Nipocalimab Pregnancy and Breastfeeding Warnings

Brand names: Imaavy

Medically reviewed by Drugs.com. Last updated on Jun 2, 2025.

Nipocalimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug can harm a developing fetus.
-A pregnancy safety study is available.
-Monoclonal antibody placental transfer increases as pregnancy progresses, with the largest amount transferred during the third trimester.
-This drug reduces maternal serum immunoglobulin G concentration and delay its placental transfer, potentially lowering infant passive immunity for 6 months or more.
---Consider monitoring for serious infections.
---Effectiveness of vaccine may be reduced.
---Consider risks and benefits before administering live vaccines to infants exposed to this drug in utero.
-If used during pregnancy, or if a patient becomes pregnant during treatment, healthcare providers should report exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com

Animal studies have revealed evidence of fetal harm. This drug did not show direct adverse effects on fetal development in animals. However, it caused placental ischemia, which was associated with fetal loss and reduced immunoglobulin G levels in the offspring at both 100 and 300 mg/kg doses. 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

Nipocalimab Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Yes

Comments:
-This drug is excreted in human colostrum and breastmilk.
-There is limited information on the effects of this drug on the breastfed infants, and no data are available regarding effects on milk production.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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