vortioxetine hydrobromide: clinical use

Prescribing considerations

• Licensed for adult major depressive episodes; efficacy has not been demonstrated for paediatric major depressive disorder.
• Review suicide risk and clinical worsening, especially early in treatment and after treatment changes.
• Use caution with seizure disorders, previous mania or hypomania, bleeding tendency, glaucoma risk, hyponatraemia risk, older age, and significant renal or hepatic disease.
• Review serotonergic medicines and CYP2D6 inhibitors or broad enzyme inducers before prescribing.
• Discontinuation symptoms have been reported after stopping; plan cessation individually.

Contraindications and cautions

• Hypersensitivity to vortioxetine or an excipient.
• Concomitant use with non-selective MAOIs or selective MAO-A inhibitors.

Monitoring

• Mood, suicidal ideation and unusual behavioural change.
• Serotonin syndrome, mania, agitation or aggression.
• New seizures or increased seizure frequency.
• Bleeding, particularly with medicines affecting haemostasis.
• Clinical features of hyponatraemia in susceptible patients.
• Eye pain or visual change in patients at risk of angle-closure glaucoma.

Clinical pharmacology

Vortioxetine inhibits the serotonin transporter and modulates several serotonin receptors. It is extensively hepatically metabolised, principally through CYP2D6; its major metabolite is inactive. It has a long elimination half-life and high plasma-protein binding.

Formulation and product differences

• The selected products are oral film-coated tablets whose colour and imprint vary by strength.
• The selected product record states that the listed 15 mg tablet is not marketed.
• The tablets are essentially sodium-free.

Tablet

Route: Oral

Strengths: 5 mg, 10 mg, 20 mg