Filgrastim Pregnancy and Breastfeeding Warnings

Brand names: Neupogen, Nivestym, Releuko, Zarxio

Medically reviewed by Drugs.com. Last updated on Jun 16, 2023.

Filgrastim Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk Summary: There are no adequate studies of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of reduced embryofetal survival and increased abortions at maternally toxic doses (2 to 10 times the recommended human dose). Animal models given this drug during the perinatal period and throughout lactation had pups with delayed external differentiation, growth, and slightly decreased survival rates compared to those not exposed.

There are no controlled data in human pregnancy. Observational studies based on data taken from the Severe Chronic Neutropenia International Registry (SCNIR) found that there were no major differences between pregnant women given this drug and those untreated regarding pregnancy outcomes, newborn complications, and infections.

To monitor the outcomes of pregnant women exposed to Neupogen (R) in the UK, a Pregnancy Surveillance Programme has been established by the manufacturer. Physicians are encouraged to enroll patients via email at gbinfoline@amgen.com.

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.

See references

Filgrastim Breastfeeding Warnings

To monitor the outcomes of breastfeeding women exposed to Neupogen (R) in the UK, a Lactation Surveillance Programme has been established by the manufacturer. Physicians are encouraged to enroll patients via email at gbinfoline@amgen.com.

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some authorities recommend: Caution is recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Other biosynthetic granulocyte colony-stimulating factors (G-CSF) given to breastfeeding women were secreted into breastmilk and were not orally absorbed by neonates.
-Some experts state that treatment should not be held due to breastfeeding.

See references

Further information

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