Major depressive disorder

Active Ingredient: Esketamine

Indication for Esketamine

Population group: only elderly (65 years old or older)

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:

28-84 mg once every 1-2 weeks

Route of admnistration

Nasal

Defined daily dose

28 - 84 mg

Dosage regimen

From 28 To 84 mg once every 7 day(s)

Detailed description

Assessment before treatment

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.

Post-administration observation

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.

Posology

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.

Food and liquid intake recommendations prior to administration

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.

Nasal corticosteroid or nasal decongestant

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.

Missed treatment session(s)

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.

Active ingredient

Esketamine

Esketamine, the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. Through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release. Restoration of dopaminergic neurotransmission in brain regions involved in the reward and motivation, and decreased stimulation of brain regions involved in anhedonia, may contribute to the rapid response.

Read more about Esketamine

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