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A treatment session consists of nasal administration of Esketamine (Spravato) and post‑administration observation under the supervision of a healthcare professional.
Esketamine (Spravato) is for nasal use only. 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, the device should not be primed before use. It is intended for administration by the patient under the supervision of a healthcare professional, using 1 device (for a 28 mg dose), 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.
Blood pressure assessment before and after treatment: Assess blood pressure prior to dosing with Esketamine (Spravato) (see Precautions).
If baseline blood pressure is elevated (e.g., >140 mmHg systolic, >90 mmHg diastolic), consider the risks of short term increases in blood pressure and benefit of Esketamine (Spravato) treatment (see Precautions). Do not administer Esketamine (Spravato) if an increase in blood pressure or intracranial pressure poses a serious risk (see Contraindications).
After dosing with Esketamine (Spravato), reassess blood pressure at approximately 40 minutes and subsequently as clinically warranted.
If blood pressure is decreasing and the patient appears clinically stable, the patient may leave at the end of the post-dose monitoring period; if not, continue to monitor (see Precautions).
Since some patients may experience nausea and vomiting after administration of Esketamine (Spravato), patients should be advised not to eat for at least 2 hours before administration and not to drink liquids at least 30 minutes prior to administration (see Nausea and vomiting under Adverse Reactions).
Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should be advised not to administer these medications within 1 hour before administration of Esketamine (Spravato).
Dosage: Adults: Treatment-resistant depression: The dosage recommendations for Esketamine (Spravato) for TRD are shown in Table 7. Dose adjustments should be made based on efficacy and tolerability to the previous dose. (See Table 7.)
Click on icon to see table/diagram/imageAfter depressive symptoms improve, treatment is recommended for at least 6 months.
Major Depressive Disorder with acute suicidal ideation or behavior: The recommended dosage for Esketamine (Spravato) for patients with MDD who have acute suicidal ideation or behavior is 84 mg twice per week for 4 weeks. Dosage reduction to 56 mg should be made based on tolerability. After 4 weeks of treatment with Esketamine (Spravato), the oral antidepressant (AD) therapy should be continued, per clinical judgement.
Patients who also have TRD should be evaluated to determine need for continued treatment with Esketamine (Spravato) beyond 4 weeks.
Post‑administration observation: During and after Esketamine (Spravato) administration at each treatment session, a healthcare professional should observe the patient until the patient is stable based on clinical judgment. Before Esketamine (Spravato) administration, instruct patients not to engage in potentially hazardous activities, such as driving a motor vehicle or operating machinery until the next day after a restful sleep. (See Effect on blood pressure, Potential for Cognitive and Motor Impairment and Effect on Driving under Precautions).
Missed treatment session(s): If a patient misses treatment session(s) during the first 4 weeks of treatment, patients should continue their current dosing schedule.
For patients with TRD who miss treatment session(s) during maintenance phase and have worsening of depression symptoms, per clinical judgement, consider returning to the previous dosing schedule (see Table 7).
Special populations: Pediatrics (17 years of age and younger): The safety and efficacy of Esketamine (Spravato) have not been established in patients aged 17 years and younger.
Elderly (65 years of age and older): In elderly patients the initial Esketamine (Spravato) dose is 28 mg (Day 1, Starting Dose, see Table 7). Subsequent doses should be increased in increments of 28 mg up to 56 mg or 84 mg, based on efficacy and tolerability.
Hepatic impairment: No dosage adjustment is necessary in patients with mild (Child‑Pugh class A) or moderate (Child‑Pugh class B) hepatic impairment.
Esketamine (Spravato) has not been studied in patients with severe hepatic impairment (Child‑Pugh class C). Use in this population is not recommended. (See Pharmacology: Pharmacokinetics: Special populations: Hepatic impairment under Actions).
Japanese and Chinese patients with treatment-resistant depression: Efficacy of Esketamine (Spravato) in Japanese and Chinese patients has not been established.
