Romiplostim Pregnancy and Breastfeeding Warnings

Romiplostim is also known as: Nplate

Romiplostim Pregnancy Warnings

FDA Pregnancy Category : C Use is not recommended unless the benefit outweighs the risk to the developing fetus.

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 use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-800-77-AMGEN (1-800-772-6436). 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.

Romiplostim Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

The excretion of romiplostim into human milk is unknown. However, romiplostim is comprised of human immunoglobulin and 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.

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