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  • Aldara/Imiquimod

    Do we have any information on this medication use in breastfeeding? I cannot find it in the current Medications in Mother's Milk.

    In this case, the nursling is 16 months if that makes a difference in the answer.

    Thank you!

  • #2
    Thankful:

    At present we do not have any data on the transfer of Imiquimod (Aldara) into human milk. From its absorption topically, plasma levels in mothers are incredibly low, about 0.323 ng/mL. IF all of this got into milk (which is totally unlikely), then the infant would get about 323 nanograms/liter of milk (only 50% orally bioavailable), which would be far too low to produce clinical effects in an infant.

    Imiquimod has been used in young children. In a study researching the pharmacokinetics of imiquimod in children, serum levels of this drug were shown to be extremely low. After administration of 12.5-37.5 mg imiquimod each day to children aged 2-12, it was found that the median maximum concentration was ≤0.5 ng/mL for single doses and ≤1.0 ng/mL for multiple doses. One outlier was reported with concentrations as high as 9.7 ng/mL. Children in this study were all treated for molluscum contagiosum with 5% imiquimod cream. Amounts given to each child varied based on the weight of the subject and extent of disease.

    I doubt that the use of Aldara in breastfeeding mothers will produce clinical effects in the infant. But please remember, this is still just supposition on my part from the published kinetics of this drug.



    Tom Hale Ph.D.

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    • #3
      Dear thankful,

      There are no data on the transfer of imiquimod into human milk. There are two studies that have found blood levels to be low when imiquimod was applied topically. If the blood levels are low, then the breastmilk levels likely would be low. Since the breastfeeding child is 16 months old, and the amount of breastmilk consumed would also be low compared to a six month old child; the topical use of imiquimod would probably be compatible with breastfeeding. The breastfeeding infant should be observed for nausea, vomiting, and poor feeding.

      Sincerely,
      Cindy Pride, MSN, CPNP
      TTUHSC InfantRisk Center

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      • #4
        Aldara;imiiquimod

        Hi there,
        I will be putting a very small dab of cream on my nose for 6 weeks. It says imiquimod has a weight of 240.3 and I can't figure out its protein thing.(i have a small basal cell carcinoma)
        I breastfeed my 2 year old, quite a lot at night and day still. Do you have any idea how much this could effect him?
        Looking at the weight it could transfer more readily I believe?
        from Belle chch nz

        Comment


        • #5
          Belle:

          As you can see above, we don't know how much if any Imiquimod gets into milk. But following topical use, the maternal plasma levels are really low, hence milk levels should be much much lower. With a 2 year old, I really doubt the child would receive much at all.

          Remember at this stage of lactation, the volume of milk you are producing is probably quite low, hence the dose of this drug is quite low as well.

          Tom Hale Ph.D.

          Comment


          • #6
            Has there been any further research on Aldara/Imiquimod. I will begin treatment in January and my baby will be 7 months old. She has started on solids so breastmilk is not her only source of nutrition. However, I would like to understand if there are any known risks should I continue to provide breastmilk or if there is a time of day where the concentration would be higher and should be avoided. Thank you

            Comment


            • #7
              Hi, thanks for your post.

              There has not been any new research published on this subject in the last 5 years. The risk to your baby is theoretically very small, but ultimately unknown. This medication is routinely used in young children with no ill effects. Because it is slowly released from the skin, there is no way to reduce exposure to the infant using a breastfeeding schedule. As with all topical medications, make sure your baby is not directly exposed to medication residues on your hands, breasts, or clothing.

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

              -James Abbey, MD

              Comment


              • #8
                Hello, I will be breastfeeding my newborn, and am also considering using Imiquimod, but as a cervical ointment for HPV. Would the absorption be the same as topical treatment for skin, or would it be greater (and therefore the risk to newborn) considering it will be applied internally?

                Comment


                • #9
                  Bananamoore:

                  Absorption or dose largely depends on the surface area treated. This product is commonly used topically for various skin conditions and used on large surface areas of the body. I'd think the dose on the cervix would be quite minimal...thus the dose is probably low. Below is some data for you to peruse.

                  I don't think it would be much of a problem in your situation.

                  Tom Hale Ph.D.



                  Imiquimod has been used in young children. In a study determining the pharmacokinetics of imiquimod in children, serum levels of this drug were shown to be extremely low. After administration of 12.5-37.5 mg imiquimod each day to children aged 2-12, it was found that the median maximum concentration in serum was ≤ 0.5 ng/mL for single doses and ≤1 ng/mL for multiple doses. One outlier was reported with concentrations as high as 9.7 ng/mL. Children in this study were all treated for molluscum contagiosum with 5% imiquimod cream. Amounts given to each child varied based on the weight of the subject and extent of disease.[3]

                  While there are no data on the excretion of imiquimod into human milk, milk levels will likely be far lower than 323 ng/L, which would be far too low to produce clinical effects in an infant. The manufacturer recommends that caution be used when administering imiquimod to nursing women.


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