Spravato (esketamine) is a prescription nasal spray. Find official patient monitoring forms, REMS enrollment applications, and device instruction manuals here.
SPRAVATO® (esketamine) CIII nasal spray is a prescription medicine used along with an antidepressant taken by mouth to treat adults with treatment-resistant depression.
Due to risks of sedation and dissociation, it is only available through a restricted program called the SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy). Here, healthcare professionals, pharmacies, and patients can access vital documentation including Healthcare Setting Enrollment Forms, Patient Monitoring Forms, and comprehensive Instructions for Use for the nasal spray device.
Latest manuals from manuals+ curated for this brand.
Common questions about manuals, registration, and support for this brand.
Facilities must complete the Outpatient Healthcare Setting Enrollment Form, available online at www.SPRAVATOrems.com, or by faxing the paper form to the REMS program at 1-877-778-0091.
The patient self-administers the nasal spray under the direct supervision of a healthcare provider. Patients should recline their head at 45 degrees, insert the tip straight into the nostril, close the opposite nostril, and breathe in through the nose while pushing the plunger.
A healthcare provider must monitor every patient for at least 2 hours following the administration of SPRAVATO to check for resolution of sedation and dissociation, as well as any changes in vital signs.
Healthcare providers should report suspected adverse events or product quality complaints to Janssen at 1-800-JANSSEN (1-800-526-7736) or to the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.