Spravato

Esketamine

In combination w/ a SSRI or SNRI for adults w/ treatment-resistant major depressive disorder, who have not responded to at least 2 different treatments w/ antidepressants in the current moderate to severe depressive episode. Co-administered w/ oral antidepressant therapy in adults w/ a moderate to severe episode of major depressive disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

Nasal Do not prime before use. Prior to dosing, asses BP. After dosing, reassess BP at approx 40 min & subsequently as clinically warranted. Intended to be self-administered by the patient under direct supervision of a healthcare professional. Treatment-resistant major depressive disorder 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. All dose changes should be in 28-mg increments. Evaluate evidence of therapeutic benefit at the end of induction phase to determine need for continued treatment. Periodically reexamine the need for continued treatment. After depressive symptoms improve, treatment is recommended for at least 6 mth. Acute short-term treatment of psychiatric emergency due to major depressive disorder Adult <65 yr 84 mg twice per wk for 4 wk, reduce to 56 mg based on tolerability. Continue oral antidepressant therapy after 4 wk of treatment per clinical judgement.

Hypersensitivity to esketamine or ketamine. Patients for whom an increase in BP or ICP poses a serious risk: Patients w/ aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels); history of intracerebral haemorrhage; recent (w/in 6 wk) CV event, including MI.

Closely monitor patients for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour. Reports of somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo & anxiety. Close monitoring is required for sedation & resp depression. Can cause transient increases in systolic &/or diastolic BP. Only initiate treatment in patients w/ clinically significant or unstable CV or resp conditions if benefit outweighs risk. Individuals w/ history of drug abuse or dependence may be at greater risk for abuse & misuse of Spravato. Caution in patients w/ presence or history of psychosis; presence or history of mania or bipolar disorder; hyperthyroidism that has not been sufficiently treated; history of brain injury, hypertensive encephalopathy, intrathecal therapy w/ ventricular shunts, or any other condition associated w/ increased ICP. Monitor for urinary tract & bladder symptoms during treatment. Advise patients not to eat for at least 2 hr before administration & not to drink liqd at least 30 min prior to administration. Advise patients who require a nasal corticosteroid or nasal decongestant on a dosing day not to administer these medicinal products w/in 1 hr before Spravato administration. Major influence on the ability to drive & use machines. Max dose of 84 mg should be used w/ caution in patients w/ moderate hepatic impairment (Child-Pugh class B). Not recommended in patients w/ severe hepatic impairment (Child-Pugh class C). Potential for hepatotoxicity during long-term use. Patients on dialysis were not studied. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding or discontinue/abstain from Spravato therapy. Safety & efficacy have not been established in paed patients ≤17 yr. Has not been studied in the elderly as acute short-term treatment of psychiatric emergency due to major depressive disorder. Japanese & Chinese patients.

Dizziness, dissociation, nausea, headache, somnolence, dysgeusia, vertigo, hypoaesthesia, vomiting, increased BP.

Increased sedation w/ CNS depressants (eg, benzodiazepines, opioids, alcohol). Additional effect on BP w/ psychostimulants (eg, amphetamines, methylphenidate, modafinil, armodafinil) or other medicinal products that may increase BP (eg, xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs eg, tranylcypromine, selegiline, phenelzine).

Antidepressants

N06AX27 - esketamine ; Belongs to the class of other antidepressants.

DD, P₁S₁S₃