Active Ingredient: Esketamine
Esketamine, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
For this indication, competent medicine agencies globally authorize below treatments:
Nasal
28 - 84 mg
From 28 To 84 mg once every 7 day(s)
Prior to dosing with esketamine blood pressure should be assessed.
If baseline blood pressure is elevated the risks of short-term increases in blood pressure and benefit of esketamine treatment should be considered. Esketamine should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk.
Patients with clinically significant or unstable cardiovascular or respiratory conditions require additional precautions. In these patients, esketamine should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available.
After dosing with esketamine, blood pressure should be reassessed at approximately 40 minutes and subsequently as clinically warranted.
Because of the possibility of sedation, dissociation and elevated blood pressure, patients must be monitored by a healthcare professional until the patient is considered clinically stable and ready to leave the healthcare setting.
The dose recommendations for esketamine are shown in the table below. It is recommended to maintain the dose the patient receives at the end of the induction phase in the maintenance phase. Dose adjustments should be made based on efficacy and tolerability to the previous dose. During the maintenance phase, esketamine dosing should be individualised to the lowest frequency to maintain remission/response.
Recommended dosing for esketamine in adults ≥65 years:
| Induction phase | Maintenance phase |
|---|---|
| Weeks 1-4: Starting day 1 dose: 28 mg Subsequent doses: 28 mg, 56 mg or 84 mg twice a week, all dose changes should be in 28 mg increments | Weeks 5-8: 28 mg, 56 mg or 84 mg once weekly, all dose changes should be in 28 mg increments From week 9: 28 mg, 56 mg or 84 mg every 2 weeks or once weekly, 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 months.
Since some patients may experience nausea and vomiting after administration of esketamine, 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.
Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should be advised not to administer these medicinal products within 1 hour before esketamine administration.
In case one or two treatment sessions are missed, the next session should be scheduled when the next session was scheduled to occur based on current treatment frequency. If more than 2 treatment sessions have been missed, per clinical judgment, adjustment of the dose or frequency of esketamine may be clinically appropriate.
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