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Sutimlimab Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Feb 1, 2023.

Sutimlimab is also known as: Enjaymo

Sutimlimab Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: No data on use of this drug in pregnant women to inform a drug-related risk.

-Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.

Animal studies have failed to reveal evidence of fetal harm. Animal reproduction studies in pregnant monkeys, did not show any adverse effects on pregnancy or offspring when this drug was administered IV at doses 2 to 3 times the maximum recommended human doses (between 60 and 180 mg/kg/dose). However, this drug was detectable in infants born to the pregnant females exposed to 180 mg/kg/week. 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

Sutimlimab Breastfeeding Warnings

Benefit should outweigh risk.

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

-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-No conclusions can be drawn regarding whether or not this drug is safe for use during breastfeeding.

See references

References for pregnancy information

  1. Product Information. Enjaymo (sutimlimab). Bioverativ Therapeutics Inc. 2022.

References for breastfeeding information

  1. Product Information. Enjaymo (sutimlimab). Bioverativ Therapeutics Inc. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.