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  • Cimza, Plaquinil

    I have psoratic arthritis and I currently take Plaquinil 200 mg daily, Cimiza 400 mg q monthly for that in addition to carafate and Nexium. I am expecting my first baby in May and would like to breastfeed and was wondering if this was safe.
    Thank you

  • #2
    sthemcc,

    Nexium is rated an L2-no data-probably compatible. Very little is expected to enter breast milk. It is unstable in the stomach of the infant at a low pH, so any passed into the milk would be destroyed in the infants stomach prior to absorption.

    Carafate is rated an L1-no data-compatible. Less than 5% is absorbed orally, so with these plasma levels it is very unlikely to penetrate into breastmilk.

    Plaquinil is rated an L2-limited data-probably compatible. The amount that passes into breast milk is 2.9% of your dose. This medication has a large volume of distribution so milk levels are usually quite low making this medication probably compatible with breastfeeding. Monitor your infant for irritability, insomnia, vomiting, diarrhea, weight gain. With prolonged exposure monitor vision.

    Cimzia is an L3-limited data-probably compatible. This medication has a large molecular weight and is not likely to enter the milk in significant quantities. Animal studies have shown minimal transfer into breast milk and no antibodies were found in the nursing pups, but no human studies have been done. There are no long term data on the safety of using immune modulating medications in breastfeeding mothers so each women needs to understand the risk of using this type of medication. We think the risk is low as long as your infant is not symptomatic. Monitor for fever, frequent infections, feeding/weight gain.

    Sandra Lovato R.N.
    InfantRisk Center
    806-352-2519

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    • #3
      Carafate is rated an L1-no data-compatible. Less than 5% is absorbed orally, so with these plasma levels it is very unlikely to penetrate into breastmilk.

      Comment


      • #4
        , This is a great article. It gave me a lot of useful information. thank you very much. Link profile: <a href= http://phongkhamdakhoathegioi.vn/kham-ngua-bao-quy-dau-tai-tphcm.html> http://phongkhamdakhoathegioi.vn/kham-ngua-bao-quy-dau-tai-tphcm.html</a>

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        • #5
          I'm pregnant again. I'm still on Cimza and Plaquinil. With my last my husband and I decided not to breast fed because the evidence was limited. I have seen this has recently been updated to include CImiza as L2. I was wondering if there was any other update on these meds as I am thinking about breast feeding with this baby, unless disease worsens and doc wants to restart the Arvara I was on prior to trying to become pregnant with my first.
          Thanks

          Comment


          • #6
            Sthemcc:

            If Cimzia works for you, it is the best choice. We just finished publishing pregnancy and breastfeeding data and they are good. Levels in infant in utero are low, and levels in milk are low as well.

            Tom Hale





            Ann Rheum Dis. ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=cimzia+milk%2Chuman+hale#[/url]) 2017 Nov;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384. Epub 2017 Aug 16. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study.

            Clowse ME ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Clowse%20ME%5BAuthor%5D&cauthor=true&cauthor _uid=28814432[/url])1, Förger F ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=F%C3%B6rger%20F%5BAuthor%5D&cauthor=true&cau thor_uid=28814432[/url])2, Hwang C ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Hwang%20C%5BAuthor%5D&cauthor=true&cauthor_u id=28814432[/url])3, Thorp J ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Thorp%20J%5BAuthor%5D&cauthor=true&cauthor_u id=28814432[/url])4, Dolhain RJ ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Dolhain%20RJ%5BAuthor%5D&cauthor=true&cautho r_uid=28814432[/url])5, van Tubergen A ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=van%20Tubergen%20A%5BAuthor%5D&cauthor=true& cauthor_uid=28814432[/url])6, Shaughnessy L ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Shaughnessy%20L%5BAuthor%5D&cauthor=true&cau thor_uid=28814432[/url])7, Simpson J ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Simpson%20J%5BAuthor%5D&cauthor=true&cauthor _uid=28814432[/url])7, Teil M ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Teil%20M%5BAuthor%5D&cauthor=true&cauthor_ui d=28814432[/url])8, Toublanc N ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Toublanc%20N%5BAuthor%5D&cauthor=true&cautho r_uid=28814432[/url])9, Wang M ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Wang%20M%5BAuthor%5D&cauthor=true&cauthor_ui d=28814432[/url])7, Hale TW ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=Hale%20TW%5BAuthor%5D&cauthor=true&cauthor_u id=28814432[/url])10. Author information ([url]https://www-ncbi-nlm-nih-gov.ezproxy.ttuhsc.edu/pubmed/?term=cimzia+milk%2Chuman+hale#[/url])

            Abstract

            BACKGROUND:

            Women with chronic inflammatory diseases face uncertainty regarding the safety of biologics during breast feeding. CRADLE was the first industry-sponsored study to evaluate certolizumab pegol (CZP) concentrations in human breast milk and estimate average daily infant dose (ADID) of maternal CZP. METHODS:

            CRADLE (NCT02154425 ([url]http://clinicaltrials.gov/show/NCT02154425[/url])) was a pharmacokinetic study of lactating mothers receiving CZP. After ≥3 CZP doses, breast milksamples were collected across one dosing period (14 days for 200 mg every 2 weeks [Q2W]; 28 days for 400 mg every 4 weeks [Q4W]). Optimal analytical methods were developed to determine CZP and polyethylene glycol (PEG) levels in breast milk. ADID and relative infant dose (RID) were estimated. Safety events in mothers and infants were assessed. RESULTS:

            19 CZP-treated mothers were screened; 17 entered the sampling period: 16 on 200 mg Q2W, 1 on 400 mg Q4W. 77/137 (56%) breast milk samples had no measurable CZP. For 4/17 mothers, all samples were below the lower limit of quantification (LLOQ). Estimated ADID was 0-0.0104 mg/kg/day; median RID: 0.15%. PEG was undetectable in 134/137 samples (results could not be determined in three samples). Infants of CZP-exposed mothers had a safety profile consistent with that of unexposed similar-age infants. CONCLUSION:

            When quantifiable, CZP concentrations were <3× LLOQ (<1% plasma concentration observed with therapeutic dose), indicating no/minimal CZP transfer from plasma to breast milk. RID was 0.15% of maternal dose; <10% is considered unlikely to be of clinical concern. No PEG transfer was observed. CZP absorption by infants via breast milk is unlikely due to its low oral bioavailability and Fc--free molecular structure. These findings are reassuring and support continuation of CZP treatment during breast feeding. TRIAL REGISTRATION NUMBER:

            NCT02154425 ([url]http://clinicaltrials.gov/show/NCT02154425);[/url] Results.

            © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. KEYWORDS:

            Anti-tnf; Autoimmune Diseases; Rheumatoid Arthritis; Spondyloarthritis PMID: 28814432

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            • #7
              Thank you so much. And thank for the article information. Pulling off PubMed now.

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