Rituxan And Pregnancy: Is It Safe?

Rituximab is a drug used to treat non-Hodgkin lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and other conditions. While it is recommended that women avoid becoming pregnant while taking rituximab, some women may inadvertently become pregnant during or after treatment. Here is an overview of the safety considerations and outcomes associated with rituximab use during pregnancy.

Rituximab is classified as a Pregnancy Category C drug by the US FDA, indicating potential risks to the fetus. Animal studies have shown that rituximab can cause lymphoid B-cell depletion in newborns, and human data suggest it may cause adverse developmental outcomes, including B-cell lymphocytopenia in infants exposed in utero. The manufacturer recommends avoiding rituximab during pregnancy and for 12 months before conception due to concerns about infant B-cell depletion.

Several studies have examined the outcomes of pregnancies with rituximab exposure. One study identified 102 pregnancies with rituximab use within six months of conception, resulting in 78 live births and 12 spontaneous abortions. Another study of 19 women with rituximab exposure during or before pregnancy found no pattern of major structural anomalies or other adverse outcomes. However, three children had major structural defects, and there were two preterm deliveries.

Overall, the available data suggest that rituximab use during pregnancy may be relatively safe, but more research is needed. The studies reported a low rate of adverse pregnancy and infant outcomes, with no consistent pattern of birth defects or pregnancy complications. However, rituximab can cause B-cell depletion in adults, and there have been cases of transient B-cell depletion in newborns exposed to rituximab in utero. Therefore, it is essential to monitor neonatal B-cell levels and long-term immune function in exposed infants.

Rituximab is not recommended during pregnancy, but it may be necessary for some women

Rituximab is a drug used to treat inflammatory illnesses such as rheumatoid arthritis, as well as certain types of lymphoma and leukaemia. It is not recommended for use during pregnancy, and women are advised to use effective contraception while taking the drug and for 12 months after.

However, for women with inflammatory illnesses or blood cancers, it is important that their conditions are well-treated during pregnancy to avoid a flare-up of symptoms and to reduce the chance of certain pregnancy complications. In such cases, the benefits of rituximab may outweigh the risks.

Rituximab has been shown to cause adverse developmental outcomes, including B-cell lymphocytopenia in infants exposed in utero. In animal studies, administration of the drug during the period of organogenesis caused lymphoid B-cell depletion in newborn offspring. There is also a theoretical concern that rituximab could cause depletion of fetal/infant B lymphocytes, increasing the risk of neonatal infection.

Despite these concerns, there is limited data to suggest that rituximab causes an excess of adverse pregnancy or infant outcomes. One study of 74 pregnancies in women with multiple sclerosis showed no increase in adverse perinatal outcomes over expected population rates. Another study of 19 women with exposure to rituximab found no pattern of major structural anomalies or other adverse outcomes.

While rituximab is not recommended during pregnancy, it may be necessary for some women to ensure their condition remains well-controlled and to prevent complications linked to their underlying illness. In such cases, it is important that pregnant women are closely monitored, and that neonatal B-cell levels are checked to ensure the infant's immune system is functioning correctly.

Rituximab can cause adverse effects in infants, including B-cell lymphocytopenia

Rituximab is a drug used to treat inflammatory illnesses and some types of lymphoma and leukaemia. It is also used off-label for multiple sclerosis (MS). It is not recommended for use during pregnancy, but in cases where it is necessary, it can be used if the benefits outweigh the risks.

In another study, neonatal complications did not appear to be elevated, and the most common complication, jaundice, was consistent with the rate in the general population. There were no serious or opportunistic postnatal infections reported, and no cases of B-cell depletion were noted. However, it should be noted that haematological testing for infants was rarely documented in the medical records.

In animal studies, administration of rituximab during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring. Offspring of pregnant animals exposed to rituximab did not exhibit any teratogenic effects but did have decreased lymphoid tissue B cells regardless of the timing of exposure. The B-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum.

Given the known risk of B-cell depletion among adults taking rituximab, there is a theoretical concern that the same depletion could occur among fetuses exposed to this medication in utero. Women who are pregnant or planning to become pregnant should consult their doctor about the risks and benefits of using rituximab.

Women are advised to use contraception while taking rituximab and for 12 months after

Rituximab is a drug used to treat inflammatory illnesses such as rheumatoid arthritis, as well as certain types of lymphoma and leukaemia. It is not recommended for use during pregnancy, and women are advised to use contraception while taking rituximab and for 12 months after. This is because the drug can cause adverse effects on the foetus, including B-cell lymphocytopenia in infants exposed in utero.

