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Uses of Trintellix
Trintellix is a prescription medication used to treat major depressive disorder (MDD).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
What should I discuss with my healthcare provider before taking vortioxetine?
You should not use this medicine if you are allergic to vortioxetine, or if you are being treated with linezolid or methylene blue injection.
Do not use an MAO inhibitor within 14 days before you take vortioxetine. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.
Vortioxetine is not approved for use by anyone younger than 18 years old.
To make sure vortioxetine is safe for you, tell your doctor if you have:
bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;
seizures or epilepsy;
bleeding or blood clotting disorder; or
low levels of sodium in your blood.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Taking vortioxetine in the last 3 months of pregnancy may cause problems in the newborn, such as life-threatening withdrawal symptoms, serious lung problems or other complications in the baby. Tell your doctor if you are pregnant.
Follow your doctor's instructions about taking vortioxetine if you are pregnant. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant. Vortioxetine may cause harm to an newborn baby, but you may have a relapse of major depressive disorder or other problems if you stop taking your medicine during pregnancy. The benefit of continuing treatment with vortioxetine may outweigh any risks to the baby.
It is not known whether vortioxetine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Uses for Trintellix
Major Depressive Disorder
Treatment of major depressive disorder in adults.1 2 3 4 5 6 7 12 13
APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, tricyclic antidepressants (TCAs), MAO inhibitors, and other antidepressants (e.g., bupropion, mirtazapine, trazodone).15 Choose antidepressant based mainly on the following factors: patient preference; nature of prior response to medication; safety, tolerability, and anticipated adverse effects; concurrent psychiatric and medical conditions; specific properties of the medication (e.g., half-life, actions on CYP isoenzymes, other drug interactions); and cost.15 For most patients, an SSRI, SNRI, mirtazapine, or bupropion is considered optimal.15 Consult APA’s Practice Guidelines for the Treatment of Patients with Major Depressive Disorder (at ) for additional information.15
Trintellix Dosage and Administration
Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor intended to treat psychiatric disorders and initiation of vortioxetine and allow at least 3 weeks to elapse between discontinuance of vortioxetine and initiation of MAO inhibitor therapy intended to treat psychiatric disorders.1 (See Contraindications and Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 43 44 45 (See Worsening of Depression and Suicidality Risk under Cautions.)
Although vortioxetine can be abruptly discontinued, transient adverse reactions (including headache, muscle tension, mood swings, sudden outbursts of anger, dizziness, runny nose) reported in the first week following abrupt discontinuance of dosages of 15 or 20 mg daily.1 Manufacturer recommends decreasing dosage to 10 mg daily for one week before full discontinuance in patients receiving 15 or 20 mg of the drug daily, if possible.1
Administer orally once daily, without regard to meals, at approximately the same time each day.1
Use caution in prescribing and dispensing due to similarities in spelling and pronunciation of Brintellix (former trade name for vortioxetine; changed to Trintellix in May 2016) and Brilinta (ticagrelor).49 (See Prescribing and Dispensing Precautions under Cautions.)
Available as vortioxetine hydrobromide; dosage expressed in terms of vortioxetine.1
AdultsMajor Depressive Disorder Oral
Initially, 10 mg once daily.1 Increase dosage to 20 mg daily, as tolerated, since higher dosages demonstrated better efficacy in US clinical trials.1 In the main clinical trials, dosage increases were made after the first week of therapy.1 Efficacy and safety of dosages >20 mg daily not evaluated in controlled trials.1 Consider decreasing dosage to 5 mg once daily in patients who do not tolerate higher dosages.1
In poor metabolizers of CYP2D6, maximum recommended dosage is 10 mg once daily.1
If used with a potent CYP2D6 inhibitor, a 50% reduction in vortioxetine dosage is required.1 If used with a potent CYP inducer for >14 days, consider increasing dosage of vortioxetine.1 (See Interactions.)
Optimum duration not established; may require several months or longer of sustained antidepressant therapy.1 15
Mild or moderate hepatic impairment: Dosage adjustment not necessary.1
Severe hepatic impairment: Not studied; use not recommended.1
Dosage adjustment not necessary in patients with renal impairment (ranging from mild impairment to end-stage renal disease).1 (See Renal Impairment under Cautions.)
Dosage adjustment not necessary.1
Dosage adjustment based on gender not necessary.1
Race or Ethnicity
Dosage adjustment based on race or ethnicity not necessary.1
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
5 mg (of vortioxetine)
10 mg (of vortioxetine)
15 mg (of vortioxetine)
20 mg (of vortioxetine)
Uses For Trintellix
Vortioxetine is used to treat depression. It works in the brain to help reduce depression symptoms and is an antidepressant.
