SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding the use of IMAAVY during pregnancy and/or lactation.
• In clinical studies evaluating the use of IMAAVY in patients with generalized Myasthenia Gravis (gMG), women of childbearing potential were required to have a negative serum pregnancy test at Day 1 prior to administration of any study intervention.^1-3 

PRESCRIBING INFORMATION

USE IN SPECIFIC POPULATIONS

PREGNANCY

Risk Summary

• There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.⁴ 

Clinical Considerations - Fetal/Neonatal Adverse Reactions

• Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Because IMAAVY reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more; therefore:⁴ 
  • Monitor for the development of serious infection. Effectiveness of vaccines may be reduced. Consider the risks and benefits prior to administering live vaccines to infants exposed to IMAAVY in utero.

LACTATION

Risk Summary

• Nipocalimab-aahu is excreted in human colostrum and breastmilk based on limited data from an investigational study of 13 pregnant women administered nipocalimab-aahu during pregnancy where colostrum and breastmilk was assessed in the first 8 days after birth.⁴ 
• There are insufficient data on the effect of IMAAVY in the breastfed infant. There are no data on the effect of nipocalimab-aahu on milk production.⁴ 
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IMAAVY, and any potential adverse effects on the breastfed infant from IMAAVY, or from the underlying maternal condition.⁴ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 February 2025.