HIGHLIGHT
Spravato速開朗

Spravato

esketamine

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Esketamine
Indications/Uses
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.
Dosage/Direction for Use
Nasal The single-use device delivers a total of 28 mg of esketamine in 2 sprays (1 spray per nostril). Intended for administration by the patient under the supervision of a healthcare professional, using 1 device (28-mg dose), 2 devices (56-mg dose) or 3 devices (84-mg dose), w/ a 5-min rest between use of each device. Prior to dosing, BP should be assessed. After dosing, BP should be reassessed at approx 40 min & subsequently as clinically warranted. 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. Patient of Japanese ancestry Initially 28 mg (day 1, starting dose). Subsequent doses should be increased in increments of 28 mg up to 56 or 84 mg, based on efficacy & tolerability. 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 mth.
Contraindications
Hypersensitivity. Patients for whom an increase in BP or intracranial pressure 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.
Special Precautions
Somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo & anxiety; may impair attention, judgment, thinking, reaction speed & motor skills. Concomitant use w/ CNS depressants may increase the risk for sedation. Close monitoring is required for sedation & resp depression. Can cause transient increases in systolic &/or diastolic BP. Patients w/ clinically significant or unstable CV or resp conditions require additional precautions. 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 intracranial pressure. Monitor for urinary tract & bladder symptoms during treatment. Closely monitor patients for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour. Individuals w/ history of drug abuse or dependence may be at greater risk for abuse & misuse of Spravato. Major influence on the ability to drive & use machines. Max dose (84 mg) should be used w/ caution in patients w/ moderate hepatic impairment. Not recommended in patients w/ Child-Pugh class C (severe) hepatic impairment. Potential for hepatotoxicity during long-term use cannot be excluded. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn ≤17 yr. Elderly.
Adverse Reactions
Dizziness, nausea, dissociation, headache, somnolence, vertigo, dysgeusia, hypoaesthesia, vomiting.
Drug Interactions
Increased sedation w/ CNS depressants (eg, benzodiazepines, opioids, alcohol). Additional effect on BP w/ psychostimulants (eg, amphetamines, methylphenidate, modafanil, armodafinil) or other medicinal products that may increase BP (eg, xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs eg, tranylcypromine, selegiline, phenelzine). Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should be advised not to administer these medicinal products w/in 1 hr before Spravato administration.
MIMS Class
ATC Classification
N06AX27 - esketamine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Spravato nasal spray 28 mg/device
Packing/Price
2's;3's
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