Cimzia and Pregnancy

[berriboo]

Hi! I last wrote in about breastfeeding and Cimzia, and received good feedback, thankyou! Now I am pregnant with #2 and was wondering what information you can give me about it during pregnancy. My doctor is recommending I go off it and go back on prednisone (even though I was under the assumption he put me on Cimzia in the first place because he knew my partner and I were trying to conceive). I expressed my concern to him that I had insomnia with the prednisione and that I am worried about that, going back to work and caring for a 1 year old. He has given me 2 weeks to make my decision so I'm trying to get as much information as I can.

Thanks for your time.

Lacey

[admin]

berriboo:

Thus far, it does not seem that Cimzia (certolizumab) is highly teratogenic. However, thus far no randomized, well-controlled studies have been done in human pregnancy. In animal studies, no increase in the risk of congenital anomalies was seen. Fetal concentrations of the antibody were found to be less than 0.3% of the maternal concentrations, indicating poor placental transfer. Reproduction in offspring were also within nl limits. (Reprotox)Infliximab (drug same class) transfers in greater amount in third trimester. There are abnormality observed in fetus from one case of 22 years old women treated with certolizumab during third and fisrt trimester.


--------------From package insert: -----------------

Pregnancy Category B – Because certolizumab pegol does not cross-react with mouse or rat TNFα, reproduction studies were performed in rats using a rodent anti-murine TNFα pegylated Fab' fragment (cTN3 PF) similar to certolizumab pegol. Reproduction studies have been performed in rats at doses up to 100 mg/kg and have revealed no evidence of impaired fertility or harm to the fetus due to cTN3 PF. There are, however, no adequate and well-controlled studies of CIMZIA in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


Best of luck with your pregnancy.



Tom Hale Ph.D.

[berriboo]

Thanks for the information and the quick response.

[shahzaib85]

I really appreciate that you took all this time to try and help us.Your work is carry the information to the other people.

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[DavidMiller1]

There are abnormality observed in fetus from one case of 22 years old women treated with certolizumab during third and fisrt trimester.

[Haroon]

Yes you are absolutely right I am also thinking like you.