This medicine is available only with your doctor's prescription.
How is this medicine (Trintellix) best taken?
Use Trintellix as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Take this medicine at the same time of day.
- Keep taking Trintellix as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Change in how you act.
- Not able to sleep.
- Very bad dizziness or passing out.
- Change in sex ability.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
CNS Active Agents
Monoamine Oxidase Inhibitors
Adverse reactions, some of which are serious or fatal, can develop in patients who use MAOIs or who have recently been discontinued from an MAOI and started on a serotonergic antidepressant(s) or who have recently had SSRI or SNRI therapy discontinued prior to initiation of an MAOI [see Dosage and Administration (2.4), Contraindications (4) and Warnings and Precautions (5.2)].
Based on the mechanism of action of Trintellix and the potential for serotonin toxicity, serotonin syndrome may occur when Trintellix is coadministered with other drugs that may affect the serotonergic neurotransmitter systems (e.g., SSRIs, SNRIs, triptans, buspirone, tramadol, and tryptophan products etc.). Closely monitor symptoms of serotonin syndrome if Trintellix is coadministered with other serotonergic drugs. Treatment with Trintellix and any concomitant serotonergic agents should be discontinued immediately if serotonin syndrome occurs [see Warnings and Precautions (5.2)].
Other CNS Active Agents
No clinically relevant effect was observed on steady state lithium exposure following coadministration with multiple daily doses of Trintellix. Multiple doses of Trintellix did not affect the pharmacokinetics or pharmacodynamics (composite cognitive score) of diazepam. A clinical study has shown that Trintellix (single dose of 20 or 40 mg) did not increase the impairment of mental and motor skills caused by alcohol (single dose of 0.6 g/kg). Details on the potential pharmacokinetic interactions between Trintellix and bupropion can be found in Section 7.3.
Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of case-control and cohort design have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin.
Following coadministration of stable doses of warfarin (1 to 10 mg/day) with multiple daily doses of Trintellix, no significant effects were observed in INR, prothrombin values or total warfarin (protein bound plus free drug) pharmacokinetics for both R- and S-warfarin [see Drug Interactions (7.4)]. Coadministration of aspirin 150 mg/day with multiple daily doses of Trintellix had no significant inhibitory effect on platelet aggregation or pharmacokinetics of aspirin and salicylic acid [see Drug Interactions (7.4)]. Patients receiving other drugs that interfere with hemostasis should be carefully monitored when Trintellix is initiated or discontinued [see Warnings and Precautions (5.3)].
Potential for Other Drugs to Affect Trintellix
Reduce Trintellix dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, quinidine) is coadministered. Consider increasing the Trintellix dose when a strong CYP inducer (e.g., rifampin, carbamazepine, phenytoin) is coadministered. The maximum dose is not recommended to exceed three times the original dose [see Dosage and Administration (2.5 and 2.6)] (Figure 1).
Figure 1. Impact of Other Drugs on Vortioxetine PK
Potential for Trintellix to Affect Other Drugs
No dose adjustment for the comedications is needed when Trintellix is coadministered with a substrate of CYP1A2 (e.g., duloxetine, caffeine), CYP2A6, CYP2B6 (e.g., bupropion), CYP2C8 (e.g., repaglinide), CYP2C9 (e.g., S-warfarin, tolbutamide), CYP2C19 (e.g., diazepam), CYP2D6 (e.g., venlafaxine, dextromethorphan), CYP3A4/5 (e.g., budesonide, midazolam), P-gp (e.g., digoxin), BCRP (e.g., methotrexate), OATP1B1/3 (e.g., rosuvastatin) and OCT2 (e.g., metformin). In addition, no dose adjustment for lithium, aspirin, and warfarin is necessary.
Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1 and OCT2. As such, no clinically relevant interactions with drugs metabolized/transported by these CYP enzymes or transporters would be expected.
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes. Chronic administration of Trintellix is unlikely to induce the metabolism of drugs metabolized by these CYP isoforms. Furthermore, in a series of clinical drug interaction studies, coadministration of Trintellix with substrates for CYP2B6 (e.g., bupropion), CYP2C9 (e.g., warfarin), and CYP2C19 (e.g., diazepam), had no clinical meaningful effect on the pharmacokinetics of these substrates (Figure 2).
Because vortioxetine is highly bound to plasma protein, coadministration of Trintellix with another drug that is highly protein bound may increase free concentrations of the other drug. However, in a clinical study with coadministration of Trintellix (10 mg/day) and warfarin (1 mg/day to 10 mg/day), a highly protein-bound drug, no significant change in INR was observed [see Drug Interactions (7.2)].
