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Ensifentrine Pregnancy and Breastfeeding Warnings

Brand names: Ohtuvayre

Medically reviewed by Drugs.com. Last updated on Jul 23, 2024.

Ensifentrine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Animal studies have failed to reveal evidence of fetal harm with maternal exposures; however, animal studies have revealed evidence of increased pre and postimplantation loss and decreased live embryos in untreated female rats after mating with male rats treated at exposures 30 times the exposure at the maximum recommended human daily inhalation dose (MRHDID). After inhalation administration to pregnant rats and rabbits at exposures up to 79 and 9 times the exposure at the MRHDID, respectively, no adverse developmental effects were observed. 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.

See references

Ensifentrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

See also

References for pregnancy information

  1. (2024) "Product Information. Ohtuvayre (ensifentrine)." Verona Pharma

References for breastfeeding information

  1. (2024) "Product Information. Ohtuvayre (ensifentrine)." Verona Pharma

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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