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SPRAVATO is intended to be self-administered by the patient under the direct supervision of a healthcare professional.
A treatment session consists of nasal administration of SPRAVATO and a post-administration observation period. Both administration and post-administration observation of SPRAVATO should be carried out in an appropriate clinical setting.
Assessment before treatment: Prior to dosing with SPRAVATO blood pressure should be assessed.
If baseline blood pressure is elevated the risks of short-term increases in blood pressure and benefit of SPRAVATO treatment should be considered (see Precautions). SPRAVATO should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk (see Contraindications).
Patients with clinically significant or unstable cardiovascular or respiratory conditions require additional precautions. In these patients, SPRAVATO should be administered in a setting where appropriate resuscitation equipment and healthcare professionals with training in cardiopulmonary resuscitation are available (see Precautions).
Post-administration observation: After dosing with SPRAVATO, blood pressure should be reassessed at approximately 40 minutes and subsequently as clinically warranted (see Precautions).
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 (see Precautions).
Posology: The dose recommendations for SPRAVATO are shown in Table 7 and Table 8 (adults ≥65 years). 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, SPRAVATO dosing should be individualised to the lowest frequency to maintain remission/response. (See Tables 7 and 8.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageAfter 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 SPRAVATO, 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 (see Adverse Reactions).
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 SPRAVATO 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 SPRAVATO may be clinically appropriate.
Special populations: Elderly (65 years of age and older): In elderly patients the initial SPRAVATO dose is 28 mg esketamine (day 1, starting dose, see Table 7 previously). Subsequent doses should be increased in increments of 28 mg up to 56 mg or 84 mg, based on efficacy and tolerability.
Hepatic impairment: No dose adjustment is necessary in patients with mild (Child Pugh class A) or moderate (Child Pugh class B) hepatic impairment. However, the maximum dose of 84 mg should be used with caution in patients with moderate hepatic impairment.
SPRAVATO has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in this population is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is necessary in patients with mild to severe renal impairment. Patients on dialysis were not studied.
Japanese and Chinese patients with treatment-resistant Major depressive Disorder: Efficacy of SPRAVATO in Japanese patients has not been established to date.
Paediatric population: The safety and efficacy of SPRAVATO in paediatric patients aged 17 years and younger have not been established. No data are available. There is no relevant use of SPRAVATO in children less than 7 years of age in the indication for treatment-resistant depression.
Depressive symptoms in patients with major depressive disorder with acute suicidal ideation or behaviour: Administer SPRAVATO in conjunction with an oral antidepressant (AD).
The recommended dosage of SPRAVATO for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior is 84 mg twice per week for 4 weeks. Dosage may be reduced to 56 mg twice per week based on tolerability. After 4 weeks of treatment with SPRAVATO, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. The use of SPRAVATO, in conjunction with an oral antidepressant, beyond 4 weeks has not been systematically evaluated in the treatment of depressive symptoms in patients with MDD with acute suicidal ideation or behavior.
Method of administration: SPRAVATO is for nasal use only. The nasal spray device is a single-use device that delivers a total of 28 mg of esketamine, in two sprays (one spray per nostril). To prevent loss of medicinal product, the device should not be primed before use. It is intended for administration by the patient under the supervision of a healthcare professional, using 1 device (for a 28 mg dose), 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device.
Sneezing after administration: If sneezing occurs immediately after administration, a replacement device should not be used.
Use of the same nostril for 2 consecutive sprays: If administration in the same nostril occurs, a replacement device should not be used.
Treatment discontinuation with SPRAVATO does not require tapering off; based on data from clinical trials the risk of withdrawal symptoms is low.
