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.

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