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.

Dosing

Convenient Once-Daily Dosing1

May be taken with or without food1

Starting and recommended dose1

Dosage adjustment1

Patients ≥65 years of age1 
5 mg once-daily starting dose1

  • Caution is advised when treating elderly patients with doses >10 mg/day due to the limited efficacy and safety data from patients of 65 years of age or older who were treated with these doses in controlled clinical trials

Trintellix is covered by the Ontario Drug Benefit, RAMQ*, Alberta Health, Manitoba Pharmacare, the Saskatchewan Drug Plan, British Columbia Pharmacare (special authorization), the NBPDP†, the NLPDP‡, NIHB§, Veterans Affairs Canada, Correctional Service Canada, Yukon Pharmacare Plan, Nova Scotia, Prince Edward Island and the Northwest Territories health benefits program.2

Covered by most private insurance plans2

Vortioxetine is recommended as a first-line treatment in the 2016 CANMAT Guidelines3¶

CANMAT=Canadian Network for Mood and Anxiety Treatments

* RAMQ=Official Mark of the Régie de l'assurance maladie du Québec.
† NBPDP=New Brunswick Prescription Drug Program.
‡ NLPDP=Newfoundland and Labrador Prescription Drug Program.
§ NIHB=Non-insured health benefit.
¶ See guidelines for complete recommendations.

References: 1. Trintellix Product Monograph. Lundbeck Canada Inc., August 4, 2021. 2. Data on file. Trintellix Coverage Canada. Lundbeck. December 2021. 3. Kennedy SH, Lam RW, McIntyre RS, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the management of adults with major depressive disorder: Section 3. Pharmacological treatments. Can J Psychiatry
2016;61(9):540-60.

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