The single-use device delivers a total of 28 mg of esketamine in 2 sprays (1 spray per nostril). Intended for administration by the patient under the supervision of a healthcare professional, using 1 device (28-mg dose), 2 devices (56-mg dose) or 3 devices (84-mg dose), w/ a 5-min rest between use of each device. Prior to dosing, BP should be assessed. After dosing, BP should be reassessed at approx 40 min & subsequently as clinically warranted. Adult <65 yr Induction phase
Wk 1-4: Starting day 1 dose: 56 mg. Subsequent doses: 56 mg or 84 mg twice a wk. Maintenance phase
Wk 5-8: 56 mg or 84 mg once wkly. From wk 9: 56 mg or 84 mg every 2 wk or once wkly. Elderly ≥65 yr Induction phase
Wk 1-4: Starting day 1 dose: 28 mg. Subsequent doses: 28 mg, 56 mg or 84 mg twice a wk. Maintenance phase
Wk 5-8: 28 mg, 56 mg or 84 mg once wkly. From wk 9: 28 mg, 56 mg or 84 mg every 2 wk or once wkly. Patient of Japanese ancestry
Initially 28 mg (day 1, starting dose). Subsequent doses should be increased in increments of 28 mg up to 56 or 84 mg, based on efficacy & tolerability. All dose changes should be in 28 mg increments. Evidence of therapeutic benefit should be evaluated at the end of induction phase to determine need for continued treatment. The need for continued treatment should be reexamined periodically. After depressive symptoms improve, treatment is recommended for at least 6 mth.