Mirikizumab Pregnancy and Breastfeeding Warnings

Brand names: Omvoh

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Mirikizumab Pregnancy Warnings

According to some authorities: Use should be avoided as a precautionary measure.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Monoclonal antibodies can cross the placenta, causing immunosuppression in the fetus exposed in utero.
-The levels of this drug in infant serum at birth and its duration of persistence after birth are unknown.
-According to some authorities, women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.
-A pregnancy exposure registry is available.

Animal studies have failed to reveal evidence of maternal and developmental toxicities. In pregnant cynomolgus monkeys administered this drug during organogenesis, no developmental or maternal toxicity occurred at a dose 69 times the maximum recommended human dose. However, embryo/fetal loss was higher in the control group but was within the range of historical control data. There are no controlled data in human pregnancy.

This drug may interfere with an infant's immune response to infections; therefore, risks and benefits should be considered prior to administering live vaccines to infants exposed to this drug in utero. A minimum wait of 2 months after birth should be considered before administering vaccines because of the long half-life (9.3 days) of the product.

There are risks of adverse pregnancy outcomes associated with increased disease activity in women with inflammatory bowel disease.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers are encouraged to register patients and pregnant women are encouraged to register themselves.).

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Mirikizumab Breastfeeding Warnings

Caution is recommended, especially while breastfeeding newborn or preterm infants.

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

Comments:
-There are no data on the presence of this drug in human milk, its effects on the breastfed infant, or on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and potential adverse effects on the infant.
-Maternal immunoglobulin G antibodies are known to be excreted in human milk during the first few days after birth; a risk to the breastfed infant cannot be excluded.
-The amount of this drug in breast milk is likely low due to its large protein structure; it is likely to be partially destroyed in the infant's gastrointestinal tract and undergo minimal absorption.
-According to some experts, waiting at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

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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