Although fingolimod and its active metabolite 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 fingolimod during breastfeeding, expert opinion generally recommends that it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant.[1-6] However, the manufacturer's labeling does not recommend against its use 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.
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]
Substance Identification
Substance Name
Fingolimod
CAS Registry Number
162359-55-9
Drug Class
Breast Feeding
Lactation
Immunosuppressive Agents
Sphingosine 1 Phosphate Receptor Modulators
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.