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Safety Information
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.