J&J Medical Connect
SPRAVATO®

(esketamine)

This information is intended for US patients and caregivers to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended to promote the use of our products, nor to provide medical advice.

Why is there a Risk Evaluation and Mitigation Strategy (REMS) Program with SPRAVATO?

Last Updated: 08/06/2024

summary

Here is a passage from the SPRAVATO MEDICATION GUIDE which may be helpful to address your question:

Why is there a Risk Evaluation and Mitigation Strategy (REMS) Program with SPRAVATO?

SPRAVATO Risk Evaluation and Mitigation Strategy (REMS)

  • Because of the risks for sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) Program.1
  • SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program. Patients treated in outpatient healthcare settings (e.g. medical offices and clinics) must be enrolled in the program.1

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest use in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for SPRAVATO.1

 

References

1 SPRAVATO (esketamine) nasal spray [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf.