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Frequently asked questions

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 professional about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare professional. Talk to your healthcare professional if you do not think that your condition is getting better with TRINTELLIX treatment.

What is the most important information
I should know about TRINTELLIX?

TRINTELLIX and other antidepressant medicines may cause serious side effects.

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
  2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions?
    • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed
    • Call your healthcare professional right away to report new or sudden changes in mood, behavior, thoughts, or feelings
    • Keep all follow-up visits with your healthcare professional as scheduled. Call your healthcare professional between visits as needed, especially if you have concerns about symptoms
    Call your healthcare professional right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
    • Attempts to commit suicide
    • Acting on dangerous impulses
    • Acting aggressive, being angry, or violent
    • Thoughts about suicide or dying
    • New or worse depression
    • New or worse anxiety
    • Feeling agitated, restless, angry, or irritable
    • Trouble sleeping
    • An extreme increase in activity or talking (mania)
    • Other unusual changes in behavior or mood
    • Panic attacks
    • New or worse irritability

Who should not take TRINTELLIX?

Do not take TRINTELLIX if you:
  • Are allergic to vortioxetine, or any of the ingredients in TRINTELLIX (see below for the full list of ingredientssee the full list of ingredients in this guide)
  • Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare professional or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid

Do not take an MAOI within 21 days of stopping TRINTELLIX. Do not start TRINTELLIX if you stopped taking an MAOI in the last 14 days.

What should I tell my healthcare professional
before taking TRINTELLIX?

Tell your healthcare professional if you:
  • Have liver problems
  • Have or had seizures or convulsions
  • Have mania or bipolar disorder (manic depression)
  • Have low salt (sodium) levels in your blood
  • Have or had bleeding problems
  • Drink alcohol
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. It is not known if TRINTELLIX will harm your unborn baby. Taking TRINTELLIX while pregnant in your third trimester may cause your newborn baby to have withdrawal symptoms that causes a certain type of breathing problem called Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Are breastfeeding or plan to breastfeed. It is not known if TRINTELLIX passes into breast milk. Talk to your healthcare professional about the best way to feed your baby if you take TRINTELLIX

Will TRINTELLIX interfere with other medications?

Tell your healthcare professional about all the medicines that 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 professional if you take:
  • Medicines used to treat migraine headache (e.g., triptans)
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), buspirone, or antipsychotics
  • MAOIs (including linezolid, an antibiotic)
  • Tramadol or fentanyl
  • Over-the-counter supplements such as tryptophan or St. John's Wort
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Aspirin
  • Warfarin (Coumadin, Jantoven)
  • Diuretics
  • Rifampin
  • Carbamazepine
  • Phenytoin
  • Quinidine

Ask your healthcare professional 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 professional about serotonin syndrome. For more information, review the possible side effects of TRINTELLIX in the question below. Know the medicines you take. Keep a list of them to show your healthcare professional or pharmacist when you get new medicine.

How should I take TRINTELLIX?

  • Take TRINTELLIX exactly as your healthcare professionals tell you to take it
  • Take TRINTELLIX at about the same time each day
  • Your healthcare professional may need to change the dose of TRINTELLIX until it is the right dose for you
  • Do not start or stop taking TRINTELLIX without talking to your healthcare professional first. Suddenly stopping TRINTELLIX when you take higher doses may cause you to have side effects, including headache, stiff muscles, mood swings, sudden outbursts of anger, dizziness or feeling lightheaded, and runny nose.
  • TRINTELLIX may be taken with or without food.
  • If you take too much TRINTELLIX, call the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of TRINTELLIX?

TRINTELLIX may cause serious side effects, including:

  • See "What is the most important information I should know about TRINTELLIX?"
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as TRINTELLIX are taken with certain other medicines. Symptoms of serotonin syndrome may include:
    • Agitation, hallucinations, coma, or other changes in mental status
    • Problems controlling your movements or muscle twitching
    • Fast heartbeat
    • High or low blood pressure
    • Sweating or fever
    • Nausea or vomiting
    • Diarrhea
    • Muscle stiffness or tightness
  • Abnormal bleeding or bruising. TRINTELLIX may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
  • Hypomania (manic episodes). Symptoms of manic episodes include:
    • Greatly increased energy
    • Severe problems sleeping
    • Racing thoughts
    • Reckless behavior
    • Unusually grand ideas
    • Excessive happiness or irritability
    • Talking more or faster than usual
  • Visual problems
    • Eye pain
    • Changes in vision
    • Swelling or redness in or around the eye
  • Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

  • Low levels of salt (sodium) in your blood. Symptoms of this may include: headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet. Symptoms of severe or sudden cases of low salt levels in your blood may include: hallucinations (seeing or hearing things that are not real), fainting, seizures, and coma. If not treated, severe low sodium levels can cause death
Common side effects in people who take TRINTELLIX include:
  • Nausea
  • Constipation
  • Vomiting

Tell your healthcare professional if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRINTELLIX. For more information, ask your healthcare professional or pharmacist.

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.

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)

What other general information do I need to know
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 condition. It may harm them.

This FAQ page summarizesThese FAQ pages summarize the most important information about TRINTELLIX. If you would like more information, talk with your healthcare professional. You may ask your healthcare professional or pharmacist for information about TRINTELLIX that is written for healthcare professionals.

