Spravato

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 The nasal spray device delivers a total of 28 mg, in 2 sprays (1 spray per nostril). Do not prime before use. Prior to dosing, assess 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, w/ a 5-min rest between use of each device. Treatment-resistant major depressive disorder 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 re-examine the need for continued treatment. After depressive symptoms improve, treatment is recommended for at least 6 mth. 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. 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. Risk of 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. Patients should not eat for at least 2 hr before administration & not drink liqd at least 30 min prior to administration. Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should not administer these medicinal products w/in 1 hr before Spravato administration. A replacement device should not be used if sneezing occurs immediately after administration or if 2 consecutive sprays are administered in the same nostril. 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