Pregnancy: There are no adequate data from the use of omidenepag isopropyl in pregnant women. A study in rabbits has shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, Eybelis should be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment.
Breast-Feeding: It is unknown whether omidenepag isopropyl or its metabolites are excreted in human milk. A study in rats has shown omidenepag isopropyl was not detected in their milk after a single subcutaneous administration. When Eybelis is used in breast-feeding women, breast feeding should be weighed, taking into consideration benefits of the therapy and breast-feeding.
Fertility: It is unknown whether omidenepag isopropyl or its metabolites affect fertility in humans. In rats, no treatment-related changes were noted in the parameters on fertility and early embryonic development (see Pharmacology: Toxicology: Preclinical safety data under Actions). Risk benefit should be weighed when considering to use Eybelis while trying to conceive.