Dosing and Administration SMDD
SPRAVATO® (esketamine) dosing and administration
TRD=treatment-resistant depression in adults.
MDSI=depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
8 doses over 4 weeks to treat depressive symptoms in adults with MDSI1
• All patients in the clinical studies received comprehensive standard-of-care (SOC) treatment, including an initial inpatient hospitalization and a newly initiated or optimized oral antidepressant (AD) therapy (AD monotherapy or AD plus augmentation) as determined by the investigator
• After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated
• Dosage may be reduced to 56 mg twice weekly based on tolerability
Depressive symptoms in adults with MDD with acute suicidal ideation or behavior administration
SPRAVATO® should be self-administered by the patient under the supervision of a healthcare provider in a certified SPRAVATO® treatment center.1
Read the full Dosing & Administration Guide before training and supervising patients.
Please see “Dosing and Administration” and “Instructions for Use” in the full Prescribing Information.
Post-administration observation and discharge
Healthcare providers are required to observe patients for at least 2 hours.
• Because of the possibility of delayed or prolonged sedation or dissociation in some cases, patients should be monitored by a healthcare provider for at least 2 hours following each treatment
Patients will require transportation from the treatment center.
• Caution patients that SPRAVATO® may impair their ability to drive, and not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep
1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceutials, Inc. July 2020.
2. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Prefer and Adherence. 2012;6:369-388.