Deucravacitinib Pregnancy and Breastfeeding Warnings

Brand names: Sotyktu

Medically reviewed by Drugs.com. Last updated on Nov 29, 2022.

Deucravacitinib Pregnancy Warnings

According to some authorities: As a precaution, use should be avoided during pregnancy.

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

Risk summary: Insufficient data are available on use of this drug in pregnant women to inform a drug-related risk; animal studies did not reveal evidence of embryofetal toxicity.

Comments:
-A pregnancy exposure registry is available.

Animal studies have failed to reveal evidence of reproductive toxicity. There were no detectable embryolethal or teratogenic effects in any animal species at doses up to 266 times the maximum recommended human dose. Adverse outcomes related to maternal toxicity, postnatal development, reproductive performance, or fertility were not observed in animal studies. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Patients and health care providers are encouraged to report pregnancies to the Bristol-Myers Squibb Adverse Event reporting line at 1-800-721-5072.

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

Deucravacitinib Breastfeeding Warnings

If this drug is needed by the mother of an older infant, it is not a reason to discontinue nursing; however, an alternative drug may be preferred, particularly while breastfeeding newborn or preterm infants, until more data are available.
-According to some authorities: 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:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-When a drug is excreted in animal milk, it is likely to be present in human milk.
-The amount of drug in human milk is expected to be low due to high plasma protein binding (greater than 80%); however, this drug is well absorbed orally.

See references

Further information

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