USE OF EVEROLIMUS IN PREGNANCY

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(Date of issue: March 2017, Version: 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 everolimus use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Everolimus is a tyrosine kinase inhibitor indicated (by specific brand) for: (i) the treatment of advanced renal cell carcinoma, neuroendocrine tumours of pancreatic, gastrointestinal, or lung origin, and hormone receptor-positive advanced breast cancer; (ii) the prevention of graft rejection following renal, liver, or heart transplantation; (iii) the treatment of subependymal giant cell astrocytoma and renal angiomyolipoma associated with tuberous sclerosis complex.

The data relating to human gestational everolimus exposure are extremely limited and consist of case reports of six pregnancies exposed throughout. Due to the absence of controlled studies assessing the rates of adverse pregnancy outcomes following gestational everolimus exposure, it is not currently possible to quantify any risk. Pregnant women or those planning a pregnancy using everolimus should be made aware of this lack of data.

Due to the unknown effects of everolimus on a developing fetus, gestational exposure may be regarded as medical grounds for additional fetal monitoring, including detailed ultrasound scans and regular assessment of fetal growth. In pregnant women in whom use of everolimus is indicated, other factors, including the effects of the underlying maternal condition, 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.
                      
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.