Daxas Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing age should be advised to use an effective method of contraception during treatment. Roflumilast is not recommended in women of childbearing potential not using contraception.
Pregnancy: There are limited amount of data from the use of roflumilast in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Roflumilast is not recommended during pregnancy.
Roflumilast has been demonstrated to cross the placenta in pregnant rats.
Breastfeeding: Available pharmacokinetic data in animals have shown excretion of roflumilast or its metabolites in milk. A risk to the breastfed infant cannot be excluded. Roflumilast should not be used during breast-feeding.
Fertility: In a human spermatogenesis study, roflumilast 500 micrograms had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period.