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Romiplostim Pregnancy and Breastfeeding Warnings

Romiplostim is also known as: Nplate

Medically reviewed on Jun 8, 2017

Romiplostim Pregnancy Warnings

UK: Use is not recommended.
AU and US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Encourage use of adequate methods of contraception.

Animal studies have revealed thrombocytosis, postimplantation loss, and increased pup mortality. 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 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.

See references

Romiplostim Breastfeeding Warnings

UK and US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
AU: Caution is recommended; 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.

See references

References for pregnancy information

  1. "Product Information. Nplate (romiplostim)." Amgen USA, Thousand Oaks, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Nplate (romiplostim)." Amgen USA, Thousand Oaks, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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