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Abatacept Pregnancy and Breastfeeding Warnings

Abatacept is also known as: Orencia

Abatacept Pregnancy Warnings

Abatacept has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Abatacept crosses the placenta. There are no controlled data in human pregnancy. Abatacept is only recommended for use during pregnancy when benefit outweighs risk.

Rats treated with abatacept every three days during early gestation throughout the lactation period showed no adverse effects in the offspring at doses up to 45 mg/kg (3-fold a human 10 mg/kg dose based on AUC). At a dose of 200 mg/kg (11-fold a human 10 mg/kg dose based on AUC) alterations of immune function consisted of a 9-fold increase in the T-cell dependent antibody response in female pups and inflammation of the thyroid in one female pup out of 10 males and 10 females evaluated. It has not been determined if these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to abatacept. Healthcare professionals are encouraged to register patients and patients may also enroll themselves by calling 1-877-311-8972.

Abatacept Breastfeeding Warnings

There are no data on the excretion of abatacept into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, including possible effects on the developing immune system, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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