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Indication: TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.

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Takeda Website Terms and Conditions of Use

These Terms and Conditions of Use constitute the entire agreement between you and Takeda Pharmaceuticals U.S.A., Inc. (formerly Takeda Pharmaceuticals North America, Inc.) and its parent companies, subsidiaries, and affiliates (collectively, "Takeda"), relating to the information on, and your use of, the Websites at which these Terms and Conditions of Use are posted (collectively, the "Websites"). By using our Websites, you are acknowledging your consent to these Terms and Conditions of Use. Do not use our Websites if you do not agree to the following Terms and Conditions of Use. Takeda reserves the right to modify these Terms and Conditions of Use from time to time. These Terms and Conditions of Use should be read in conjunction with our online Privacy Policy.

Notwithstanding anything to the contrary in the foregoing, you may be subject to certain additional agreements with Takeda in addition to these Terms and Conditions of Use, which agreements may impact your ability to use our Websites. In the event that such agreements impose additional obligations on you not described in these Terms and Conditions of Use, those additional obligations will be considered to be a part of these Terms and Conditions of Use.

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If any of the above exclusions of warranties is unenforceable in your jurisdiction, the other exclusions listed above will still be given effect to the full extent permitted by that jurisdiction's law. 

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THE INFORMATION ON OUR WEBSITES MAY CONTAIN INACCURACIES OR TYPOGRAPHICAL ERRORS. TAKEDA RESERVES THE RIGHT TO MAKE ADDITIONS, DELETIONS, OR MODIFICATIONS TO THE INFORMATION ON ANY OF OUR WEBSITES AT ANY TIME WITHOUT PRIOR NOTICE. TAKEDA ALSO RESERVES THE RIGHT TO WITHDRAW ANY OF OUR WEBSITES OR ANY INFORMATION CONTAINED ON OUR WEBSITES FROM THE INTERNET AT ANY TIME WITHOUT PRIOR NOTICE. ANYONE USING ANY OF OUR WEBSITES OR THE INFORMATION THEY CONTAIN ASSUMES FULL RESPONSIBILITY OF ANY AND ALL RISKS ARISING FROM OR RELATED TO THE USE OF SUCH WEBSITES OR THE INFORMATION THEY CONTAIN.

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If any visitor of our Websites makes any voluntary submission (such as questions, comments, or suggestions) to Takeda, whether oral, written, or electronic, no confidential relationship shall be established between the visitor and Takeda. The visitor's submission, and any information submitted with it, shall be considered non-confidential and shall be considered the sole and exclusive property of Takeda. You agree that such submission constitutes a "work for hire," under U.S. copyright law. You agree to assign all rights in and to your submission to Takeda. Takeda shall have no obligation of any kind (such as compensation) with respect to the submission or any materials that accompany it. Takeda shall be free to use or transmit to others any ideas, concepts, information, or techniques contained in the visitor's submission and accompanying materials for any purpose whatsoever, including but not limited to research, development, manufacture, use, or sale of any products or ingredients incorporating or relying on such information. 

Note: A visitor's personal information is treated in accordance with our online Privacy Policy.

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Should you become employed with Takeda, none of the information or materials on any of our Websites shall constitute or be considered part of an employment contract or an employee manual or handbook. Nothing stated or represented on any of our Websites shall affect the employment relationships between Takeda and its current, former, or future employees.

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Severability

In the event that any provision of these Terms and Conditions of Use shall, in whole or in part, be determined to be invalid, unenforceable, or void for any reason, the remainder of these Terms and Conditions of Use shall not be affected in any way thereby.

Conditions of Use, Notices and Changes to the Privacy Policy

From time to time, our internal processes may change, or we may offer new or altered features at our Websites. If appropriate, we will revise these Terms and Conditions of Use or our Privacy Policy. We reserve the right, to the fullest extent permitted by law, to amend either these Terms and Conditions of Use or our Privacy Policy at any time without notice to you other than the posting of an amended Terms and Conditions of Use or Privacy Policy at our Websites. We encourage you to return to this area to read the most recent version of our Terms and Conditions of Use and Privacy Policy. The personal information you provide on our Websites will be treated in compliance with the Privacy Policy in effect as of the date you provide your personal information to us. However, if we alter our practices in a manner that will affect the treatment of the personal information you have already provided, we will attempt to provide visitors who have registered on our Websites with notice of our new Privacy Policy via e-mail.

Effective Date

This Terms and Conditions of Use is effective as of March 5, 2012.

 

Important Safety Information for TRINTELLIX (vortioxetine)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

TRINTELLIX has not been evaluated for use in pediatric patients.

CONTRAINDICATIONS

Hypersensitivity: Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation. Angioedema has been reported in patients treated with TRINTELLIX.

Monoamine Oxidase Inhibitors (MAOIs): Due to an increased risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. Do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue.

WARNINGS AND PRECAUTIONS

Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania), especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients daily.

