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Experts believe that Major Depressive Disorder (MDD) results when certain chemicals in the brain are out of balance. These chemicals, called neurotransmitters, send messages from one brain cell to another by acting at specific receptors.
Although it's not fully understood, TRINTELLIX is thought to work by enhancing the activity of a neurotransmitter called serotonin in the brain by blocking serotonin reuptake.
It also has activities on some of the receptors for this brain chemical. The link between this information and therapeutic benefit is not known.
Superscript: When you think of life with Major Depressive Disorder, or MDD, what do you see?
Voice over: When you think of life with Major Depressive Disorder, or MDD, what do you see? People may think they know exactly what MDD looks like. But the truth is that MDD looks different for everyone because everyone experiences it differently. To get a more authentic picture of MDD, we have to look at not just the disorder, but also some people living with it. Because when a patient works with their doctor to find the treatment plan that’s right for them, it may have a noticeable impact on their MDD. That’s what I want other patients to know.
Superscript: Who am I?
Voice over: Who am I?
Superscript: A real patient with MDD.
Voice over: My name is Jesus.
Voice over: My name is Ruth.
Voice over: Hi, I am Tatiana.
Superscript: What is TRINTELLIX? TRINTELLIX (vortioxetine) is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD). By prescription only.
Voice over: Our doctors told us about TRINTELLIX, a prescription medicine for adults with a type of depression called Major Depressive Disorder, or MDD.
Superscript: TRINTELLIX + STORYTELLERS = TRINTELLERS are real MDD patients treated with TRINTELLIX who are here to share their stories with others.
Voice over: Now—We’ve become the first TRINTELLERS, a collection of actual TRINTELLIX patients who are telling personal stories of our lives with MDD. Each of us will be recording one second of our lives everyday, as well as telling you about our recent experiences with MDD, working with our doctors, and our journey with TRINTELLIX.
Superscript: TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger. TRINTELLIX is not approved for children under 18.
Voice over: Antidepressants, like TRINTELLIX, may increase suicidal thoughts and actions in some people 24 years of age and younger.
Superscript: Call your doctor or get emergency help right away if you have new or worsening depression symptoms, new or sudden changes in mood, behavior, thoughts or feelings, or suicidal thoughts or actions.
Voice over: Call your doctor right away if you have new or worsening depression symptoms, unusual changes in mood, behavior or thoughts, or suicidal thoughts or actions while taking it.
Superscript: Do not take it if you take MAOIs, or if you are allergic to vortioxetine or any other ingredients in TRINTELLIX.
Voice over: Do not take it if you take MAOIs, or if you are allergic to vortioxetine or any other ingredients in TRINTELLIX.
Superscript: Tell your doctor about all your medical conditions and all the medicines you take. Taking TRINTELLIX with certain medicines can result in a life-threatening condition.
Voice over: Tell your doctor about all medicines you take, including migraine, psychiatric, and depression medicines, to avoid a potentially life-threatening condition.
Superscript: TRINTELLIX may increase risk of bleeding. Tell your doctor right away about any unusual bleeding or bruising.
Voice over: Increased risk of bleeding and bruising may occur, especially if taken with aspirin, NSAID pain relievers, warfarin, or blood thinners.
Superscript: Call your doctor if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
Voice over: Manic episodes can occur in people with bipolar disorder. Call your doctor if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
Superscript: Suddenly stopping TRINTELLIX may cause you to have serious side effects. Visual problems may occur in some people. TRINTELLIX may cause low sodium levels and sexual problems.
Voice over: Suddenly stopping TRINTELLIX may cause you to have serious side effects. Visual problems may occur in some people. TRINTELLIX may cause low sodium levels and sexual problems.
Superscript: Common side effects of TRINTELLIX include nausea, constipation, and vomiting.
Voice over: Common side effects include nausea, constipation, and vomiting.
Voice over: Although we know there isn’t a cure for MDD and that we’ll continue to face challenges, we want to start the conversation and raise awareness for others who may be living with MDD.
Superscript: Individual results may vary.
Voice over: Together, we hope to encourage other MDD patients to work with their doctor to find the treatment plan that works for them.
Superscript: Medication may not be appropriate for everyone.
Voice over: Thank you and see y’all soon.
Superscript: For more safety information, including Boxed WARNING for Suicidal Thoughts and Actions, please click on the link to Medication Guide located at bottom of this video player and talk to your doctor. 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.
Superscript: 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. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited.
©2021 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. 1-877-TAKEDA-7 (877-825-3327). US-VOR-0821v1.0 11/21
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Suicidal Thoughts and Actions and Antidepressant DrugsAntidepressants 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 TRINTELLIXTake 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 daysTRINTELLIX 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 TRINTELLIXTRINTELLIX is a prescription medicine used to treat Major Depressive Disorder (MDD) in adults.
TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children under 18. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Pay close attention to any changes, especially new or sudden changes in mood, behavior, thoughts, or feelings. Call your doctor or get emergency help right away if you have symptoms such as suicidal thoughts or actions, impulsivity, aggressive or violent actions, depression, anxiety or panic attacks, agitation, restlessness, anger, irritability, trouble sleeping, an increase in activity or talking, or other unusual changes in behavior or mood; especially if they are new, worse, or worry you.
Who should not take TRINTELLIX?
Do not start or take TRINTELLIX if you:
Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX.
What should I tell my doctor before taking TRINTELLIX?
Before taking TRINTELLIX, tell your doctor:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since TRINTELLIX and some medicines may cause serious side effects (or may not work as well) when taken together. Especially tell your doctor if you take: medicines for migraine headache called triptans; tricyclic antidepressants; opioids (such as fentanyl and tramadol); lithium; tryptophan; buspirone; St. John’s Wort; medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin; and diuretics.
What are the possible side effects of TRINTELLIX?
TRINTELLIX may cause serious side effects, including:
The most common side effects of TRINTELLIX include:
These are not all the possible side effects of TRINTELLIX. Tell your doctor if you have any side effect that bothers you or does not go away.
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.
TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD).
There is a pregnancy registry for females who are exposed to antidepressants during pregnancy. The purpose of the registry is to collect information about the health of females exposed to antidepressants and their babies. If you become pregnant during treatment with TRINTELLIX, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
For additional Important Safety Information, click here for Medication Guide, and discuss with your doctor.