Eltrombopag Pregnancy and Breastfeeding Warnings

Eltrombopag is also known as: Promacta

Eltrombopag Pregnancy Warnings

Pregnancy Registry: A pregnancy registry has been established to collect information about the effects of eltrombopag during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the PROMACTA pregnancy registry by calling 1-888-825-5249.

Eltrombopag has been assigned to pregnancy category C by the FDA. There are no adequate and well-controlled studies of eltrombopag use in pregnancy. In animal reproduction and developmental toxicity studies, there was evidence of embryolethality and reduced fetal weights at maternally toxic doses. Eltrombopag should be used in pregnancy only when benefit outweighs risk.

Eltrombopag Breastfeeding Warnings

There are no data on the excretion of eltrombopag into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from eltrombopag, a decision should be made whether to discontinue nursing or to discontinue eltrombopag taking into account the importance of eltrombopag to the mother and the known benefits of nursing.

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