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants (SNRIs, SSRIs, and others), including TRINTELLIX, when used alone but more often when used concomitantly with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If such symptoms occur, discontinue TRINTELLIX and any concomitant serotonergic agents, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX is clinically warranted, patients should be made aware of and monitored for potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Abnormal Bleeding: Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation.

Activation of Mania/Hypomania: Activation of mania/hypomania can occur with antidepressant treatment. Prior to initiating treatment with an antidepressant, screen patients for bipolar disorder. As with all antidepressants, use TRINTELLIX cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including TRINTELLIX, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia: Hyponatremia has occurred as a result of serotonergic drugs and in many cases, appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and patients taking diuretics or who are otherwise volume-depleted can be at greater risk. More severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and initiate appropriate medical intervention.

Adverse Reactions: The most commonly observed adverse reactions for TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were by dose (5 mg, 10 mg, 15 mg, 20 mg) vs placebo: nausea (21%, 26%, 32%, 32% vs 9%), constipation (3%, 5%, 6%, 6% vs 3%), and vomiting (3%, 5%, 6%, 6% vs 1%).

Drug Interactions: Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.

Indication

TRINTELLIX is indicated for the treatment of major depressive disorder in adults.

Please see Full Prescribing Information and Medication Guide for TRINTELLIX.

References

  • 1. Conradi HJ, Ormel J, de Jonge P. Presence of individual (residual) symptoms during depressive episodes and period of remission: a 3-year prospective study. Psychol Med. 2011;41(6):1165-1174.
  • 2. American Psychiatric Association. Depressive disorders. In: Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed. Arlington, VA: American Psychiatric Association; 2013:155-188.
  • 3. Trintellix (vortioxetine) prescribing information. Takeda Pharmaceuticals.
  • 4. Alvarez E, Perez V, Dragheim M, et al. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
  • 5. Henigsberg N, Mahableshwarkar AR, Jacobsen P, et al. 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.
  • 6. 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.
  • 7. Mahableshwarkar AR, Jacobsen PL, Chen Y, et al. 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.
  • 8. Data on file. Takeda Pharmaceuticals.
  • 9. Jacobsen PL, Mahableshwarkar AR, Serenko M, et al. 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.
  • 10. 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.
  • 11. 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.
  • 12. Gelenberg AJ, Freeman MP, Markowitz JC, et al, for the Work Group on Major Depressive Disorder. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 3rd ed. Arlington, VA: American Psychiatric Publishing; 2010.
  • 13. Werner F, Coveñas R. Classical neurotransmitters and neuropeptides involved in major depression in a multi-neurotransmitter system: a focus on antidepressant drugs. Curr Med Chem. 2013;20(38):
    4853-4858
    .
  • 14. Baldwin DS, Chrones L, Florea I, et al. The safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies. J Psychopharmacol. 2016;30(3):242-252.
Important Safety Information
Important Safety Information

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

TRINTELLIX has not been evaluated for use in pediatric patients.

CONTRAINDICATIONS

Hypersensitivity: Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation. Angioedema has been reported in patients treated with TRINTELLIX.

Monoamine Oxidase Inhibitors (MAOIs): Due to an increased risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. Do not start TRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue.

WARNINGS AND PRECAUTIONS

Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania), especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients daily.

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants (SNRIs, SSRIs, and others), including TRINTELLIX, when used alone but more often when used concomitantly with other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If such symptoms occur, discontinue TRINTELLIX and any concomitant serotonergic agents, and initiate supportive symptomatic treatment. If concomitant use of TRINTELLIX is clinically warranted, patients should be made aware of and monitored for potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Abnormal Bleeding: Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when TRINTELLIX is coadministered with NSAIDs, aspirin, or other drugs that affect coagulation.

Activation of Mania/Hypomania: Activation of mania/hypomania can occur with antidepressant treatment. Prior to initiating treatment with an antidepressant, screen patients for bipolar disorder. As with all antidepressants, use TRINTELLIX cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including TRINTELLIX, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia: Hyponatremia has occurred as a result of serotonergic drugs and in many cases, appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Elderly patients and patients taking diuretics or who are otherwise volume-depleted can be at greater risk. More severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Discontinue TRINTELLIX in patients with symptomatic hyponatremia and initiate appropriate medical intervention.

Adverse Reactions: The most commonly observed adverse reactions for TRINTELLIX in 6- to 8-week placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were by dose (5 mg, 10 mg, 15 mg, 20 mg) vs placebo: nausea (21%, 26%, 32%, 32% vs 9%), constipation (3%, 5%, 6%, 6% vs 3%), and vomiting (3%, 5%, 6%, 6% vs 1%).

Drug Interactions: Concomitant administration of TRINTELLIX and strong CYP2D6 inhibitors or strong CYP inducers may require a dose adjustment of TRINTELLIX.

Indication

TRINTELLIX is indicated for the treatment of major depressive disorder in adults.

Please see Full Prescribing Information and Medication Guide for TRINTELLIX.