Roflumilast topical Pregnancy and Breastfeeding Warnings

Brand names: Zoryve, Zoryve Foam

Medically reviewed by Drugs.com. Last updated on Nov 28, 2023.

Roflumilast topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
This drug is systemically absorbed after topical application and may result in fetal exposure. As per clinical findings and results from animal studies this drug can cause fetal harm when administered to a pregnant woman.
Do not use this drug during labor and delivery.
In animal studies after oral administration this drug disrupted the labor and delivery process.

Effects of this drug on animal pregnancy after topical administration have not been reported. There are no controlled data in human pregnancy.

Animal studies done during organogenesis showed no fetal structural abnormalities after oral administration, at doses up to 9 times the maximum recommended human dose (MRHD).

This drug caused pre- and post-implantation loss at doses greater than or equal to 3 times the MRHD, stillbirth and decreased pup viability were seen at doses 5 and 15 times the MRHD, respectively.
This drug affected pup post-natal development at doses 15 times the MRHD, also decreased survival, forelimb grip reflex and delayed pinna detachment at doses 29 times the MRHD on a mg/m2 basis.
In animal fertility studies, this drug after oral administration decreased fertility rates in males at doses 9 times the MRHD on a mg/m2 basis.

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

Roflumilast topical Breastfeeding Warnings

Use is not recommended.

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

Excretion into human milk is likely.

When a drug is present in animal milk, it is likely that the drug will be present in human milk. Rats given 1 mg/kg of this drug orally had active ingredient and metabolite concentrations of 0.32 and 0.02 mcg/g respectively in breastmilk after 8 hours.

See references

Further information

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