Safety Information

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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.

Tolerability Profile

PrTrintellix® has an excellent tolerability profile1

Adapted from the 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

Low incidence of self-reported sexual side effects demonstrated1

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)

  • Incidences for Trintellix and placebo, respectively, were: libido decreased (0.7%, 0.6%), orgasm abnormal (0.3%, 0.2%), anorgasmia (0.2%, 0%), loss of libido (0.2%, 0%), disturbance in sexual arousal (<0.1%, 0%), orgasmic sensation decreased (<0.1%, <0.1%), sexual dysfunction (<0.1%, <0.1%)
  • In males only: ejaculation delayed (0.5%, 0.1%), erectile dysfunction (0.3%, 0.4%), ejaculation disorder (<0.1%, 0%); in females only: vulvovaginal dryness (<0.1%, 0%)

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.

No clinically meaningful effect demonstrated on body weight1

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.

No clinically significant effect demonstrated on ECG parameters1

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., August 4, 2021.

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