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Dosing of SPRAVATO – Partial or Incomplete Administration

Last Updated: 06/12/2024

SUMMARY  

  • SPRAVATO nasal spray is intended for administration by the patient under the supervision of a healthcare professional, using 2 devices (for a 56-mg dose) or 3 devices (for an 84-mg dose), with a 5-minute rest between use of each device to allow medication to be absorbed. The nasal spray device is a single-use device that delivers a total of 28 mg of esketamine in two sprays (one spray per nostril). To prevent loss of medication, do not prime the device before use.1
  • The SPRAVATO device has an indicator window which displays 2 green dots when the device is full, one green dot when one spray has been delivered, and no green dots when the device is empty.1
  • Instruct patient to blow nose before first device only.1
  • If during administration, liquid drips out, dab nose with tissue.1
  • Total esketamine absorption after esketamine administration is a combination of local absorption by the nasal mucosa (major route), as well as by the gastrointestinal tract via swallowing.2
  • No systematically collected clinical data is available on administering a partial/incomplete dose of SPRAVATO or on management of an incomplete dose of SPRAVATO.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENTDrug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 16 May 2024.

References

1 Center for Drug Evaluation and Research. Other Review. NDA 211243 - SPRAVATO (esketamine) - Reference ID: 4398871. 2019- [cited 2024 May 16]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211243Orig1s000OtherR.pdf.  
2 Perez-Ruixo C, Rossenu S, Zannikos P, et al. Population pharmacokinetics of esketamine nasal spray and its metabolite noresketamine in healthy subjects and patients with treatment-resistant depression. Clin Pharmacokinet. 2021;60(4):501-516.