Delgocitinib topical Pregnancy and Breastfeeding Warnings

Brand names: Anzupgo

Delgocitinib topical Pregnancy Warnings

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

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.

Animal studies have failed to reveal evidence of adverse developmental effects. Oral administration of this drug to pregnant rats and rabbits during the period of organogenesis did not result in embryofetal toxicity at doses 120 or 193 times, respectively, the maximum recommended human dose (MRHD) based on AUC comparison. However, maternal exposures at significantly higher doses (512 times or greater the MRHD based on AUC comparison) resulted in post-implantation loss, reduced live births, decreased fetal weights, and skeletal variations. There are no controlled data in human pregnancy.

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.

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Delgocitinib topical Breastfeeding Warnings

According to some authorities: Use is considered acceptable.

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

Comments:
-Although the effects on the breastfed child are unknown, no adverse effects are expected as the systemic exposure of this drug in the breastfeeding woman is negligible.
-If used during breastfeeding, avoid direct contact with the nipple or surrounding area after applying the cream to the hands and/or wrists.
-As a precautionary measure, avoid direct contact with infant skin immediately after treatment application.
-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.

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Further information

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