Romiplostim Pregnancy and Breastfeeding Warnings

Romiplostim is also known as: Nplate

Romiplostim Pregnancy Warnings

Romiplostim has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of thrombocytosis, postimplantation loss, and an increase in mortality. There are no controlled data in human pregnancy. Romiplostim should only be given during pregnancy when benefits outweigh risks.

A pregnancy registry has been established to collect information about the effects of romiplostim use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the romiplostim pregnancy registry by calling 1-877-romiplostim1 (1-877-675-2831).

Romiplostim Breastfeeding Warnings

There are no data on the excretion of romiplostim into human milk. However, human IgG is excreted into human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from romiplostim, a decision should be made whether to discontinue nursing or to discontinue romiplostim, taking into account the importance of romiplostim to the mother and the known benefits of nursing.

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