In pregnant rats, subcutaneous administration of this drug from organogenesis to lactation, failed to show any embryofetal or postnatal development toxicity at doses up to 7 times clinical exposure. In pregnant rabbits, this drug caused embryofetal lethality and reduced fetal weight when administered subcutaneously during organogenesis at approximately 6 times the exposure at the clinical dose. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Data from published literature with use of other recombinant human granulocyte colony-stimulating factor (rhG-CSF) products in pregnant women have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

See references

Safety has not been established.

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

Comments:
-Endogenous granulocyte colony stimulating factor (G-CSF) is present in human milk.
-Other recombinant G-CSF products are poorly secreted in breast milk, and are not orally absorbed by neonates.
-The effects in the nursing infant are unknown.

See references