Figure 2. Impact of Vortioxetine on PK of Other Drugs
There is limited clinical trial experience regarding human overdosage with Trintellix. In pre-marketing clinical studies, cases of overdose were limited to patients who accidentally or intentionally consumed up to a maximum dose of 40 mg of Trintellix. The maximum single dose tested was 75 mg in men. Ingestion of Trintellix in the dose range of 40 to 75 mg was associated with increased rates of nausea, dizziness, diarrhea, abdominal discomfort, generalized pruritus, somnolence, and flushing.
Management of Overdose
No specific antidotes for Trintellix are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.
Trintellix is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is:
Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water.
Each Trintellix tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in Trintellix tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).
Patient Counseling Information
See FDA-approved patient labeling (Medication Guide)
Advise patients and their caregivers about the benefits and risks associated with treatment with Trintellix and counsel them in its appropriate use. Advise patients and their caregivers to read the Medication Guide and assist them in understanding its contents. The complete text of the Medication Guide is reprinted at the end of this document.
Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or down [see Boxed Warning and Warnings and Precautions (5.1)].
Discontinuation of Treatment
Patients who are on Trintellix 15 mg/day or 20 mg/day may experience headache, muscle tension, mood swings, sudden outburst of anger, dizziness and runny nose if they abruptly stop their medicine. Advise patients not stopping Trintellix without talking to their healthcare provider [see Adverse Reactions (6)].
Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications because of a potential for interactions. Instruct patients not to take Trintellix with an MAOI or within 14 days of stopping an MAOI and to allow 21 days after stopping Trintellix before starting an MAOI [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.2), and Drug Interactions (7.1)].
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Trintellix and triptans, tricyclic antidepressants, fentanyl, Lithium, tramadol, tryptophan supplements, and St. John's Wort supplements [see Warnings and Precautions (5.2) and Drug Interactions (7.1, 7.2)].
Caution patients about the increased risk of abnormal bleeding when Trintellix is given with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation [see Warnings and Precautions (5.3)].
Activation of Mania/Hypomania
Advise patients and their caregivers to look for signs of activation of mania/hypomania [see Warnings and Precautions (5.4)].
Angle Closure Glaucoma
Patients should be advised that taking Trintellix can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.5)].
Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking Trintellix [see Warnings and Precautions (5.6)].
Advise patients that nausea is the most common adverse reaction, and is dose related. Nausea commonly occurs within the first week of treatment, then decreases in frequency but can persist in some patients.
A clinical study has shown that Trintellix (single dose of 20 or 40 mg/day) did not increase the impairment of mental and motor skills caused by alcohol.
Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing.
Advise a pregnant woman or a woman planning to become pregnant that Trintellix may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1)].
Distributed and marketed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
Deerfield, IL 60015
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.
©2013-2017 Takeda Pharmaceuticals America, Inc.
|This Medication Guide has been approved by the U.S. Food and Drug Administration||LUN205 R14 Revised: April 2017|
|MEDICATION GUIDE |
What is the most important information I should know about Trintellix?
|Trintellix and other antidepressant medicines may cause serious side effects. |
|Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:|
| || || |
|What is Trintellix?|
|Trintellix is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD).|
|It is important to talk with your healthcare provider about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare provider. |
|Do not take Trintellix if you: |
|Before taking Trintellix, tell your healthcare provider about all of your medical conditions, including if you: |
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Trintellix and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.|
|Especially tell your healthcare provider if you take: |
|Ask your healthcare provider if you are not sure if you are taking any of these medicines.|
|Before you take Trintellix with any of these medicines, talk to your healthcare provider about serotonin syndrome. See "What are the possible side effects of Trintellix?"|
|How should I take Trintellix? |
| || |
What are the possible side effects of Trintellix?
|Trintellix may cause serious side effects, including: |
| || || || |
|Common side effects in people who take Trintellix include: |
|These are not all the possible side effects of Trintellix. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store Trintellix?|
|Store Trintellix at room temperature between 59°F to 86°F (15°C to 30°C).|
|Keep Trintellix and all medicines out of the reach of children.|
|General information about the safe and effective use of Trintellix.|
|Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Trintellix for a condition for which it was not prescribed. Do not give Trintellix to other people, even if they have the same symptoms that you have. It may harm them.|
|You can ask your pharmacist or healthcare provider for information about Trintellix that is written for healthcare professionals.|
|What are the ingredients in Trintellix?|
|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)|
|Distributed and Marketed by: |
Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015
|Marketed by: |
Lundbeck, Deerfield, IL 60015
|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.|
|All other trademarks are the property of their respective owners.|
|©2013-2017 Takeda Pharmaceuticals America, Inc.|
|For more information, go to www.Trintellix.com or call 1-877-TAKEDA-7 (1-877-825-3327).|