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Brintellix is a brand name for Vortioxetine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Brintellix is indicated for the treatment of major depressive episodes in adults.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. 8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Brintellix.
Special populations Elderly patients The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. 4). g. 5). 5). 1). 1. 2). Method of administration Brintellix is for oral use.
The film-coated tablets can be taken with or without food. 4
Summary of the safety profile The most common adverse reaction was nausea. Tabulated list of adverse reactions Adverse reactions are listed below 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).
The list is based on information from clinical trials and post-marketing experience. 4) Vascular disorders Uncommon Flushing Not known* Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding) Gastrointestinal disorders Very common Nausea Common Diarrhoea, Constipation, Vomiting, Dyspepsia Skin and subcutaneous tissue disorders Common Pruritus, including pruritus generalised Hyperhidrosis Uncommon Night sweats Not known* Angioedema, Urticaria Rash General disorder and administration site conditions Not known* Discontinuation syndrome * Based on post-marketing cases Description of selected adverse reactions Nausea Nausea was usually mild or moderate and occurred within the first two weeks of treatment.
The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men. Elderly patients For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
4). Sexual dysfunction In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. 1). In the post-marketing setting cases of sexual dysfunction have also been reported with doses of vortioxetine below 20 mg.
Class effect Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs).
1). 1). In clinical studies in children and adolescents treated with antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
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.
A meta-analysis of placebo-controlled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
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.
Seizures Seizures are a potential risk with antidepressants. 5). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine. Paediatric population A total of 304 children aged 7 to 11 years and 308 adolescents aged 12 to 17 years with major depressive disorder (MDD) were treated with vortioxetine in two double-blind, placebo-controlled studies, respectively.
1). Two long-term open-label extension studies were performed with vortioxetine doses of 5 to 20 mg/day, and with a treatment duration of 6 months (N=662) and 18 months (N=94), respectively. Overall, the safety and tolerability profile of vortioxetine in the paediatric population after long-term use was comparable to what has been observed after short-term use.
Symptoms upon discontinuation of vortioxetine treatment In the clinical studies, discontinuation symptoms were systematically evaluated following abrupt cessation of vortioxetine treatment. 1). Cases describing discontinuation symptoms have been reported in the post-marketing setting and have included symptoms such as dizziness, headache, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia), nausea and/or vomiting, anxiety, irritability, agitation, fatigue and tremor.
These symptoms may occur within the first week of vortioxetine discontinuation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including opioids and triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
5). , nausea, vomiting, diarrhoea). If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated. Mania/hypomania Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Aggression/agitation Patients treated with antidepressants, including vortioxetine, may also experience feelings of aggression, anger, agitation and irritability. Patient’s condition and disease status should be closely monitored. Patients (and caregivers of patients) should be alerted to seek medical advice, if aggressive/agitated behaviour emerges or aggravates.
Haemorrhage Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine.
6). 5) and in patients with known bleeding tendencies/disorders. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medicinal products known to cause hyponatraemia. Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Glaucoma Mydriasis has been reported in association with use of antidepressants, including vortioxetine. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma.
Caution is advised when prescribing vortioxetine to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma. Elderly Data on the use of Brintellix in elderly patients with major depressive episodes are limited.
2). Renal or hepatic impairment […]