Spravato · 4.3 Contraindications · 1

HOS-098407 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile The most commonly observed adverse reactions in patients treated with Spravato were dizziness (31%), dissociation (27%), nausea (27%), headache (23%), somnolence (18%), dysgeusia (18%), vertigo (16%), hypoaesthesia (11%), vomiting (11%), and blood pressure increased (10%). Tabulated list of adverse reactions Adverse reactions reported with esketamine are listed in Table 3. Within the designated system organ classes, adverse reactions are listed under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data). Table 3: List of adverse reactions System Organ Class Adverse Drug Reaction Frequency Very common Common Uncommon Rare Psychiatric disorders dissociation anxiety, euphoric psychomotor mood, confusional retardation, state, emotional derealisation, distress, irritability, dysphoria hallucination including visual hallucination, agitation, illusion, panic attack, time perception altered 8 Nervous system disorders dizziness, paraesthesia, nystagmus, seizure headache, sedation, tremor, psychomotor somnolence, mental hyperactivity dysgeusia, impairment, hypoaesthesia lethargy, dysarthria,

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HOS-098403 · has-contraindication-information · PDF-Seite 5

 Hypersensitivity to the active substance, ketamine, or to any of the excipients listed in section 6.1.  Patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.8): - Patients with aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels). - Patients with history of intracerebral haemorrhage. - Recent (within 6 weeks) cardiovascular event, including myocardial infarction (MI).

HOS-098402 · has-indication-information · PDF-Seite 2

Spravato, in combination with a SSRI or SNRI, is indicated 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. Spravato, co-administered with oral antidepressant therapy, is indicated in adults with 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. See section 5.1 for a description of the populations studied.

HOS-098405 · has-interaction-information · PDF-Seite 7

Concomitant use of Spravato with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation, which therefore should be closely monitored. Blood pressure should be closely monitored when Spravato is used concomitantly with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) or other medicinal products that may increase blood pressure (e.g., xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs, such as, tranylcypromine, selegiline, phenelzine).

HOS-098406 · has-pregnancy-information · PDF-Seite 7

Women of childbearing potential Spravato is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnancy There are no or limited data on the use of esketamine in pregnant women. Animal studies have shown that ketamine, the racemic mixture of arketamine and esketamine, induces neurotoxicity in developing foetuses (see section 5.3). A similar risk with esketamine cannot be excluded. 7 If a woman becomes pregnant while being treated with Spravato, treatment should be discontinued, and the patient should be counselled about the potential risk to the foetus and clinical/therapeutic options as soon as possible. Breast-feeding It is unknown whether esketamine is excreted in human milk. Data in animals have shown excretion of esketamine in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Spravato therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Fertility Animal studies showed that fertility and reproductive capacities were not adversely affected by esketamine.

HOS-098404 · has-warning-information · PDF-Seite 5

Suicide/suicidal thoughts or clinical worsening The effectiveness of esketamine in preventing suicide or in reducing suicidal ideation or behaviour has not been demonstrated (see section 5.1). Use of esketamine does not preclude the need for hospitalisation if clinically warranted, even if patients experience improvement after an initial dose of esketamine. Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs, therefore, patients should be closely monitored. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. Neuropsychiatric and motor impairments Esketamine has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety during the clinical trials (see section 4.8). These effects may impair attention, judgment, thinking, reaction speed and motor skills. At each treatment session, patients should be monitored under the supervision of a healthcare professional to assess when the patient is considered stable based on clinical judgement (see section 4.7). Respiratory depression Respiratory depression may occur at high doses following rapid intravenous injection of esketamine or ketamine when used for anaesthesia. Rare cases of deep sedation have been reported. Concomitant use of esketamine with CNS depressants may increase the risk for sedation (see section 4.5). During post- marketing use, rare cases of respiratory depression have been observed. The majority of these cases have been reported with concomitant use of CNS depressants and/or in patients with comorbidities such as obesity, anxiety, cardiovascular and respiratory conditions. These events were transient in n

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