TRINTELLIX® (vortioxetine) is indicated for the treatment of Major Depressive Disorder (MDD) in adults.

Patient portrayal. 
Individual results may vary.

Dosing &
Administration

How does dosing fit into the story?

TRINTELLIX HAS ONCE-DAILY ORAL DOSING WITH OR WITHOUT FOOD1

TRINTELLIX IS AVAILABLE IN 3 STRENGTHS

THE DOSAGE SHOULD BE INCREASED TO 20 MG/DAY, AS TOLERATED.1

Recommended starting dose: TRINTELLIX (vortioxetine) 10 mg once daily. Increase as tolerated to TRINTELLIX (vortioxetine) 20 mg once daily, or continue on TRINTELLIX (vortioxetine) 10 mg once daily, 5 mg tablets may be used for titration in patients who do not tolerate higher doses.

Tablets shown not actual size.

  • The efficacy and safety of doses above 20 mg/day have not been evaluated1
  • Prior to initiating treatment with TRINTELLIX, screen patients for personal or family history of bipolar disorder, mania, or hypomania1
  • The maximum dose is 10 mg/day in patients who are known CYP2D6 poor metabolizers1
  • Although patients can abruptly discontinue therapy with TRINTELLIX, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for 1 week prior to discontinuation1
    • In placebo-controlled trials, some patients experienced transient adverse reactions, such as headache and muscle tension, following abrupt discontinuation
  • Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX1

For additional dosing information, please see the Full Prescribing Information.

Drug interactions

Clinically important drug interactions with TRINTELLIX1

Drug ClassClinical Impact & Recommendations

Monoamine Oxidase Inhibitors

selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue

CONCOMITANT USE WITH TRINTELLIX INCREASES THE RISK OF SEROTONIN SYNDROME

MAOIs for psychiatric disorders are contraindicated with TRINTELLIX or within 21 days of stopping TRINTELLIX.

TRINTELLIX is contraindicated within 14 days of stopping MAOIs for psychiatric disorders.

Starting TRINTELLIX in patients on linezolid or IV methylene blue is also contraindicated.

Other Serotonergic Drugs

Other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort

CONCOMITANT USE WITH TRINTELLIX INCREASES THE RISK OF SEROTONIN SYNDROME

Monitor for serotonin syndrome when TRINTELLIX is coadministered with other serotonergic drugs.

If serotonin syndrome occurs, discontinue TRINTELLIX and other serotonergic drugs, and initiate supportive treatment.

Strong CYP2D6 Inhibitors

bupropion, fluoxetine, paroxetine, quinidine

CONCOMITANT USE WITH TRINTELLIX INCREASES TRINTELLIX PLASMA LEVELS

Reduce the TRINTELLIX dose by half.

When discontinuing a strong CYP2D6 inhibitor, increase TRINTELLIX to its original dose.

Strong CYP Inducers

rifampin, carbamazepine, phenytoin

CONCOMITANT USE WITH TRINTELLIX DECREASES TRINTELLIX PLASMA LEVELS

Consider increasing the dose of TRINTELLIX when coadministered for more than 14 days.

The maximum TRINTELLIX dose should not be greater than three times the original TRINTELLIX dose.

When discontinuing a strong CYP inducer, reduce TRINTELLIX within 14 days to its original dose.

Antiplatelet Drugs and Anticoagulants

aspirin, clopidogrel, heparin, warfarin

CONCOMITANT USE WITH TRINTELLIX MAY POTENTIATE BLEEDING RISK

Inform patients of increased bleeding risk.

For patients on warfarin, monitor INR carefully when initiating, titrating or discontinuing TRINTELLIX.

Drugs Highly Bound to Plasma Protein

warfarin

CONCOMITANT USE WITH TRINTELLIX MAY INCREASE FREE TRINTELLIX PLASMA LEVELS OR OTHER HIGHLY PROTEIN-BOUND DRUG LEVELS

Monitor for adverse reactions.

Reduce dosage of TRINTELLIX or other highly protein-bound drugs as needed.

Note: Class examples do not include all possible class members.

Abbreviations: INR, International Normalized Ratio; IV, Intravenous; MAOIs, Monoamine oxidase inhibitors; NSAIDs, Nonsteroidal anti-inflammatory drugs; SNRIs, Serotonin-norepinephrine reuptake inhibitors; SSRIs, Selective serotonin reuptake inhibitors.

For additional Drug Interactions information, please see the ​​​Full Prescribing Information.

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  1. Trintellix (vortioxetine) prescribing information. Takeda Pharmaceuticals.
  2. Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of LuAA21004 in patients with Major Depressive Disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
  3. Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with Major Depressive Disorder. J Clin Psychiatry. 2012;73(7):953-959.
  4. Boulenger J-P, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with Major Depressive Disorder. Int Clin Psychopharmacol. 2014;29(3):138-149.
  5. Mahableshwarkar AR, Jacobsen P, Chen Y, Serenko M, Trivedi MH. A randomized, double-blind, duloxetine‑referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015;232(12):2061-2070.
  6. Jacobsen P, Mahableshwarkar AR, Serenko M, Chan S, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with Major Depressive Disorder. J Clin Psychiatry. 2015;76(5):575-582.
  7. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with Major Depressive Disorder. Int Clin Psychopharmacol. 2012;27(4):215-223.
  8. McIntyre RS, Lophaven S, Olsen CK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol. 2014;17(10):1557-1567.
  9. Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RSE. A randomized, placebo-controlled, active-reference, double-blind, flexible-dose study of the efficacy of vortioxetine on cognitive function in Major Depressive Disorder. Neuropsychopharmacology. 2015;40(8):2025-2037.
  10. Data on file. Takeda Pharmaceuticals.
  11. Data on file. Lundbeck.
  12. Boulenger J-P, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with Major Depressive Disorder. J Psychopharmacol. 2012;26(11):1408-1416.
  13. Jacobsen PL, Mahableshwarkar AR, Chen Y, Chrones L, Clayton AH. Effect of vortioxetine vs. escitalopram on sexual functioning in adults with well‑treated Major Depressive Disorder experiencing SSRI-induced sexual dysfunction. J Sex Med. 2015;12(10):2036-2048.
  14. Kambeitz JP, Howes OD. The serotonin transporter in depression: Meta-analysis of in vivo and post mortem findings and implications for understanding and treating depression. J Affect Disord. 2015;186:358-366.
  15. American Psychiatric Association. Depressive disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th edition (DSM-5®). Arlington, VA: American Psychiatric Association; 2013:155-188.
  16. ICD-10-CM Tabular list of diseases and injuries. Centers for Medicare & Medicaid Services. Published 2022. https://www.cms.gov/files/zip/2022-code-tables-tabular-and-index-updated-02012022.zip. Accessed August 19, 2022.