Baricitinib Pregnancy and Breastfeeding Warnings

Brand names: Olumiant

Baricitinib Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

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

Risk summary: Based on animal data, this drug may cause fetal harm. Insufficient human data available on use of this drug in pregnant women to inform a drug-related risk; no human data available on chronic exposure of this drug throughout pregnancy.

Comments:
-The Janus kinase (JAK)/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.
-Pregnancy planning and prevention should be considered for patients of childbearing potential.
---According to some authorities: Patients of childbearing potential should be advised to avoid becoming pregnant/use effective contraception during therapy and for at least 1 week after the last dose.
-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.
-Pregnancies should be reported to Eli Lilly and Company at 1-800-545-5979.
-There are risks to the mother and fetus associated with rheumatoid arthritis in pregnancy; the risks/benefits of chronic use of this drug during pregnancy should be considered.

Animal studies have revealed evidence of embryofetal toxicity, embryolethality, and teratogenicity. In pregnant rats dosed orally during organogenesis, this drug was teratogenic (skeletal malformations) at exposures equal to or greater than about 11 times the maximum recommended human dose (MRHD); no developmental toxicity was observed at an exposure about 2 times the MRHD. In pregnant rabbits dosed orally during organogenesis, reduced fetal body weights, embryolethality (consisting of increased postimplantation loss due to elevated incidences of both early and late resorptions), and skeletal malformations were observed with maternal toxicity at an exposure about 46 times the MRHD; no developmental toxicity was observed at an exposure about 7 times the MRHD. Animal studies indicate that this drug may have an adverse effect on bone development in utero at higher dosages. There are no controlled data in human pregnancy.

Published data suggest that increased disease activity is associated with risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) infants, and small for gestational age at birth.

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

An alternate agent is preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug and for 4 days after the last dose.
-According to some authorities: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-According to most sources, patients should not breastfeed while taking this drug.
-The effects in the nursing infant are unknown.

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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