Last update: Dec. 17, 2018

Natalizumab

Low Risk for breastfeeding


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

Recombinant humanized IgG4k monoclonal antibody that blocks the human integrin alpha-4 subunit making it difficult for T lymphocytes to pass through the meninges. Its use is approved in the treatment of severe forms of multiple sclerosis (EMA 2017) and in Crohn's disease when resistant to other treatments (Yarur 2013, FDA 2012).

Its very high molecular weight explains the small or zero transfer into milk observed (Hainke 2015, Baker 2015). Of three mothers in whom the concentration of natalizumab in breast milk was measured, detectable levels only appeared in two. With these measurements, expert authors have calculated a relative dose for the infant of no concern, around 1.7% or, if the maximum peak is considered, 5.3%.

But in addition, its low oral bioavailability would hinder its transfer into the infant's plasma via ingested breast milk because, due to its protein nature, it degrades in the gastrointestinal tract, and is not absorbed (Cree 2013), except in premature infants and the immediate neonatal period where there may be greater intestinal permeability.

Despite the low excretion in breast milk and the lack of intestinal absorption by the infant, due to the long elimination half-life and the limitation of the number of available reports, opinions among experts are divided between those who do not recommend it (Mahadevan 2017), those who think that it is probably compatible (Almas 2016, Baker 2015, Briggs 2017) and those who have not expressed an opinion due to lack of sufficient studies (Hainke 2015, Damas 2015, Cree 2013, Houtchens 2013, Yarur 2013, Mahadevan 2011) , with experts being more in favor of discouraging it in Europe than in the USA (Alroughani 2016).

Other monoclonal antibodies similar to natalizumab, such as adalimumab, infliximab and certolizumab, are considered low risk and probably compatible with breastfeeding (Damas 2015, van der Woude 2010).


See below the information of these related products:

Alternatives

We do not have alternatives for Natalizumab.

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, 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.

Group

Natalizumab belongs to this group or family:

Tradenames

Main tradenames from several countries containing Natalizumab in its composition:

Pharmacokinetics

Variable Value Unit
Bioavailability 0 %
Molecular weight 150.000 daltons
VD 0,08 l/Kg
T1/2 264 hours
Theoretical Dose 0.14 (0,07 - 0,43) mg/Kg/d
Relative Dose 1,7 ? %

References

  1. 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)
  2. EMA. Natalizumab (Tysabri). Ficha técnica. 2017 Full text (in our servers)
  3. EMA. Natalizumab (Tysabri). Drug Summary. 2017 Full text (in our servers)
  4. Mahadevan U, McConnell RA, Chambers CD. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease. Gastroenterology. 2017 Abstract
  5. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. 11th edition (acces on line) 2017
  6. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016 Abstract Full text (link to original source) Full text (in our servers)
  7. Alroughani R, Altintas A, Al Jumah M, Sahraian M, Alsharoqi I, AlTahan A, Daif A, Dahdaleh M, Deleu D, Fernandez O, Grigoriadis N, Inshasi J, Karabudak R, Taha K, Totolyan N, Yamout BI, Zakaria M, Bohlega S. Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks. Mult Scler Int. 2016 Abstract Full text (link to original source) Full text (in our servers)
  8. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  9. Hainke U, Sehr T, Eisele JC, Thomas K, Ziemssen T. Natalizumab: Passage into breast milk and neonatal blood. Mult Scler. 2015;23:690. Abstract EP1324 2015 Full text (link to original source) Full text (in our servers)
  10. Baker TE, Cooper SD, Kessler L, Hale TW. Transfer of natalizumab into breast milk in a mother with multiple sclerosis. J Hum Lact. 2015 Abstract
  11. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Abstract Full text (in our servers)
  12. Houtchens MK, Kolb CM. Multiple sclerosis and pregnancy: therapeutic considerations. J Neurol. 2013 Abstract
  13. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Abstract Full text (link to original source) Full text (in our servers)
  14. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013 Abstract Full text (link to original source) Full text (in our servers)
  15. Mahadevan U, Cucchiara S, Hyams JS, Steinwurz F, Nuti F, Travis SP, Sandborn WJ, Colombel JF. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: pregnancy and pediatrics. Am J Gastroenterol. 2011 Abstract
  16. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)

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