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Resources
These materials were created to help inform you and your patients about MDD and Trintellix.
Safety Information
Safety Information
Indication and clinical use:
PrTrintellix® (vortioxetine) is indicated for the treatment of major depressive disorder (MDD) in adults.
The efficacy in providing symptomatic relief of MDD was demonstrated in double-blind, placebo-controlled trials of up to 8 weeks in duration. The efficacy in maintaining an antidepressant response for up to 24 weeks was demonstrated in a double-blind, placebo-controlled trial in patients with MDD who initially responded to 12-week acute, open-label treatment. Physicians who elect to use Trintellix for extended periods should periodically re-evaluate the usefulness of the drug for individual patients.
The lowest effective dose of 5 mg/day should always be used as the starting dose in elderly patients ≥65 years of age.
Not indicated in patients <18 years of age.
Contraindication:
- Combined use with monoamine oxidase inhibitors (MAOIs)
Most serious warnings and precautions:
- Potential association with behavioural and emotional changes, including self-harm:
Severe agitation-type events reported; rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages; this includes monitoring for agitation-type emotional and behavioural changes. - Discontinuation symptoms: Gradual reduction in dose, rather than abrupt cessation, is recommended.
Other relevant warnings and precautions:
- Dependence/tolerance
- Caution when driving or operating machinery
- Abnormal bleeding
- Potential for increased risk of postpartum hemorrhage
- Caution in moderate or severe hepatic impairment
- Bone fracture risk
- Caution in patients who have a history of seizures or in patients with unstable epilepsy
- Serotonin syndrome/neuroleptic malignant syndrome
- Cognitive and motor disturbances
- Angle-closure glaucoma
- Caution in patients with a history of mania/hypomania and discontinue use in any patient entering a manic phase
- Aggression/agitation
- Caution with concurrent use of electroconvulsive therapy (ECT)
- Hyponatremia
- Caution in patients with severe renal insufficiency
- Not recommended during breastfeeding
- Dosage adjustment in elderly patients
For more information:
Consult the Trintellix Product Monograph for important information relating to adverse reactions, drug interactions and dosing information not discussed in this piece.
The product monograph is also available by calling 1-800-586-2325.
Reference: Trintellix Product Monograph. Lundbeck Canada Inc. August 4, 2021.