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Esketamine Pregnancy and Breastfeeding Warnings

Esketamine is also known as: Spravato

Medically reviewed by Drugs.com. Last updated on Feb 18, 2020.

Esketamine Pregnancy Warnings

Parenteral: Use is recommended only if clearly needed and the benefit outweighs the risk.
Nasal: Use is not recommended.

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. When used in animal models, the racemic mixture of this drug and arketamine has resulted in fetal harm.

Comments:
-Use of adequate methods of contraception should be encouraged.
-Patients of pregnancy potential should consider pregnancy planning and prevention.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential harm to the fetus.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of delayed sensorimotor development, skeletal malformations, and neuronal apoptosis at intranasally administered doses 0.3 times the maximum recommended human dose. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to antidepressants, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by contacting the National Pregnancy Registry for Antidepressants by calling 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

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

Esketamine Breastfeeding Warnings

Animal models have revealed evidence that N-methyl-D-aspartate (NMDA) receptor blocker exposure during rapid brain growth or synaptogenesis resulted in neuronal and oligodendrocyte cell loss and alterations in synaptic morphology and neurogenesis. Changes are believed to correlate with exposure during the third trimester and through the first several months of life; however, this may extend to approximately age 3.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the effects on milk production.
-Animal models have revealed evidence of neurotoxicity.
-Some experts state that single IV doses may not affect breastfed infants, but use of repeated nasal doses should be avoided.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Spravato (esketamine)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. "Product Information. Spravato (esketamine)." Janssen Pharmaceuticals, Titusville, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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