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Filgrastim Pregnancy and Breastfeeding Warnings

Filgrastim is also known as: Neupogen, Zarxio

Filgrastim Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C

In animal studies at doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies or reproductive/developmental toxicity observed at doses 10 times the recommended human dose (based on body surface area). 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

Filgrastim Breastfeeding Warnings

Granulocyte colony-stimulating factor (G-CSF) is a normal component of breastmilk; however, the excretion of this drug in breastmilk or its effects on breastfed infants has not been studied. Limited data indicate that it is poorly excreted into breastmilk and undetectable by 3 days after an injection. Some experts recommend withholding breastfeeding for this period of time; however, it has been safely given orally to neonates and is not orally absorbed by neonates, so any drug that is excreted into milk is unlikely to adversely affect the breastfed infant.

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.

See references

References for pregnancy information

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

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Neupogen (filgrastim)." Amgen, Thousand Oaks, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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