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USE OF RITUXIMAB IN PREGNANCY

Date of issue: March 2026, Version: 4

A corresponding patient information leaflet on USE OF RITUXIMAB IN PREGNANCY is available.

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, pemphigus vulgaris, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. It is also used off-label in the treatment of lupus nephritis, neuromyelitis optica and multiple sclerosis. Rituximab acts via CD20⁺ B-cell depletion.

Rituximab is not expected to cross the placenta during the first trimester; therefore, direct teratogenic effects are not anticipated. Data specific to rituximab use during pregnancy are limited to case reports and uncontrolled case series, one disproportionality analysis and a meta-analysis of women treated during and prior to pregnancy. There are extremely limited data available for first trimester-exposed pregnancies (n=16), but these cases and data from a larger number of preconceptual exposures (<6 months prior to conception) mainly describe healthy outcomes. Although the uncontrolled studies and case reports do not indicate that rituximab use during pregnancy is associated with adverse pregnancy outcomes, the data are too limited to rule out potential risks.

Maternal autoimmune and inflammatory conditions are associated with certain adverse pregnancy outcomes, including miscarriage, preterm delivery and low infant birth weight. Maintaining adequate control of the maternal condition may help reduce the risk of these adverse pregnancy outcomes.

Rituximab exposure in utero has been demonstrated to deplete neonatal B-cells. There are currently insufficient data regarding the effect of in utero rituximab exposure on the neonatal/infant immune system. Guidance from Public Health England (PHE) (now the UK Health Security Agency (UKHSA)) [issued 2017] specifies that live vaccines should not be used until the infant is 6 months old following in utero biologic immunosuppressant exposure.

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 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.

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 UKTIS.org to ensure you are using the most up-to-date version.