Vortioxetine

What is Vortioxetine?

• Vortioxetine (TRINTELLIX) is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant used for the treatment of major depressive disorder (MDD) in adults.

What are the uses of this medicine?

• This medicine is used in adults to treat a certain type of depression called Major Depressive Disorder (MDD).

How does this medicine work?

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

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to vortioxetine or any of the ingredients in TRINTELLIX. See the end of this Medication Guide for a complete list of ingredients in TRINTELLIX
• take a Monoamine Oxidase Inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue

What drug interactions can this medicine cause?

• The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs(eg: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue) increases the risk of serotonin syndrome.
• Concomitant use of TRINTELLIX with other serotonergic drugs (eg: Other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome.
• Concomitant use of TRINTELLIX with strong CYP2D6 inhibitors (eg: bupropion, fluoxetine, paroxetine, quinidine) increases plasma concentrations of vortioxetine.
• Concomitant use of TRINTELLIX with a strong CYP inducer (eg:rifampin, carbamazepine, phenytoin) decreases plasma concentrations of vortioxetine.
• Concomitant use of TRINTELLIX with an antiplatelet or anticoagulant drug (eg:aspirin, clopidogrel, heparin, warfarin) may potentiate the risk of bleeding.
• TRINTELLIX is highly bound to plasma protein. The concomitant use of TRINTELLIX with another drug that is highly bound to plasma protein (eg: Warfarin) may increase free concentrations of TRINTELLIX.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

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

Recommended Dosage:

• The recommended starting dose is 10 mg administered orally once daily without regard to meals.
• Dosage should then be increased to 20 mg/day, as tolerated.
• Consider 5 mg/day for patients who do not tolerate higher doses.

Discontinuing Treatment:

• TRINTELLIX can be discontinued abruptly.
• However, 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.

Use of TRINTELLIX in Known CYP2D6 Poor Metabolizers or in Patients Taking Strong CYP2D6 Inhibitors:

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

Administration

• Take TRINTELLIX exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of TRINTELLIX until it is the right dose for you.
• Take TRINTELLIX 1 time each day.
• TRINTELLIX may be taken with or without food.
• If you take too much TRINTELLIX, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 10 mg and 20 mg

This medicine is available in fallowing brand namesː

• TRINTELLIX ;Brintellix

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• constipation
• vomiting

TRINTELLIX may cause serious side effects, including:

• Increased risk of suicidal thoughts and actions
• Serotonin syndrome
• Increased risk of bleeding
• Manic episodes
• Discontinuation syndrome
• Eye problems (angle-closure glaucoma)
• Low levels of sodium in your blood (hyponatremia)

What special precautions should I follow?

• The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants including TRINTELLIX. Increased risk when co-administered with other serotonergic agents (SSRIs, SNRIs, and triptans), but also when taken alone. If it occurs, discontinue TRINTELLIX and initiate supportive measures.
• The use of drugs that interfere with serotonin reuptake inhibition, including TRINTELLIX, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk.
• In patients with bipolar disorder, treating a depressive episode with TRINTELLIX or another antidepressant may precipitate a mixed/manic episode. Screen patients for bipolar disorder.
• Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• Hyponatremia has occurred as a result of treatment with serotonergic drugs, including TRINTELLIX.
• Adverse reactions have been reported upon abrupt discontinuation of treatment with TRINTELLIX at doses of 15 mg/day and 20 mg/day. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• dizziness
• diarrhea
• abdominal discomfort
• generalized pruritus
• somnolence
• flushing
• vomiting
• seizure
• serotonin syndrome in combination with another serotonergic drug

Management of overdosage:

• No specific antidotes for TRINTELLIX are known.
• In managing overdosage, consider the possibility of multiple drug involvement.
• In case of overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

Can this medicine be used in pregnancy?

• There are limited human data on TRINTELLIX use during pregnancy to inform any drug-associated risks.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.
• Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

Can this medicine be used in children?

• The safety and effectiveness of TRINTELLIX have not been established in pediatric patients for the treatment of MDD.
• Antidepressants, such as TRINTELLIX, increase the risk of suicidal thoughts and behaviors in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: vortioxetine hydrobromide
• Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating consisting of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)

Who manufactures and distributes this medicine?

Distributed and Marketed by:

• Takeda Pharmaceuticals America, Inc. Lexington, MA 02421

• Marketed by: Lundbeck, Deerfield

TRINTELLIX is a trademark of H. Lundbeck A/S registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

What should I know about storage and disposal of this medication?

• Store TRINTELLIX at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TRINTELLIX and all medicines out of the reach of children.

• Dailymed label info on Vortioxetine
• FDA Vortioxetine

Vortioxetine Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone

The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone