Axatilimab Pregnancy and Breastfeeding Warnings

Brand names: Niktimvo

Medically reviewed by Drugs.com. Last updated on Mar 3, 2025.

Axatilimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Human immunoglobulin G can cross the placenta; this drug has the potential to be transmitted from the mother to the developing fetus.
-Pregnant women should be apprised of the potential harm to the fetus.
-Women of childbearing potential should be advised to use effective contraception during treatment and for 30 days after the last dose.

Animal studies have not been reported. There are no controlled data in human pregnancy.

Pregnancy maintenance and fetal immune protection or development may be compromised by this drug based on its primary mechanism of action. Targeted mutation of colony stimulating factor-1 receptors (CSF-1R) or CSF-1 in animal models resulted in prenatal and perinatal death, deficits in growth, and pleiotropic impact on multiple organ systems, including skeletal and reproductive systems.

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

Axatilimab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 30 days after the last dose.

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

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-Maternal immunoglobulin G is known to be present in human milk.
-Because this drug is a large protein molecule (molecular weight of 150 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

See references

Further information

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