Last update Feb. 19, 2021

Nivolumab

Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Human immunoglobulin G4 (IgG4) monoclonal antibody indicated in certain cases of melanoma, Hodgkin's lymphoma, lung cancer and other carcinomas.
Intravenous administration every 2 to 4 weeks.

We did not find published data regarding the excretion of this substance through breast milk at the time this last update was completed.

It´s very high molecular weight (> 100,000 Da) makes it very unlikely to pass into breast milk in a significant quantity, since molecules of more than 800 - 1,000 Da do not pass into breast milk (Hale, Almas 2016, Anderson 2016).

Null or negligible passage into breast milk of similar monoclonal antibodies, such as adalimumab, belimumab, certolizumab, golimumab, infliximab, ipilimumab, natalizumab, rituximab, tocilizumab and ustekinumab has been confirmed (Bar-Gil 2021, LaHue 2020, Ciplea 2020, Saito 2020, 2019 and 2018, Krysko 2019, Whittam 2019, Klenske 2019, Matro 2018, Anderson 2018, Bragnes 2017, Witzel 2014, Ross 2014, Fritzsche 2012).

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).

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:

  • Maternal Cancer ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)

Alternatives

We do not have alternatives for Nivolumab.

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.

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.

Other names

Nivolumab in other languages or writings:

Groups

Nivolumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Nivolumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 143.597 daltons
VD 0.1 l/Kg
Tmax 1 - 4 hours
500 - 641 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. 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 March 15, 2022 Full text (link to original source)
  3. 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
  4. 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
  5. 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)
  6. EMA. Nivolumab. Drug Summary. 2020 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. Ciplea AI, Langer-Gould A, de Vries A, Schaap T, Thiel S, Ringelstein M, Gold R, Hellwig K. Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder. Neurol Neuroimmunol Neuroinflamm. 2020 Apr 23;7(4). pii: e723. Abstract Full text (link to original source)
  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. EMA. Nivolumab. Ficha ténica. 2020 Full text (in our servers)
  11. 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
  12. 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
  13. 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
  14. 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)
  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. 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
  17. 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
  18. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  19. 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
  20. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  21. 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)
  22. 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)
  23. 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
  24. 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
  25. 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)
  26. 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)
  27. 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)
  28. 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
  29. 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)
  30. 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
  31. 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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