Last update Jan. 25, 2023

Romosozumab

Low Risk

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

It is a humanized  IgG-2 monoclonal antibody that inhibits sclerostin, a mediator of bone remodeling. It decreases bone resorption and therefore increases bone mineralization. Indicated for patients with osteoporosis at high risk of fracture. Subcutaneous administration once a month for 12 months. Calcium and vitamin D supplements should be given during treatment.

At the date of the last update we did not find any published data on its excretion in breast milk.

Its very high molecular weight make it highly unlikely that significant quantities will pass into breast milk.

Due to its protein nature, it is degraded in the gastrointestinal tract, and is not absorbed as such (virtually zero oral bioavailability), which makes it difficult or prevents its passage into infant plasma from ingested breast milk, except in premature infants and in the immediate neonatal period, in which there may be greater intestinal permeability.

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. 

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

Expert authors consider that the use of monoclonal antibodies during breastfeeding is safe or very likely to be safe (Hale, 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).

Monitor the possibility of hypocalcemia.

Alternatives

We do not have alternatives for Romosozumab.

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.

Other names

Romosozumab in other languages or writings:

Group

Romosozumab belongs to this group or family:

Tradenames

Main tradenames from several countries containing Romosozumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 145.900 daltons
VD 3.92 o 0.06 ? l/Kg
Tmax 120 hours
307 hours

References

  1. EMA. Romosozumab. Ficha técnica. 2019 Full text (in our servers)
  2. 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)
  3. Amgen. Romosozumab. Drug Summary. 2019 Full text (in our servers)
  4. Anderson PO. Drug Treatment of Rheumatoid Arthritis During Breastfeeding. Breastfeed Med. 2018 Nov;13(9):575-577. Abstract
  5. 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)
  6. Anderson PO. Monoclonal Antibodies. Breastfeed Med. 2016 Apr;11:100-1. Abstract
  7. 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)
  8. 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
  9. 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)

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