Ozanimod and 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 and unlikely to reach the breastmilk in large amounts, it has a slow clearance and long half-life and is potentially toxic to the breastfed infant. Some guidelines recommend avoiding ozanimod during breastfeeding because of a lack of data;[1-4] however, the manufacturer's labeling does not recommend against the use of ozanimod in breastfeeding. Until more data become available, ozanimod should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Drug levels in milk and infant serum

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.

Alternative drugs to consider

(Multiple Sclerosis) Glatiramer, Immune Globulin, Interferon beta, Methylprednisolone, Natalizumab, Ocrelizumab, Ofatumumab, Peginterferon beta; (Ulcerative Colitis) Adalimumab, Azathioprine, Budesonide, Certolizumab Pegol, Infliximab, Mesalamine, Olsalazine, Prednisone, Sulfasalazine

References

1. Torres J, Chaparro M, Julsgaard M, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis 2023;17:1–27.36005814 PubMed
2. Capone F, Albanese A, Quadri G, et al. Disease-modifying drugs and breastfeeding in multiple sclerosis: A narrative literature review. Front Neurol 2022;13:851413.35493841 PubMed
3. Shipley J, Beharry J, Yeh W, et al. Consensus recommendations on multiple sclerosis management in Australia and New Zealand: part 2. Med J Aust 2025;222:365–71.39923190 PubMed
4. Mahadevan U, Seow CH, Barnes EL, et al. Global consensus statement on the management of pregnancy in inflammatory bowel disease. Clin Gastroenterol Hepatol 2025;23 (11S):S1–S60.40874901 PubMed