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Ipilimumab Pregnancy and Breastfeeding Warnings

Ipilimumab is also known as: Yervoy

Ipilimumab Pregnancy Warnings

Ipilimumab has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryofetotoxicity and embryolethality. There are no controlled data in human pregnancy. The manufacturer recommends that ipilimumab should only be used during pregnancy when the potential benefits outweigh the potential risks to the developing fetus.

Human IgG1 is known to cross the placenta; therefore, since ipilimumab is an IgG1, it may be transmitted from the mother to the developing fetus. Intravenous administration of ipilimumab to pregnant cynomolgus monkeys every 21 days from the onset of organogenesis through delivery at doses of 2 to 7 times the usual human dose resulted in severe toxicities including increased incidences of third-trimester abortion, stillbirth, premature delivery, low birth weight, and infant mortality.

Ipilimumab Breastfeeding Warnings

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

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