Brintellix

/ Lundbeck

The starting and recommended dose of Vortioxetine 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.
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.
Cytochrome P450 inhibitors: Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to Vortioxetine treatment.
Cytochrome P450 inducers: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to Vortioxetine treatment.
Paediatric population: The safety and efficacy of Vortioxetine in children and adolescents aged less than 18 years have not been established. No data are available.
See prescribing information for full details.

Treatment of major depressive episodes in adults.

Hypersensitivity to the active substance or to any of the excipients. Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors.

Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. 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. There is 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.
Seizures: Seizures are a potential risk with antidepressants. 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): Potentially life-threatening conditions may occur with Vortioxetine. The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists. Patients should be monitored for the emergence of signs and symptoms of SS or NMS.
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.
Hemorrhage: Bleeding abnormalities have been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function and in patients with known bleeding tendencies/disorders.
Hyponatraemia: Hyponatraemia 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 medications known to cause hyponatraemia.
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 Vortioxetine in elderly patients are limited.
Renal impairment: Limited data are available.
Hepatic impairment: Vortioxetine has not been studied in patients with severe hepatic impairment.
See prescribing information for full details.

Very common: Nausea.
Common: Dizziness, abnormal dreams, diarrhea, constipation, vomiting, dyspepsia, pruritus (including pruritus generalised Hyperhidrosis).
See prescribing information for full details.

Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6and to a minor extent CYP3A4/5and CYP2C9. Potential for other medicinal products to affect vortioxetine.
Irreversible non-selective MAOIs: Due to the risk of Serotonin Syndrome, vortioxetine is contraindicated in any combination with irreversible non-selective MAOIs. Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI. Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI.
Reversible, selective MAO-A inhibitor (moclobemide): The combination of vortioxetine with a reversible and selective MAO-A inhibitor, such as moclobemide, is contraindicated .If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for Serotonin Syndrome.
Reversible, non-selective MAOI (linezolid): The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated. If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for Serotonin Syndrome.
Serotonergic medicinal products: Co-administration of medicinal products with serotonergic effect e.g. opioids (including tramadol) and triptans (including sumatriptan) may lead to serotonin syndrome.
Medicinal products lowering the seizure threshold: Antidepressants with serotonergic effect can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e.g., antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, tramadol].
See prescribing information for full details.

Pregnancy:
There is limited data from the use of vortioxetine in pregnant women.
The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in the later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor,
jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Brintellix should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Lactation:
It is expected that vortioxetine will be excreted into human milk.A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
See prescribing information for full details.                

Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg. In the majority of cases, no symptoms or mild symptoms were reported. The most frequently reported symptoms were nausea and vomiting.
There is limited experience with vortioxetine overdoses above 80 mg. Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Medical follow-up in a specialised environment is recommended.

Storage: Store below 30ºC.