USE OF XONVEA IN PREGNANCY

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(Date of issue: April 2021, 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.

A corresponding patient information leaflet on Xonvea is available at www.medicinesinpregnancy.org.

Summary

Pyridoxine/doxylamine combination products are licensed for the treatment of nausea and vomiting in pregnancy (NVP). In the UK, a delayed-release preparation is marketed as Xonvea®, in the US as Diclegis®, and in Canada as Diclectin®. Xonvea® contains the antihistamine doxylamine succinate 10mg and pyridoxine hydrochloride (vitamin B6) 10mg.

Rates of infant congenital malformation following in utero exposure to products containing this combination of drugs have been widely studied, with the majority of analyses providing no evidence of an increased risk. Data relating to other pregnancy outcomes are scarce.

Exposure to pyridoxine/doxylamine (Xonvea®) at any stage in pregnancy is not regarded as medical grounds for termination of pregnancy, nor does it require any additional fetal monitoring. However, other risk factors may 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 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.