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Baricitinib Pregnancy and Breastfeeding Warnings

Baricitinib is also known as: Olumiant

Medically reviewed by Last updated on Jul 13, 2020.

Baricitinib Pregnancy Warnings

Use is contraindicated.

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

Risk Summary: The limited human data on use of this drug in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. In animal, oral administration to pregnant animals at exposures equal to and greater than approximately 20 and 84 times the maximum
recommended human dose (MRHD), respectively, resulted in reduced fetal body weights, increased embryolethality, and dose-related increases in skeletal malformations. No developmental toxicity was observed.

-The Janus kinase (JAK) inhibitors/signal transducers and activators of transcription (STAT) pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development.
-Women of childbearing potential should be encouraged to use adequate methods of contraception during and for at least one week after therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. This drug may have an adverse effect on bone development in utero at higher dosages. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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

Baricitinib Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Olumiant (baricitinib)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. "Product Information. Olumiant (baricitinib)." Lilly, Eli and Company, Indianapolis, IN.

Further information

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