Brintellix®▼ (vortioxetine) film–coated tablets
Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10 or 20mg of vortioxetine (as the hydrobromide). Indications: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. Dose may be increased to a maximum of 20mg daily or reduced to 5mg if necessary. After depressive symptoms resolve, treatment for at least 6 months is recommended. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily as data are limited. Children and adolescents (<18 years): Not recommended as safety and efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal impairment: Exercise caution in severe impairment as data are limited in these patients. Hepatic impairment: Exercise caution in severe hepatic impairment as no data in these patients. Contraindications: Hypersensitivity to the active substance or any of the excipients. Concomitant use with non–selective, monoamine oxidase inhibitors (MAOIs) or selective MAO–A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Do not use in pregnancy unless clinically necessary. Limited data on the use of vortioxetine in pregnant women. Animal studies have shown reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). It is expected that vortioxetine will be excreted into human milk, and a risk to the suckling child cannot be excluded. Fertility: Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far. Precautions: Use caution when driving a car or operating machinery. Closely supervise patients, especially those at high risk, for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome, and discontinue if occurs. Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9. Potential for interactions with: MAOIs, MAO–A and MAO–B inhibitors; serotonergic medicines (e.g. triptans or tramadol); St John’s wort; products which may lower the seizure threshold, e.g. antidepressants (tricyclic, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine or bupropion. Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment. Additionally these effects may be greater in patients who are poor metabolisers of CYP2D6. A dose adjustment may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment. Adverse events: Adverse reactions were usually mild or moderate, transient and occurred within the first two weeks of treatment. The following adverse events were reported: Very common (>1/10 patients); nausea. Common (>1/100 <1/10); abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritis, including generalised pruritis. Uncommon (>1,000 <1/100); flushing, night sweats. Unknown: Serotonin syndrome. Sexual dysfunction: The 20mg dose of vortioxetine was associated with an increase in treatment–emergent sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Prescribers should consult the full SPC in relation to other side effects. Overdose: Limited experience. Management consisting of treating clinical symptoms and relevant monitoring.
Legal category: POM. Brintellix® Tablets, blisters of:
5mg (EU/1/13/891/002) 28 tablets, £27.72;
10mg (EU/1/13/891/010) 28 tablets, £27.72;
20mg (EU/1/13/891/028) 28 tablets, £27.72.
Further information available from:
Lundbeck Limited, Building K1, Timbold Drive, Kents Hill, Milton Keynes,
Tel: 01908 638972.
® Brintellix® is a Registered Trade Mark.
Date of last revision of PI: June 2015.