in the gastrointestinal tract without being absorbed (practically nil oral bioavailability) and this hinders or prevents its passage into the infant´s plasma from ingested breast milk (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016 , Witzel 2014, Butler 2014, Mervic 2014) except for premature infants and during the immediate neonatal period when there might be a greater intestinal permeability (Sammaritano 2020).

No problems have been detected in infants whose mothers received other similar monoclonal antibodies such as belimumab, bevacizumab, infliximab, rituximab, 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).

Several medical associations, experts and expert consensus consider the use of this medication to be probably compatible with breastfeeding (Hale 2019 p776, Matro 2018, Briggs 2017, Mahadevan 2017, McConnell 2016, Mahadevan 2015).
Expert authors consider that the use of monoclonal antibodies during breastfeeding is safe or very likely to be safe (Whittam 2019, Matro 2018, Anderson 2018 and 2016, Witzel 2014, Pistilli 2013).

Given the strong evidence that exists on the benefits of breastfeeding and the development of babies and the health of their mothers, it might be appropriate to evaluate the risk-benefit of any maternal treatment, including chemotherapy, and counsel individually each mother who wishes to continue breastfeeding (Koren 2013).


See below the information of this related product:

Alternatives

We do not have alternatives for Βεδολιζουμάμπη since it is relatively safe.

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.

Groups

Βεδολιζουμάμπη belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Βεδολιζουμάμπη in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 146.837 daltons
VD 0.07 l/Kg
Tmax 96 (48 - 192 hours
336 - 362 hours
M/P ratio 0.004 - 0.02 -
Theoretical Dose 0.02 (0.01 - 0.03) mg/Kg/d
Relative Dose 24 (11 - 30) %

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. 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)
  4. 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
  5. Sun W, Fennimore B, Beaulieu DB, Arsenescu R, Stein AC, Chen J, Lin T, McKnight S, Kadali H, Rosario M, Lirio RA. Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease. Clin Pharmacokinet. 2021 Feb 5. Abstract Full text (link to original source) Full text (in our servers)
  6. 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)
  7. 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)
  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. 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)
  10. 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
  11. 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
  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. 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
  14. 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
  15. 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)
  16. AEMPS - Takeda. Vedolizumab (Entyvio). Ficha técnica. 2018 Full text (in our servers)
  17. EMA - Takeda. Vedolizumab (Entyvio). Drug Summary. 2018 Full text (in our servers)
  18. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  19. 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
  20. 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
  21. Lahat A, Shitrit AB, Naftali T, Milgrom Y, Elyakim R, Goldin E, Levhar N, Selinger L, Zuker T, Fudim E, Picard O, Yavzori M, Ben-Horin S. Vedolizumab Levels in Breast Milk of Nursing Mothers With Inflammatory Bowel Disease. J Crohns Colitis. 2018 Jan 5;12(1):120-123. Abstract
  22. Julsgaard M, Kjeldsen J, Bibby BM, Brock B, Baumgart DC. Vedolizumab Concentrations in the Breast Milk of Nursing Mothers With Inflammatory Bowel Disease. Gastroenterology. 2018 Feb;154(3):752-754.e1. Abstract Full text (link to original source) Full text (in our servers)
  23. 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
  24. Mahadevan U, McConnell RA, Chambers CD. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 2017 Feb;152(2):451-462.e2. Abstract
  25. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  26. 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)
  27. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  28. Chaparro M. [Natural history, complications, safety and pregnancy in inflammatory bowel disease]. Gastroenterol Hepatol. 2015 Sep;38 Suppl 1:20-31. Abstract
  29. Mahadevan U, Matro R. Care of the Pregnant Patient With Inflammatory Bowel Disease. Obstet Gynecol. 2015 Aug;126(2):401-12. Abstract
  30. 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
  31. 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)
  32. 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)
  33. 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)
  34. 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
  35. 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
  36. 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)
  37. 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

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