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  • Stelara

    Is it safe to continue breastfeeding a 6 month old infant while starting treatment for moderate-severe plaque psoriasis with Stelara? If so, should the mother pump and discard for a specific amount of time following the injection?

  • #2
    Dear Csnyder323,

    Ustekinumab (Stelara) is a human IgG1 monoclonal antibody used in the treatment of severe plaque psoriasis and rheumatoid arthritis. According to the manufacturer, ustekinumab is excreted in the milk of lactating monkeys. While some IgG is excreted into human milk, levels of ustekinumab are probably exceedingly low. It is not known if ustekinumab is absorbed systemically after ingestion; however, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts.

    Although the molecular weight of this medication is very large and the amount in breastmilk is very low, there are no long term data concerning the safety of using immune modulating medications in breastfeeding mothers. Further there are current data that suggest that some IgG drugs do transfer into milk, and perhaps the breastfed infant. Therefore, some caution is recommended and each woman should understand the benefits and risk of using this type of medication in lactation.

    I would not suggest any pumping or discarding since this medication has a very long half life of 14.9 - 45.6 days.

    Hope this helps!! For further questions please contact us at the InfantRisk Center on 806-352-2519.

    Tassneem Abdel Karim, MD
    InfantRisk Center.

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    • #3
      Are any of the biologics for the treatment of psoriasis considered safe in breastfeeding (i.e enbrel, humira, stelara)? Do you consider one to be "the best choice"?

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      • #4
        Dear Csnyder323,

        Enbrel (Etanercept) is a good choice, it is a large molecular IgG protein and is too large to enter the milk compartment. Three studies in breastfeeding women confirm that levels in milk are exceedingly low. No untoward effects were reported in any of the infants. Etanercept was undetectable in infant plasma.

        For more information, contact the InfantRisk Center at (806)352-2519.

        Tassneem Abdel Karim, MD
        InfantRisk Center

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        • #5
          My baby is 3 months old. Dermatologist wants to start me on stelara. There is no long term research but states it is safe. Do you agree at 3 months?

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          • #6
            Hi, thanks for your post.

            Unfortunately, there still really isn't any satisfactory information one way or the other on this medication. Stelara was only approved in the US about 5 years ago and quality post-marketing studies in breastfeeding women simply don't exist. What's more, basic science research on the behavior of monoclonal antibodies (like Stelara) is somewhat conflicted as to how they behave in the breastmilk and how they are absorbed from the gut. That makes it difficult to make educated guesses about the breastfeeding risk.

            We know for sure that Stelara is excreted into the breastmilk of monkeys and it is reasonable to assume that it may be present in human milk at low levels. Whether that is hazardous to a baby is not known, but it is unlikely that it is absorbed in the infants gut.

            You and your doctor will have to weigh that unknown risk against the very real benefit of breastfeeding your baby. However, we presently have a lot of breastfeeding mothers using monoclonal antibodies of one sort or another and we have no reports of complications.

            Please call us at the InfantRisk Center if this has not completely answered your question. (806)352-2519

            -James Abbey, MD
            and
            -Thomas W. Hale, Ph.D.

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