USE OF TRASTUZUMAB IN PREGNANCY

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(Date of issue: July 2015, Version: 2)

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.

Summary

Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). Trastuzumab is indicated in the treatment of HER2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer; where tumours have either HER2 overexpression or HER2 gene amplification.

There are very limited data on use of trastuzumab in human pregnancy and an evidence-based assessment of risk to the fetus with use in pregnancy is thus not currently possible. No congenital malformations were observed following first trimester exposure to trastuzumab, however data is limited to only 12 case reports. Oligohydramnios or anhydramnios has been observed in >60% of case reports documenting exposure during pregnancy, and 100% of pregnancies where exposure continued after early pregnancy. Effects on fetal growth in utero, spontaneous abortion, preterm delivery, stillbirth, neonatal complications, neurodevelopment  and carcinogenicity risk in offspring have not been studied.

Enhanced monitoring of maternal cardiac function and amniotic fluid volume is recommended if trastuzumab treatment during pregnancy is deemed necessary. Other risk factors may also be present in individual cases which 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 UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to be sure you are using the most up-to-date version.

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.