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.

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Dosing

Convenient Once-Daily Dosing1

Decrease to a minimum of 5 mg once daily may be considered for patients who do not tolerate higher doses.1 

STARTING AND RECOMMENDED DOSE

10 mg once daily in adults <65 years of age.1

Depending on individual patient response, the dose may be increased to a maximum of 20 mg once daily, as tolerated.1 

Patients ≥65 years of age

  • 5 mg once-daily starting dose
  • 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.1

May be taken with or without food1

Pharmacokinetics

Absorption

TRINTELLIX (vortioxetine) is slowly but well absorbed after oral administration and the peak plasma concentration is reached within 7 to 11 hours. Following multiple dosing of 5, 10 and 20 mg/day, mean Cmax values of 9 to 33 ng/mL were observed. The absolute bioavailability is 75%. No effect of food on the pharmacokinetics was observed.

Distribution

The mean volume of distribution is 2,600 L, indicating extensive extravascular distribution. Vortioxetine is highly bound to plasma proteins (98-99%) and the binding appears to be independent of vortioxetine plasma concentrations.

Metabolism

TRINTELLIX (vortioxetine) is extensively metabolized, primarily through oxidation and subsequent glucuronic acid conjugation. 

Elimination

The mean elimination half-life and oral clearance are 66 hours and 33 L/h, respectively. Approximately 2/3 of the inactive vortioxetine metabolites are excreted in the urine and approximately 1/3 in the faeces. Only negligible amounts of unchanged vortioxetine are excreted in the urine.

CANMAT=Canadian Network for Mood and Anxiety Treatments

* Not available in Quebec.

† See guidelines for complete recommendations.

References: 1. TRINTELLIX Product Monograph. Lundbeck Canada Inc., May 27, 2024. 2. Lam RW, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults. Can J Psychiatry 2024:1-47.

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