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: No data available on use of this drug in pregnant patients to inform a drug-related risk. Use of other filgrastim products have not established associations between use during pregnancy and birth defects, miscarriage, and/or adverse fetal/maternal effects.

Comment: A pregnancy registry in the UK is available.

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.

To monitor the outcomes of pregnant patients exposed to Neulasta (R) in the UK, a Pregnancy Surveillance Programme has been established by the manufacturer. Physicians are encouraged to enroll patients via email at [email protected].

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

To monitor the outcomes of breastfeeding patients exposed to Neulasta (R) in the UK, a Lactation Surveillance Programme has been established by the manufacturer. Physicians are encouraged to enroll patients via email at [email protected].

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.

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

Comments:
-Other recombinant granulocyte colony-stimulating factor (G-CSF) products are poorly secreted in breast milk, and G-CSFs are not orally absorbed by neonates.
-The effects in the nursing infant are unknown.
-A lactation surveillance programme in the UK is available.

See references