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Rituximab Pregnancy and Breastfeeding Warnings

Rituximab is also known as: Rituxan

Rituximab Pregnancy Warnings

Reproduction studies in cynomolgus monkeys at maternal exposures similar to human therapeutic exposures showed no evidence of teratogenic effects. There are no controlled data in human pregnancy. There are no data on whether rituximab can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. Rituximab was detected postnatally in the serum of infants exposed in-utero. Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. Rituximab is only recommended for use in pregnant women if the potential benefit to the mother justifies the potential risk to the fetus. The manufacturer has recommended that individuals of childbearing potential use effective contraceptive methods during treatments and for up to 12 months following therapy with rituximab. There has been a case reported of a pregnant woman who used rituximab in combination with CHOP chemotherapy for aggressive B-cell non-Hodgkin's lymphoma. She delivered a healthy girl via caesarean section in the thirty-fifth week of her pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Use rituximab only if clearly needed and benefit outweighs risk.

Rituximab Breastfeeding Warnings

Use of rituximab is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

Because human IgG is excreted into human milk and the potential for absorption and immunosuppression in the infant are unknown, breast-feeding is not recommended until circulating drug levels are no longer detectable.

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