Ozanimod use while Breastfeeding

Summary of Use during Lactation

Although ozanimod and its active metabolites are highly bound in maternal plasma and unlikely to reach the breastmilk in large amounts, it is potentially toxic to the breastfed infant. Because there is no published experience with ozanimod during breastfeeding, expert opinion generally recommends that the closely related drug fingolimod should be avoided during breastfeeding, especially while nursing a newborn or preterm infant.[1-7] Some guidelines recommend avoiding ozanimod during breastfeeding because of a lack of data;[8,9] however, the manufacturer's labeling does not recommend against the use of ozanimod in breastfeeding.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Multiple Sclerosis) Glatiramer, Immune Globulin, Interferon Beta; (Ulcerative Colitis) Adalimumab, Azathioprine, Budesonide, Certolizumab Pegol, Infliximab, Mesalamine, Olsalazine, Prednisone, Sulfasalazine

References

1.

Bove R, Alwan S, Friedman JM, et al. Management of multiple sclerosis during pregnancy and the reproductive years: A systematic review. Obstet Gynecol 2014;124:1157-68. [PubMed: 25415167]

2.

Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler 2013;19:835-43. [PubMed: 23319073]

3.

Houtchens MK, Kolb CM. Multiple sclerosis and pregnancy: Therapeutic considerations. J Neurol 2013;260:1202-14. [PubMed: 22926165]

4.

Almas S, Vance J, Baker T, et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int 2016;2016:6527458. [PMC free article: PMC4757692] [PubMed: 26966579]

5.

Kaplan TB. Management of demyelinating disorders in pregnancy. Neurol Clin 2019;37:17-30. [PubMed: 30470273]

6.

Dobson R, Dassan P, Roberts M, et al. UK consensus on pregnancy in multiple sclerosis: 'Association of British Neurologists' guidelines. Pract Neurol 2019;19:106-14. [PubMed: 30612100]

7.

Selinger C, Laube R, Limdi JK, et al. Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel. Therap Adv Gastroenterol 2024;17:17562848241299737. [PMC free article: PMC11558739] [PubMed: 39539488]

8.

Torres J, Chaparro M, Julsgaard M, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis 2023;17:1-27. [PubMed: 36005814]

9.

Capone F, Albanese A, Quadri G, et al. Disease-modifying drugs and breastfeeding in multiple sclerosis: A narrative literature review. Front Neurol 2022;13:851413. [PMC free article: PMC9051389] [PubMed: 35493841]

Substance Name

Ozanimod

CAS Registry Number

1306760-87-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Immunosuppressive Agents

Sphingosine 1 Phosphate Receptor Modulators