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CIMZIA during breastfeeding - any human trials completed?

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  • CIMZIA during breastfeeding - any human trials completed?

    Hi - I have been suffering from RA for last 5 years and just delivered our first (boy) without any medications during pregnancy. It has been 2 months since then and i have been exclusively breast feeding (with very little formula) but RA has now come back with force and have had flare ups. The doctor is proposing CIMZIA to "buy time" since i am keen to try and breastfeed for 6 months (4 more months to go ideally) before he puts me back on Enbrel + Meth (this combination has suited me in the past with almost remission) . I reviewed some info on the forum but could not figure out if there was any update from the human trials of CIMZIA on infants who breastfeed in terms of:

    1) Cimzia level that gets passed into the milk; and
    2) whether that could potentially lead to slower growth or other abnormalities (organ issues etc.) in the baby.

    I am mostly concerned about big problems vs. "prone" to more infection so any color would be incredibly helpful. Thanks!

  • #2

    We do have some recent data on Cimzia (Certolizumab). In a recent study in 17 mothers (16 received 200 mg q 2 weeks, and 1 received 400 mg q 4 weeks) receiving certolizumab during breastfeeding.[2] Samples were collected on days 0, 2, 4, 6, 8, 10, 12 across one dosing period. Samples from 4 of 17 subjects had no measurable certolizumab. Thirteen of 17 subjects had exceedingly low but measurable levels in breastmilk. Fifty six percent of samples were below the limit of quantitation. The average daily infant dose was minimal, ranging from zero to 0.0114 mg/kg/day. The RID ranged from zero to 0.31. Median RID was 0.125. These levels in milk are probably too low to produce clinical effects in a breastfed infant.

    I think it is probably safe to use this product in breastfeeding mothers.

    Tom Hale Ph.D.


    • #3
      Thank you Dr. Tom. Just two more questions:
      1. Did you notice any pattern in terms of increased levels for mother(s) who were given 200mg every 2 weeks (dose 1) vs. 400mg every 4 weeks (dose 2)? Just trying to figure out which dose (1 or 2) would lead to less contamination of the breast-milk. It probably depends on the half life of the drug which seems to be 4 weeks so perhaps it does not matter?
      2. Does your assessment of 'probably safe' change (in the first month) if the doctor advises a loading dose of 400mg on week 0, 2, 4, 8 and every 4 weeks from there on?
      Last edited by Harmina; 08-22-2016, 09:14 PM.


      • #4

        1) Doses were mixed ranging from 16 patients on 200 mg Q2 weeks. 1 patient on 400 mg Q 4 weeks. All were at steady state after > 3 doses. Most all of the milk samples were below the limit of detection, which is really low.

        I don't think you need to worry about dose at all.

        2) No. Even at 400 mg the samples were below limit of quantitation.

        All of this should be published in the next month or so as a case report.

        Tom Hale Ph.D.
        Last edited by admin; 08-23-2016, 01:20 PM.


        • #5
          Has any additional research been conducted on the safety of breastfeeding while taking Cimzia since these posts in 2016? Is the drug likely to change from L3 to either L2 or L1? My GI doctor would like for me to switch to Cimzia for treatment of my Crohn's disease, given research indicating probable safety while breastfeeding. My 8 month old daughter's (born premature at 36 weeks- small, but otherwise healthy) pediatrician feels uncomfortable with me continuing to breastfeed if I begin taking the drug, given its classification. I was wondering if there was any additional research already conducted or currently being conducted that could help me reconcile this conflicting medical advice. Thank you!


          • #6

            Yes, we do have some recently published data on Cimzia (certolizumab). Levels in milk were very low and below the limit of detection in most moms milk. I recently changed its risk category to L2. Below are more studies on its use in breastfeeding mothers.

            As an academic, I must disclose that I was involved in the breastfeeding study.

            Tom Hale Ph.D.

            Items: 7

            Select item 288144321.

            Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. ([url][/url])

            Clowse ME, Förger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Toublanc N, Wang M, Hale TW.

            Ann Rheum Dis. 2017 Nov;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384. Epub 2017 Aug 16. PMID: 28814432 Select item 266172142.

            Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. ([url][/url])

            Förger F, Zbinden A, Villiger PM.

            Joint Bone Spine. 2016 May;83(3):341-3. doi: 10.1016/j.jbspin.2015.07.004. Epub 2015 Nov 23. PMID: 26617214

            Select item 298570903.

            Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. ([url][/url])

            Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U.

            Gastroenterology. 2018 Sep;155(3):696-704. doi: 10.1053/j.gastro.2018.05.040. Epub 2018 May 30. PMID: 29857090
            Similar articles ([url][/url])


            • #7
              Thanks for including these references. This is really helpful.

              Will the risk classification be updated in Medications and Mother's Milk for doctors to reference? I ask because it is easier to reference a risk category in conversation with the doctor than the research itself, which certainly gives me greater comfort as I move forward with any decisions about my health and my daughter's health.

              Thanks again


              • #8

                I just changed the Lactation Risk Category to an L2. Should have do so a few months ago but forgot to do so.

                Tom Hale