Sarilumab Pregnancy and Breastfeeding Warnings

Brand names: Kevzara

Medically reviewed by Drugs.com. Last updated on Feb 8, 2024.

Sarilumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Monoclonal antibodies are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Women of childbearing potential should use effective contraception during and up to 3 months after treatment.
-In response to antigen challenge, Immunoglobulin G levels may be reduced in the fetus or infants of treated mothers.
-It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

Animal studies revealed no evidence of embryotoxicity or fetal malformations at exposures up to approximately 84 times the maximum recommended human dose (MRHD). The literature suggests that inhibition of IL-6 signaling may interfere with cervical ripening, dilatation and myometrial contractile activity leading to potential delays of parturition. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused, or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Sarilumab Breastfeeding Warnings

Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Maternal IgG is present in human milk.
-Discontinue drug or nursing taking into consideration importance of drug to mother.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low, and absorption is unlikely because it is probably destroyed in the infant GI tract. Some experts say that if the mother requires this drug, it is not a reason to discontinue breastfeeding.

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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