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:
For:
Regimen A :
Nasal, 56 milligrams esketamine, one dose. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, 2 times weekly, over the duration of 4 weeks. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, once weekly, over the duration of 4 weeks. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, once weekly.
Regimen B :
Nasal, 56 milligrams esketamine, one dose. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, 2 times weekly, over the duration of 4 weeks. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, once weekly, over the duration of 4 weeks. Afterwards, nasal, between 56 milligrams esketamine and 84 milligrams esketamine, once every 2 weeks.
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: 56 mg Subsequent doses: 56 mg or 84 mg twice a week | Weeks 5-8: 56 mg or 84 mg once weekly From Week 9: 56 mg or 84 mg every 2 weeks or once weekly |
| 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 re-examined 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.
Patients who have missed treatment session(s) during the first 4 weeks of treatment should continue with their current dosing schedule.
For patients with treatment-resistant Major Depressive Disorder who miss treatment session(s) during maintenance phase and have worsening of depression symptoms, per clinical judgement, consider returning to the previous dosing schedule.
If sneezing occurs immediately after administration, a replacement device should not be used.
If administration in the same nostril occurs, a replacement device should not be used.
Treatment discontinuation does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
For:
Regimen A :
Nasal, 28 milligrams esketamine, one dose. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, 2 times weekly, over the duration of 4 weeks. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, once weekly, over the duration of 4 weeks. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, once every 2 weeks.
Regimen B :
Nasal, 28 milligrams esketamine, one dose. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, 2 times weekly, over the duration of 4 weeks. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, once weekly, over the duration of 4 weeks. Afterwards, nasal, between 28 milligrams esketamine and 84 milligrams esketamine, once weekly.
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 with treatment-resistant Major Depressive Disorder:
| 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 re-examined 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.
Patients who have missed treatment session(s) during the first 4 weeks of treatment should continue with their current dosing schedule.
For patients with treatment-resistant Major Depressive Disorder who miss treatment session(s) during maintenance phase and have worsening of depression symptoms, per clinical judgement, consider returning to the previous dosing schedule.
If sneezing occurs immediately after administration, a replacement device should not be used.
If administration in the same nostril occurs, a replacement device should not be used.
Treatment discontinuation does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.