Safety Information

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Safety Information

Indication and clinical use:

TRINTELLIX (vortioxetine) is indicated for the treatment of MDD (Major Depressive Disorder) in adults.

Efficacy in providing symptomatic relief of MDD demonstrated in trials of up to 8 weeks’ duration; efficacy in maintaining an antidepressant response demonstrated for up to 24 weeks. 

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 pediatric patients.

Contraindication:

  • Combined use with monoamine oxidase inhibitors (MAOIs)

Most serious warnings and precautions:

  • Increased risk of self-harm, harm to others, suicidal thinking and behaviour: Closely monitor for clinical worsening and for emergence of agitation type and/or suicidal thoughts and behaviours. 

Other relevant warnings and precautions:

  • Potential for abuse
  • Discontinuation symptoms
  • 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 toxicity/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 
  • Long-lasting sexual dysfunction
  • Not recommended during breastfeeding 
  • Dosage adjustment in elderly patients

For more information:

Consult the TRINTELLIX Product Monograph for important information about contraindications, warnings, precautions, adverse reactions, interactions, dosing instructions and conditions of clinical use not discussed in this piece.

The Product Monograph is also available by calling 1-800-586-2325.

Reference: TRINTELLIX Product Monograph. Lundbeck Canada Inc., May 27, 2024.

Resources

These materials were created to help inform you and your patients about MDD and TRINTELLIX.

Three Trintellix patients

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Trintellix Dose Card PDF Thumbnail

Dose Card

Download this tool to help with dosing with TRINTELLIX.

Trintellix Efficacy and Tolerability Profile PDF thumbnail

TRINTELLIX Efficacy and Tolerability Profile

This document presents information about TRINTELLIX efficacy and tolerability profile.

Trintellix Patient Profile PDF thumbnail

Meet Michelle

Learn about Michelle, a patient who was weighing her MDD treatment options.

Trintellix Patient Profile PDF thumbnail

Meet Max

Max was exploring his MDD treatment options. Do you have patients like Max in your practice?

Trintellix Patient Profile PDF thumbnail

Meet Sarah

Sarah has depression-related anxiety symptoms and was considering her treatment options.

Montgomery-Åsberg Depression Rating Scale (MADRS)

This scale measures the severity of depression in adults.1

Hamilton Anxiety Rating Scale (HAM-A)

This scale measures the severity of psychic and somatic anxiety symptoms.

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 objectifies and assesses degree of depression severity via questionnaire.

The Patient Website contains information about TRINTELLIX, MDD facts and tips & resources. Your patients can access it via the QR code on the TRINTELLIX package.

Trintellix 5mg outer package with spotlight on QR code and DIN
Trintellix Patient Brochure PDF thumbnail

Patient Brochure

Important information about taking TRINTELLIX, MDD facts and a helpful symptom tracking tool are included.

Trintellix Symptom Tracker PDF thumbnail

Symptom Tracker

Designed to help patients record how they’re feeling while taking TRINTELLIX. Patients are encouraged to bring the tracker to their doctor’s appointment to discuss their progress.

Trintellix Doctor Discussion Guide PDF thumbnail

Doctor Discussion Guide

Offers patients a number of questions about TRINTELLIX to facilitate discussion with their physicians.

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* Not available in Quebec
Reference: 1.
American Psychological Association. Depression assessment instruments. Available at: https://www.apa.org/depression-guideline/assessment/. Accessed on April 1, 2024.

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