Spravato Use In Pregnancy & Lactation

Pregnancy: Esketamine (Spravato) is not recommended during pregnancy. The risks of Esketamine (Spravato) during pregnancy have not been studied. Human data in pregnant women during clinical trials with esketamine exposure are too limited to be conclusive. Animal studies with ketamine, the racemic mixture of arketamine and esketamine, show evidence of developmental neurotoxicity (see as follows). The potential for esketamine to have neurotoxic effects on fetuses cannot be excluded. To avoid exposing the fetus to esketamine, women of reproductive potential should be advised to use highly effective contraception during and up to 6 weeks after the last treatment with Esketamine (Spravato). If a woman becomes pregnant while being treated with Esketamine (Spravato), treatment with esketamine should be discontinued and the patient should be counseled about the potential risk to the fetus and clinical/therapeutic options as soon as possible.
Ketamine, the racemic mixture of arketamine and esketamine, administered intravenously at high anesthetic dose levels to female rats in the second trimester of pregnancy caused neuronal cell abnormalities in the brains of their offspring which showed behavioral changes and impaired memory up to young adult age. When female monkeys were treated intravenously with ketamine at high anesthetic dose levels in the third trimester of pregnancy, neuronal cell death was observed in the brains of their fetuses. Ketamine‑induced neuronal cell death was also observed with early postnatal intraperitoneal or subcutaneous treatment of rat and mice pups, a period of rapid brain growth. This period of brain development translates into the third trimester of human pregnancy. In embryo‑fetal developmental toxicity studies in rats, nasally‑administered ketamine did not induce adverse findings in the offspring. Skeletal malformations were found in the offspring of rabbits nasally treated with ketamine. It cannot be excluded that esketamine induces neurotoxicity in developing fetuses (see Pharmacology: Toxicology: Non‑Clinical Information under Actions).
Breast‑feeding: Esketamine (Spravato) is not recommended in women who are breast‑feeding. The risks of Esketamine (Spravato) during breast‑feeding have not been studied in humans. There are no data available to assess the effects of esketamine on human milk production, its presence in human milk, or effects on the breastfed infant. Esketamine is expected to be excreted to human milk based on published data showing presence of ketamine in cow milk in cows exposed to intravenously‑administered ketamine. Advise patients either not to undergo therapy with Esketamine (Spravato) while breast‑feeding or discontinue breast‑feeding if treatment with Esketamine (Spravato) is initiated, taking into account the importance of the drug to the mother. (See Pharmacology: Toxicology: Non‑Clinical Information under Actions).