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Eltrombopag Pregnancy and Breastfeeding Warnings

Eltrombopag is also known as: Promacta

Eltrombopag Pregnancy Warnings

Animal studies have revealed evidence of embryolethality and reduced fetal weights at maternally toxic doses; however, animal studies may not have revealed in full the potential of teratogenicity, since eltrombopag is not pharmacologically active in rats or rabbits. There are no controlled data in human pregnancy. 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. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US 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.

Eltrombopag should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Use of eltrombopag is not recommended in women of childbearing potential not using adequate contraception.

Eltrombopag Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue eltrombopag, taking into account the importance of eltrombopag to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

In lactating rats, eltrombopag was detected 10 days post-partum, showing the potential for transfer during lactation.

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