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Gilenya, an oral pill for MS

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  • Gilenya, an oral pill for MS

    Hello. I am a IBCLC and Accredited LLLL who is working with a mother with mild MS. Her nursing toddler is 2 and she is asking me whether or not a drug called Gilenya is considered compatible with breastfeeding. On the lactmed search, all I could find was info on Fingolimod which was inconclusive. I also couldn't find any info in Meds and Mom's Milk on either of these 2 meds.

    Could someone help me find more info?
    Thank you!
    Karen Urick
    Kansas City, MO

  • #2
    Dear Karen,
    The active ingredient in Gilenya is fingolimod hydrochloride (0.5mg). It is unknown if Gilenya passes into human milk, but based on its molecular weight it is likely to transfer. Further, studies in rats show that it transfers into rat milk. It is reported that Gilenya takes about 2 months to be completely eliminated from the body, has a high oral bioavailability (93%), and a half life of 6-9 days. All of these may be concerning for use in a breastfed infant. Unfortunately, the data we have at this time is limited and we cannot comment on its safety during breastfeeding. This drug was rated an L4 by Dr. Hale due to its adverse side effects and is not recommended for use while breastfeeding.
    Maria Milla, MD
    InfantRisk Center


    • #3

      My wife has MS and we both know that my wife should not feed our baby during taking Gilenya, but because our baby was to young so my wife decid to stop the Gilenya and go back to breastfeeding the baby, so her what happen:
      1- my wife took one Gilenya 0.5mg per day for two days only
      2- she stop the Gilenya and wait for 24 hours then she clean her breast from the old mile using the pump and after feed the baby with breastfeeding for one and a half day only (1.5 days).

      Can you please tel me what do, and what will happen to our baby ?

      Best Regards



      • #4
        Dear Yasin,

        Gilenya (fingolimod) stays in the body for a long period of time. The half-life (time it takes for half of the medication to be eliminated) is 6 to 9 days so it takes about 2 months for the drug to be fully eliminated from mother's body. The drug lowers immunity by affecting white blood cells called lymphocytes. Gilenya also has the potential to decrease the heart rate, and increase liver enzyme levels. We do not have data on how much fingolimod passes into breastmilk. Based on the kinetics of the drug, the amount is likely low. We do not recommend use of this medication during breastfeeding due to the potential risk to the infant. You should notify your pediatrician about your infant's exposure to the medication and discuss what follow up measures need to be done. Let me know if you have further questions.

        Cindy Pride, MSN, CPNP
        TTUHSC InfantRisk Center