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

Patient portrayal.
Individual results may vary.

FAQs

Selective serotonin reuptake inhibitors (SSRIs) are a common type of antidepressant used to treat Major Depressive Disorder (MDD) by enhancing specific serotonergic activity in the CNS.14

The mechanism of the antidepressant effect of TRINTELLIX is not fully understood, although it is thought to be related to its enhancement of serotonergic activity through inhibition of the reuptake of serotonin (5-HT).1 It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to TRINTELLIX's antidepressant effect has not been established.

For descriptions and symptoms of MDD, and a hypothetical patient profile, please see Diagnostic Criteria & Patient Profile. 

The mean terminal half-life of TRINTELLIX is approximately 66 hours, and steady-state plasma concentrations are typically achieved within two weeks of dosing.1

Multiple drugs have the potential to interact with TRINTELLIX, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRINTELLIX and some drugs should not be taken concomitantly as co-administration may lead to serious side effects or decreases in efficacy.1

See below for clinically important interactions with TRINTELLIX.1

NOTE: this is not an exhaustive list of TRINTELLIX drug interactions. Please see the Full Prescribing Information for further information.

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact

The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome.

Intervention

Concomitant use of TRINTELLIX is contraindicated:

  • With an MAOI intended to treat psychiatric disorders or within 21 days of stopping treatment with TRINTELLIX.
  • Within 14 days of stopping an MAOI intended to treat psychiatric disorders.
  • In a patient who is being treated with linezolid or intravenous methylene blue.
Examples

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

Other Serotonergic Drugs

Clinical Impact

Concomitant use of TRINTELLIX with other serotonergic drugs increases the risk of serotonin syndrome.

Intervention

Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of TRINTELLIX and/or concomitant serotonergic drugs.

Examples

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

Strong Inhibitors of CYP2D6

Clinical Impact

Concomitant use of TRINTELLIX with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine.

Intervention

Reduce TRINTELLIX dose by half when a strong CYP2D6 inhibitor is coadministered.

Examples

bupropion, fluoxetine, paroxetine, quinidine

Strong CYP Inducers

Clinical Impact

Concomitant use of TRINTELLIX with strong CYP inducer decreases plasma concentrations of vortioxetine.

Intervention

Consider increasing the TRINTELLIX dose when a strong CYP inducer is coadministered. The maximum dose is not recommended to exceed three times the original dose.

Examples

rifampin, carbamazepine, phenytoin

Drugs that interfere with Hemostasis (antiplatlet agents and anticoagulants)

Clinical Impact

Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding.

Intervention

Inform patients of the increased risk of bleeding associated with the concomitant use of TRINTELLIX and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

Examples

aspirin, clopidogrel, heparin, warfarin

Drugs Highly Bound to Plasma Protein

Clinical Impact

TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein may increase free concentrations of TRINTELLIX or other tightly-bound drugs in plasma.

Intervention

Monitor for adverse reactions and reduce dosage of TRINTELLIX or other protein bound drugs as warranted.

Examples

warfarin

The list price for TRINTELLIX is $489.67 for a 30-day prescription.* Eligible commercially insured patients may pay as little as $10 for either a 30-day or 90-day prescription with the TRINTELLIX savings card.† Savings of up to $100 per 30-day or $300 per 90-day prescription, with a maximum total savings of up to $1,300 over one year. Restrictions apply.

TRINTELLIX is available for ~85% of commercially insured patients in the US without prior authorization (PA).‡

For more information about savings or for coverage in your area, visit Savings & Support.

*As of 01/01/2024.
†See the savings card for Eligibility Requirements and Terms & Conditions.
‡Formulary data are provided by Fingertip Formulary® and are current as of September 2022. Check the patient’s individual health plan for coverage and cost information, which may change without notice.

Contact your local sales rep to request samples; if you don’t have one, you can request a rep here.

If you would like to have TRINTELLIX samples shipped to your office, please visit MySampleCloset and follow the steps below:

  • Login or register to create a new account (upon initial login, you may be prompted to complete a few security questions)
  • View the list of products and select TRINTELLIX
  • Place and submit your order. Maximum order quantities are listed on the site, one order may be placed per month.

Please note that when a TRINTELLIX sample order is placed on the MySampleCloset website, your local Takeda representative will be notified so that they can expedite delivery by bringing them to your office personally. If the representative is unable to deliver your order, the samples will be shipped to your office.

TRINTELLIX is available in 5 mg, 10 mg, and 20 mg tablets.1

For more information, visit our Dosing page, or see Full Prescribing Information.

The recommended starting dose of TRINTELLIX is 10 mg administered orally once daily without regard to meals.1 Dosage can then be titrated to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses.

Prior to initiating treatment with TRINTELLIX, screen patients for personal or family history of bipolar disorder, mania, or hypomania.1

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 one week prior to full discontinuation if possible.1

The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers.1

In placebo-controlled trials, some patients taking more than 10 mg/day experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation.1

For more information, visit our Dosing page, or see Full Prescribing Information.

This reflects the FDA-approved label dosage information. Neither Takeda nor Lundbeck can suggest treatment approaches or make recommendations for the management of patients.

For full information on treatment-related side effects and adverse reactions, see Safety Data, Important Safety Information, and 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.