Granix Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not Assigned.
Risk Summary: Limited published data on use during pregnancy are insufficient to inform a drug-associated risk.
Animal studies have revealed evidence of embryolethality, fetotoxicity, and spontaneous abortions at doses that produced maternal toxicity. 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.
See references
Granix Breastfeeding Warnings
Other recombinant granulocyte colony stimulating factor (G-CSF) products are poorly secreted in breast milk, and G-CSF is not orally absorbed by neonates.
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comment: The effects in the nursing infant are unknown.
See references
