BRINTELLIX

What it is

Brintellix is vortioxetine hydrobromide, a film-coated tablet. Each tablet contains 6.355, 12.71, 19.065, or 25.42 mg of vortioxetine hydrobromide equivalent to 5, 10, 15, or 20 mg of vortioxetine, respectively.

Approved indications —

Treatment of major depressive disorder in adults including prevention of relapse.

Dosing overview

The starting and recommended dose of Brintellix in adults less than 65 years of age is 10 mg once daily, taken with or without food. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily or reduced to a minimum of 5 mg daily. The recommended starting dose is 5 mg vortioxetine once daily and should always be used as the starting dose in patients ≥ 65 years of age. Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily. An antidepressant effect of Brintellix based on the primary efficacy measure was generally observed starting at week 2.

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. This risk must be considered in all depressed patients. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Pooled analyses of short-term studies of antidepressant medications have shown an increased risk of suicidal thinking and behaviour in young adults aged 18 to 24 years during initial treatment. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond the age of 24 years, and there was a reduction with antidepressants compared to placebo in adults aged 65 years and older. Development of serotonin syndrome or neuroleptic malignant syndrome, potentially life-threatening conditions, may occur in association with treatment with Brintellix. The risk of serotonin syndrome or neuroleptic malignant syndrome is increased with concomitant use of serotonergic active substances (including opioids and triptans), medicinal products that impair the metabolism of serotonin (including monoamine oxidase inhibitors), antipsychotics, and other dopamine antagonists. Symptoms and signs of serotonin syndrome include rapid onset of neuromuscular excitation, altered mental status and autonomic dysfunction and/or gastrointestinal symptoms. Treatment with Brintellix should be discontinued if such events occur and supportive symptomatic treatment initiated. Brintellix should be used with caution in patients with a history of mania or hypomania. It is generally believed that treating a major depressive episode with an antidepressant alone can increase the likelihood of precipitation of a mixed or manic episode in patients at risk of bipolar disorder. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression. Bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal or gynaecological haemorrhage may occur. Antidepressants with serotonergic effects, including vortioxetine, may increase the risk of postpartum haemorrhage. Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, nonsteroidal anti-inflammatory drugs or aspirin), and in patients with known bleeding tendencies.

Contraindications

Hypersensitivity to vortioxetine or any of the tablet excipients is a contraindication. Brintellix should not be used in combination with a monoamine oxidase inhibitor, or within at least 14 days of discontinuing treatment with a monoamine oxidase inhibitor. Brintellix should be discontinued for at least 14 days before starting treatment with a monoamine oxidase inhibitor.

PBS listing

No information regarding PBS listing, restriction type, or ex-manufacturer price is available in the provided source documents.

Regulatory history

Brintellix vortioxetine (as hydrobromide) tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg were first listed on the Australian Register of Therapeutic Goods on 31 March 2014.