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.

Learn about the efficacy data

Tolerability Profile

TRINTELLIX has an excellent tolerability profile1

Incidence of common adverse events in 12 pooled, short-term, placebo-controlled clinical trials1

Tolerability profile visual

Adapted from TRINTELLIX Product Monograph.

The most commonly observed adverse events in patients with MDD treated with TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were nausea, constipation and vomiting.1

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Discontinuation rates observed in short-term studies (up to Week 8)

Discontinuation rates bar chart

The most common reason for discontinuation of TRINTELLIX in short-term studies (up to 8 weeks) was nausea. The incidence of nausea leading to withdrawal was 1.1% (TRINTELLIX 5 mg), 1.4% (TRINTELLIX 10 mg), 3.8% (TRINTELLIX 15 mg) and 3.3% (TRINTELLIX 20 mg) vs 0.3% for placebo. Withdrawing due to nausea was highest during the initial weeks of treatment.1

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Low incidence of self-reported sexual side effects demonstrated1

White male and female symbols inside an orange circle

The incidence of self-reported sexual side effects was low and similar to placebo in clinical short- and long-term studies with TRINTELLIX (5-20 mg/day)

Incidence of sexual dysfunction adverse reactions in a pool of 12 placebo-controlled clinical trials for MDD

Trintellix table of sexual dysfunction adverse events

In males only:

Trintellix table of male sexual dysfunction adverse events

In females only:

Trintellix table of female sexual dysfunction adverse events

TRINTELLIX was associated with higher incidences of treatment emergent sexual dysfunction compared with placebo, when evaluated by the Arizona Sexual Experiences (ASEX) scale

  • In females: TRINTELLIX 5 mg/day 22% (N=65), 10 mg/day 23% (N=94), 20 mg/day 34% (N=67), placebo 20% (N=135)
  • In males: TRINTELLIX 5 mg/day 16% (N=67), 10 mg/day 20% (N=86), 20 mg/day 29% (N=59), placebo 14% (N=162)

Physicians should routinely inquire about possible sexual side effects during treatment with TRINTELLIX.

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No clinically meaningful effect demonstrated on body weight1

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Mean weight change from baseline in a long-term (24-64 weeks), placebo-controlled study: +0.4 kg for TRINTELLIX 5 or 10 mg/day, +0.1 kg for placebo.

Percent of patients with weight gain or decrease of ≥7%

Trintellix body weight bar chart

No clinically significant effect demonstrated on ECG parameters1

White heart inside an orange circle

TRINTELLIX has not been associated with any clinically significant effect on ECG parameters, including QT, QTc, PR and QRS intervals, or with any arrhythmogenic potential.

ECG=electrocardiogram; MDD=major depressive disorder

Reference: 1. TRINTELLIX Product Monograph. Lundbeck Canada Inc., May 27, 2024.

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