For more information, call 1-877-TAKEDA-7 (1-877-825-3327).

Tools & Resources
Important Safety Information About TRINTELLIX
Suicidal Thoughts and Actions and Antidepressant Drugs

Antidepressants may increase suicidal thoughts or actions in some children, teens or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. TRINTELLIX has not been evaluated for use in patients under 18.

Do not take TRINTELLIX if you:

  • Are allergic to vortioxetine or any of the ingredients in TRINTELLIX
  • Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid; do not take an MAOI within 21 days of stopping TRINTELLIX; do not start TRINTELLIX if you stopped taking an MAOI in the last 14 days

TRINTELLIX may cause serious side effects including:

Serotonin Syndrome: A potentially life-threatening problem that can happen when medicines such as TRINTELLIX are taken with certain other medicines. Symptoms may include agitation, hallucinations, coma or other changes in mental status; problems controlling movements or muscle twitching, stiffness or tightness; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea.

Abnormal bleeding or bruising: TRINTELLIX and other serotonergic antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

Manic episode: Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Visual problems: May include eye pain, changes in vision, swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Low salt (sodium) levels in the blood: Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet; and in severe or sudden cases hallucinations, fainting, seizures or coma. If not treated, severe low sodium levels can cause death.

Before starting TRINTELLIX, tell your healthcare provider if you have or had liver problems, seizures or convulsions, bipolar disorder (manic depression) or mania, low salt (sodium) levels in your blood, bleeding problems, drink alcohol, have any other medical conditions or if you are pregnant, nursing, plan to become pregnant, or plan to nurse.

TRINTELLIX and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together. Tell your healthcare provider if you plan on or are taking any other prescription and non-prescription medicines, vitamins and herbal supplements including medicines for migraine headaches, such as triptans; medicines used to treat mood, anxiety, psychotic or thought disorders such as tricyclics, lithium, SSRIs, SNRIs, bupropion, buspirone or antipsychotics; MAOIs including linezolid (a specific antibiotic); over-the-counter supplements such as tryptophan or St. John's wort; and the following medicines: aspirin, NSAIDs, warfarin (Coumadin®, Jantoven®), diuretics, rifampin, carbamazepine, phenytoin, quinidine, tramadol or fentanyl.

Common side effects of TRINTELLIX include: nausea, constipation or vomiting. These are not all the possible side effects of TRINTELLIX.

Do not start or stop taking TRINTELLIX without talking to your healthcare provider first. Suddenly stopping TRINTELLIX when you take higher doses may cause you to have side effects including headache, stiff muscles, mood swings, sudden outbursts of anger, dizziness or feeling lightheaded, or runny nose.

Talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication for TRINTELLIX

TRINTELLIX is a prescription medicine used to treat Major Depressive Disorder (MDD) in adults.

Please see Prescribing Information, including Medication Guide for TRINTELLIX.

Important Safety Information About TRINTELLIX
Suicidal Thoughts and Actions and Antidepressant Drugs

Antidepressants may increase suicidal thoughts or actions in some children, teens or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. TRINTELLIX has not been evaluated for use in patients under 18.

Do not take TRINTELLIX if you:

TRINTELLIX may cause serious side effects including:

Serotonin Syndrome: A potentially life-threatening problem that can happen when medicines such as TRINTELLIX are taken with certain other medicines. Symptoms may include agitation, hallucinations, coma or other changes in mental status; problems controlling movements or muscle twitching, stiffness or tightness; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea.

Abnormal bleeding or bruising: TRINTELLIX and other serotonergic antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

Manic episode: Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Visual problems: May include eye pain, changes in vision, swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Low salt (sodium) levels in the blood: Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet; and in severe or sudden cases hallucinations, fainting, seizures or coma. If not treated, severe low sodium levels can cause death.

Before starting TRINTELLIX, tell your healthcare provider if you have or had liver problems, seizures or convulsions, bipolar disorder (manic depression) or mania, low salt (sodium) levels in your blood, bleeding problems, drink alcohol, have any other medical conditions or if you are pregnant, nursing, plan to become pregnant, or plan to nurse.

TRINTELLIX and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together. Tell your healthcare provider if you plan on or are taking any other prescription and non-prescription medicines, vitamins and herbal supplements including medicines for migraine headaches, such as triptans; medicines used to treat mood, anxiety, psychotic or thought disorders such as tricyclics, lithium, SSRIs, SNRIs, bupropion, buspirone or antipsychotics; MAOIs including linezolid (a specific antibiotic); over-the-counter supplements such as tryptophan or St. John's wort; and the following medicines: aspirin, NSAIDs, warfarin (Coumadin®, Jantoven®), diuretics, rifampin, carbamazepine, phenytoin, quinidine, tramadol or fentanyl.

Common side effects of TRINTELLIX include: nausea, constipation or vomiting. These are not all the possible side effects of TRINTELLIX.

Do not start or stop taking TRINTELLIX without talking to your healthcare provider first. Suddenly stopping TRINTELLIX when you take higher doses may cause you to have side effects including headache, stiff muscles, mood swings, sudden outbursts of anger, dizziness or feeling lightheaded, or runny nose.

Talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication for TRINTELLIX

TRINTELLIX is a prescription medicine used to treat Major Depressive Disorder (MDD) in adults.

Please see Prescribing Information, including Medication Guide for TRINTELLIX.