USE OF CICLOSPORIN IN PREGNANCY

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(Date of issue: February 2017, Version: 2.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on ciclosporin use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Ciclosporin (cyclosporin, cyclosporine, cyclosporine A) is a calcineurin inhibitor used systemically for graft rejection prophylaxis and management, and in the treatment of ulcerative colitis, rheumatoid arthritis, atopic dermatitis, psoriasis, nephrotic syndrome and endogenous uveitis. It is also used topically as an eye drop solution for severe keratitis in adults with dry eye disease.

The available data concerning the safety of maternal ciclosporin use in human pregnancy mainly consist of uncontrolled case series which describe the pregnancy outcomes of more than 1,000 women with solid organ transplants. These data are potentially confounded by reporting bias, effects of the underlying or associated maternal medical conditions, and other maternal therapies on the developing fetus. A small number of controlled studies are also available which collectively report the outcomes of approximately 600 exposed pregnancies. There are no pregnancy exposure data concerning topical administration of ciclosporin.

Although the available data are considered confounded, there is currently little evidence that use of ciclosporin during pregnancy increases the risk of congenital malformation. Increased rates of preterm delivery and intrauterine growth restriction have been identified among women receiving systemic treatment. It is, however, uncertain as to whether these findings are due to in utero ciclosporin exposure alone, fetal effects of the underlying maternal condition, or a combination of the two. The currently available data do not suggest an increased risk of spontaneous abortion, intrauterine death, neonatal complications, or offspring neurodevelopmental impairment following maternal ciclosporin use in pregnancy.

Exposure to ciclosporin at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. Regular clinical review and monitoring of maternal whole blood ciclosporin concentration is recommended both during and after pregnancy due to the risk of subtherapeutic or toxic blood concentrations as a consequence of the pharmacokinetic changes which may be associated with pregnancy. However, other risk factors present in individual cases may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Close monitoring of the maternal graft function and immunosuppressive status, with regular observations of the maternal obstetric condition and fetal growth is advised.          
            
This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.