Spravato Use In Pregnancy & Lactation

Women of childbearing potential: SPRAVATO is not recommended during pregnancy and in women of childbearing potential not using contraception.
Pregnancy: There are no or limited data on the use of esketamine in pregnant women. Animal studies have shown that ketamine, the racemic mixture of arketamine and esketamine, induces neurotoxicity in developing foetuses (see Pharmacology: Toxicology: Preclinical safety data under Actions). A similar risk with esketamine cannot be excluded.
If a woman becomes pregnant while being treated with SPRAVATO, treatment should be discontinued, and the patient should be counselled about the potential risk to the foetus and clinical/therapeutic options as soon as possible.
Breast-feeding: It is unknown whether esketamine is excreted in human milk. Data in animals have shown excretion of esketamine in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from SPRAVATO therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Animal studies showed that fertility and reproductive capacities were not adversely affected by esketamine.