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Pegfilgrastim Pregnancy and Breastfeeding Warnings

Pegfilgrastim is also known as: Fulphila, Neulasta

Medically reviewed on November 13, 2017

Pegfilgrastim Pregnancy Warnings

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

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

Comment:
-Some manufacturers have surveillance programs for pregnant women who are receiving this drug. Consult the manufacturer product information for further detail.

This drug was embryotoxic and increased pregnancy loss in animal studies at cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Pegfilgrastim Breastfeeding Warnings

AU, US: Caution is recommended.
UK: 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

Comments:
-Other recombinant G-CSF products are poorly secreted in breast milk, and G-CSF is not orally absorbed by neonates.
-The effects in the nursing infant are unknown.
-Some manufacturers have surveillance programs for nursing mothers who are receiving this drug. Consult the manufacturer product information for further detail.

See references

References for pregnancy information

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

Further information

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

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