USE OF RITUXIMAB 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.

A corresponding patient information leaflet on rituximab use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Rituximab is a chimeric human-murine IgG1 monoclonal antibody produced by recombinant DNA technology administered in the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. Rituximab acts via CD20+ B-cell depletion.

Data specific to rituximab use during pregnancy are limited to case reports and a case series. As such, there is insufficient evidence to assess whether risk for spontaneous abortion, congenital malformation, birth weight, intrauterine death or adverse neurodevelopmental outcome is increased following exposure in utero.

Maternal autoimmune/inflammatory conditions are known to be associated with certain adverse pregnancy outcomes such as spontaneous abortion, preterm delivery and low birth weight, therefore, ensuring adequate control of the maternal condition may theoretically decrease the risk of certain adverse pregnancy outcomes.

There is theoretical concern that the use in pregnancy of immunosuppressant antibodies such as rituximab, which actively crosses the placenta, could result in immunosuppression and increased risk of neonatal infection. It may therefore be advisable to delay administration of live vaccines to infants who have been exposed in utero on a precautionary basis, however no recommendations regarding duration of the delay are available for rituximab. 

Due to the lack of data, additional fetal monitoring may be warranted on a case-by-case basis. 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 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.