Romiplostim Pregnancy and Breastfeeding Warnings

Brand names: Nplate

Romiplostim Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: Insufficient data exist to inform a drug-associated risk of adverse developmental outcomes.

Comments: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed reductions in maternal body weight and increased postimplantation loss at doses 5 times the maximum human dose (MHD). There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-800-772-6436 (US) or 1800 803 638 (freecall within AU).

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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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. Breastfeeding women receiving this drug are encouraged to enroll in a lactation surveillance program by calling 1800 803 638 (freecall within AU).

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: This drug is made up of fragment crystallizable (Fc) domain of human immunoglobulin G1 (IgG1). Human IgG is excreted in human milk but data suggest that breast milk antibodies do not enter neonatal or infant circulation in substantial amounts.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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