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.
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