Sutimlimab Pregnancy and Breastfeeding Warnings

Brand names: Enjaymo

Medically reviewed by Drugs.com. Last updated on Feb 1, 2023.

Sutimlimab Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

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

Comments:
-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. Pregnant monkeys were administered IV doses (60 and 180 mg/kg/dose) once a week from gestation day 20 to parturition (about 21 doses) resulting in exposures 2 to 3 times the human exposures at the maximum recommended doses (based on AUC); this drug was detectable in infants born to pregnant females exposed to 180 mg/kg/week. No adverse effects on pregnancy or offspring development were observed. 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

Until more data are available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Safety has not been established.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-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.
-The effects of local gastrointestinal exposure and limited systemic exposure to this drug in the nursing infant are unknown.
-Maternal immunoglobulin G (IgG) is present in human milk.
-According to some experts, waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

Because this drug is a large protein molecule (molecular weight of 147 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

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

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