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Sarilumab Pregnancy and Breastfeeding Warnings

Brand names: Kevzara

Medically reviewed by Last updated on Feb 8, 2024.

Sarilumab Pregnancy Warnings

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 and dilatation and myometrial contractile activity leading to potential delays of parturition. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

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.

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

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

Risk Summary: The limited human data with this drug in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. 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. Levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers.

-A pregnancy exposure registry is available.

See references

Sarilumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

-The effects in the nursing infant are unknown.
-Maternal IgG is present in human milk.

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 if this drug is required by the mother, it is not a reason to discontinue breastfeeding.

See references

References for pregnancy information

  1. Product Information. Kevzara (sarilumab). sanofi-aventis. 2017.

References for breastfeeding information

  1. Product Information. Kevzara (sarilumab). sanofi-aventis. 2017.

Further information

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