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Posology In general, recommended initial dose in adults is 100 mg lasmiditan for acute treatment of migraine attacks. If necessary, the dose can be increased to 200 mg for greater efficacy or can be decreased to 50 mg for greater tolerability.

If the migraine headache recurs within 24 hours of an initial response after taking 50 mg or 100 mg lasmiditan, a second dose of the same strength may be taken. The second dose should not be taken within 2 hours of the initial dose.

No more than 200 mg should be taken in 24 hours. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack. Lasmiditan may be taken with or without food. 2). 2). Hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment.

2). Paediatric population The safety and efficacy of lasmiditan in children and adolescents aged 6 to <18 years have not yet been established. No data are available. There is no relevant use of lasmiditan in children below the age of 6 years for the treatment of migraine.

Method of administration Oral use.

3 %). Most of the adverse events showed a dose response. Tabulated list of adverse reactions In the following table, adverse reactions are listed in order of MedDRA body system organ class and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Frequency gradings are: 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). Table 1. Adverse reactions System organ class Very common Common Uncommon Rare Immune system disorders Hypersensitivity Psychiatric disorders Sleep abnormalities Confusion Hallucinations Euphoric mood Anxiety Restlessness Nervous system disorders Dizziness Incoordination Paraesthesia Hypoaesthesia Somnolence Lethargy Disturbance in attention Cognitive disorder Mental impairment Tremor Speech abnormalities Serotonin syndrome Eye disorders Visual impairment Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Vomiting Nausea 7 Musculoskeletal and connective tissue disorders Muscular weakness Muscle spasm Limb discomfort General disorders and administration site conditions Feeling abnormal Fatigue Malaise Chest discomfort Feeling hot or feeling cold Description of selected adverse reactions Heart rate decrease In clinical pharmacology studies, lasmiditan was associated with decreases in heart rate of 5 to 10 bpm compared to a decrease of 2-5 bpm for placebo.

Incidence of bradycardia (< 50 bpm and a decrease from baseline ≥ 15 bpm) observed in lasmiditan-treated subjects was 7 % for 50 mg, 3 % for 100 mg, 4 % for 200 mg, and 1 % for placebo. Blood pressure increase Single dose administration of lasmiditan may lead to a transient increase in blood pressure.

In non-elderly healthy volunteers a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg lasmiditan was observed, compared to an increase of about 1 mm Hg for placebo.

Central nervous system (CNS) effects and driving impairment Lasmiditan is associated with CNS adverse reactions. 7). Patients should be advised not to drive or engage in other activities requiring heightened attention until at least 8 hours after taking each dose of lasmiditan, even if they feel well enough to do so.

Patients who cannot follow this advice should not take lasmiditan. , selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors].

Clinical experience for the use of lasmiditan and triptans in temporal proximity is limited. The risks of developing serotonin syndrome may be additive. g. g. g. g. nausea, vomiting, diarrhoea). These reactions can be severe. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medicinal product.

If concomitant treatment with other serotonergic medicinal products is clinically warranted, appropriate observation of the patient is advised, particularly during treatment initiation, and with dose increases. Lasmiditan should be discontinued if serotonin syndrome is suspected.

CNS depressants Because of the potential of lasmiditan to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, lasmiditan should be used with caution if used in combination with alcohol or other CNS depressants.

Medicinal products misuse or abuse potential In a human abuse potential study with recreational drug users, single lasmiditan doses of 100 or 200 mg were associated with greater drug-liking than placebo. In a separate study, there was no evidence of physical withdrawal in healthy subjects following abrupt cessation after 7 days of dosing.

Patients should be evaluated for risk of drug abuse and observed for signs of lasmiditan misuse or abuse. Medication overuse headache (MOH) Overuse of any type of medicinal products for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued.

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