Prescribing information For Healthcare Professionals Only

SPRAVATO®

28 mg nasal spray, solution

PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S): Esketamine hydrochloride.

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): In combination with a SSRI or SNRI, 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.

DOSAGE & ADMINISTRATION: Decision to prescribe should be determined by a psychiatrist. Self‑administered under the direct supervision of a healthcare professional (HCP). Treatment session consists of nasal administration and a post‑administration observation period, in an appropriate clinical setting. Before treatment: assess blood pressure (BP). If baseline BP is elevated, risks of short‑term increases in BP and benefit of treatment should be considered. Should not be administered if an increase in BP or intracranial pressure poses a serious risk. Additional precautions: patients with clinically significant / unstable cardiovascular / respiratory conditions: only administer in a setting where resuscitation equipment and HCPs with training in cardiopulmonary resuscitation are available. Post‑administration: assess BP 40 minutes after treatment, subsequently as clinically warranted. Monitor patients BP, for sedation and dissociation, until considered clinically stable and ready to leave. Adults <65 years: Induction phase: weeks 1-4: day 1 dose of 56 mg, then 56 mg or 84 mg twice weekly. Maintenance phase: weeks 5-8: 56 mg or 84 mg once weekly. From week 9: 56 mg or 84 mg every 2 weeks or once weekly. Adults ≥65 years: Induction phase: weeks 1-4: day 1 dose of 28 mg, then 28 mg, 56 mg or 84 mg twice weekly. Maintenance phase: weeks 5-8: 28 mg, 56 mg or 84 mg once weekly. From week 9: 28 mg, 56 mg or 84 mg every 2 weeks or once weekly. All dose changes in 28 mg increments.  Evaluate evidence of therapeutic benefit at the end of induction phase and in maintenance phase, to determine need for continued treatment. After depressive symptoms improve, treatment is recommended for at least 6 months. Children: no data. Hepatic impairment: no dose adjustment for mild (Child Pugh class A) or moderate (Child Pugh class B) hepatic impairment. Caution when using maximum dose of 84 mg with moderate hepatic impairment. Not recommended in severe hepatic impairment (Child Pugh class C). Renal impairment: no dose adjustment in mild to severe renal impairment. Patients on dialysis not studied.     

CONTRAINDICATIONS: Hypersensitivity to active substance, ketamine, or excipients. Patients for whom an increase in BP or intracranial pressure poses a serious risk: aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6 weeks) cardiovascular event, including myocardial infarction.

SPECIAL WARNINGS & PRECAUTIONS: Neuropsychiatric and motor impairments: somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo, anxiety occurred during clinical trials. At each treatment session monitor patients until considered stable as attention, judgment, thinking, reaction speed and motor skills may be impaired. Respiratory depression: concomitant use with CNS depressants may increase risk for sedation. Closely monitor for sedation and respiratory depression. Effect on BP: transient increases in systolic and/or diastolic BP with peak at approx. 40 minutes post administration, lasts approx. 1‑2 hours. Monitor BP. If BP remains elevated seek assistance from practitioners experienced in BP management; symptoms of a hypertensive crisis, refer immediately for emergency care. Cardiovascular or respiratory conditions: clinically significant or unstable cardiovascular / respiratory conditions: only initiate treatment if benefit outweighs the risk.

Suicide/suicidal thoughts or clinical worsening: monitor patients closely as risk persists until significant remission occurs, risk of suicide may increase in the early stages of recovery. Carefully monitor patients with history of suicide‑related events or who exhibit significant degree of suicidal ideation prior to treatment, they are known to be at greater risk of suicidal thoughts/suicide attempts. Provide closely supervision in early treatment and following dose changes. Alert patients and caregivers of the need to monitor for any clinical worsening, suicidal behaviour/thoughts and unusual changes in behaviour. Seek medical advice immediately if symptoms present. Drug abuse, dependence, withdrawal: Spravato contains esketamine and may be subject to abuse and diversion. Patients with history of drug abuse or dependence may be at greater risk. Prior to prescribing, assess patient’s risk for abuse or misuse. While on therapy, monitor for the development of abuse or misuse, including drug seeking behaviour. Other populations at risk: use with caution in patients with presence/history of psychosis, mania or bipolar disorder; hyperthyroidism that has not been sufficiently treated; history of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure. Hepatotoxicity reported with chronic ketamine use, cannot exclude the potential for such an effect due to long-term. Urinary tract symptoms: monitor for urinary tract and bladder symptoms during treatment. Refer to appropriate healthcare provider when symptoms persist.

SIDE EFFECTS: Very common: dizziness, nausea, dissociation, headache, somnolence, vertigo, dysgeusia, hypoaesthesia, vomiting. Common: euphoric mood, agitation, anxiety, illusion, irritability, panic attack, time perception altered, hallucination including visual hallucination, derealisation, mental impairment, tremor, lethargy, dysarthria, paraesthesia, sedation, vision blurred, hyperacusis, tinnitus, tachycardia, hypertension, nasal discomfort, nasal dryness including nasal crusting, nasal pruritus, dry mouth, hypoaesthesia oral, hyperhidrosis, pollakiuria, dysuria, micturition urgency, feeling abnormal, feeling drunk, feeling of body temperature change, BP increased. Refer to SmPC for other side effects.

PREGNANCY: Not recommended. Discontinue treatment if a woman becomes pregnant and counsel about the potential risk to the foetus and clinical/therapeutic options as soon as possible.

LACTATION: Discontinue breast-feeding or discontinue / abstain from treatment.

INTERACTIONS: Closely monitor for increase in sedation in concomitant use with CNS depressants (benzodiazepines, opioids, alcohol). Closely monitor BP when concomitantly used with psychostimulants (amphetamines, methylphenidate, modafanil, armodafinil), xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs, such as, tranylcypromine, selegiline, phenelzine. Refer to SmPC for full details of interactions.

LEGAL CATEGORY: Prescription Only Medicine (POM), CD Schedule 2.

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
28 mg nasal spray 1 device  EU/1/19/1410/001 £163
28 mg nasal spray 2 devices EU/1/19/1410/002 £326
28 mg nasal spray 3 devices EU/1/19/1410/003 £489

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK.

Prescribing information last revised: December 2019

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