Rituximab is a B-cell-depleting drug, and its effects on adults are well-known. It has a long elimination half-life, averaging 18-22 days, and can be detected in peripheral blood beyond 24 weeks after the last infusion in some patients. Peripheral B cells remain depleted for around 6 months after infusion, but B-cell reconstitution is highly variable, and in a small percentage of patients, may not occur for years. Given this, and the fact that the drug can be detected in the serum of infants exposed in utero, women are advised to avoid pregnancy for at least 12 months after their last rituximab dose.

Despite this, some women may become pregnant while taking rituximab or within 12 months of their last dose. In these cases, it is important to note that there is limited data on the effects of rituximab on pregnancy, and the available data is reassuring. One study of 74 pregnancies in women with multiple sclerosis showed no increase in adverse perinatal outcomes over expected population rates. Another study of 19 women who were exposed to rituximab during pregnancy found no evidence of an excess of adverse pregnancy or infant outcomes. No pattern of major structural anomalies or other adverse outcomes was reported in this case series.

However, it is important to note that the available data is limited, and more research is needed to fully understand the risks and benefits of rituximab use during pregnancy. In the meantime, women who are taking rituximab and those who have taken it within the last 12 months should be advised to use effective contraception to avoid unintended pregnancies.

There is limited data on pregnancy outcomes for women taking rituximab

Rituximab is a drug used to treat inflammatory illnesses, such as rheumatoid arthritis, and certain types of lymphoma and leukaemia. It is also used off-label for multiple sclerosis. It is known that rituximab can cause adverse outcomes in infants exposed in utero, including B-cell lymphocytopenia. However, there is limited data on pregnancy outcomes for women taking rituximab.

A systematic review by Das et al. identified 102 pregnancies with rituximab use within 6 months of conception, 78 of which resulted in live births and 12 in spontaneous abortions. The review found no major safety concerns with rituximab use within 6 months of conception. However, the authors noted the need for further research on a larger patient cohort to determine the safety of rituximab during pregnancy.

Another study by Chakravarty et al. analysed 231 pregnancies associated with maternal rituximab exposure. The study found that most of the pregnancies were confounded by concomitant use of potentially teratogenic medications and severe underlying disease. Of the 153 pregnancies with known outcomes, 90 resulted in live births, with 22 infants born prematurely. The study concluded that while there were few congenital malformations or neonatal infections observed, women should continue to be counselled to avoid pregnancy for up to 12 months after rituximab exposure.

A case series by Perrotta et al. examined pregnancy outcomes in 19 women with exposure to rituximab. The study found no pattern of major structural anomalies or other adverse outcomes. However, the authors noted that the sample size was small and that complete data was not available for all participants.

A retrospective analysis by Pendergraft et al. examined eight pregnancies in six women with autoimmune vasculitis who were treated with rituximab. The analysis found that most pregnancies were uneventful, and that rituximab use prior to pregnancy resulted in a low rate of adverse effects. However, the authors noted that further study is needed to determine the perinatal safety of rituximab.

Overall, while there is limited data on pregnancy outcomes for women taking rituximab, the available evidence suggests that rituximab use during pregnancy may be relatively safe. However, due to the limited data and potential risks, women are advised to avoid pregnancy for up to 12 months after rituximab exposure.

Rituximab may be safe to use in later pregnancy

Rituximab is a drug used to treat non-Hodgkin lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and other conditions. While it is recommended that women avoid becoming pregnant while using the drug, some women may inadvertently become pregnant during or after treatment.

Observational studies and case reports have found that rituximab use during pregnancy may be relatively safe, especially in the later stages of pregnancy. However, it is important to note that these studies are limited and more research is needed to fully understand the potential risks.

One study found that among 102 women who became pregnant within six months of rituximab exposure, 78 resulted in live births, and 12 in spontaneous abortions. Another study of 19 women with exposure to rituximab found no pattern of major structural anomalies or other adverse outcomes.

It is important to note that rituximab can cause B-cell depletion in adults and has been detected in cord blood, raising concerns about potential effects on the infant's immune system. However, in the studies mentioned above, no cases of B-cell depletion were reported among the infants, and neonatal complications did not appear to be elevated.

While these findings provide some reassurance, it is important to emphasise that more research is needed to fully understand the safety profile of rituximab during pregnancy. Women who are considering becoming pregnant while using rituximab should consult their healthcare providers to weigh the risks and benefits.

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