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, renal angiomyolipoma, and refractory seizures associated with tuberous sclerosis complex.
The data relating to human gestational everolimus exposure are extremely limited, consisting of case reports of eight pregnancies. While all reported pregnancies resulted in live-born, non-malformed infants, in the absence of controlled studies it is not currently possible to quantify the risk of adverse pregnancy outcome following gestational everolimus exposure. Pregnant women or those planning a pregnancy using everolimus should be offered specialist review so that an individualised assessment of the possible risks and benefits of switching or continuing their medication can be discussed.
Due to the unknown effects of everolimus on a developing fetus, gestational exposure may be regarded as medical grounds for additional fetal monitoring, including regular assessment of fetal growth and wellbeing. 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 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 NHS health care professionals who are logged in.
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.