What is TRINTELLIX
(vortioxetine)?
TRINTELLIX is a prescription medicine used in adults to treat a certain
type of depression called Major Depressive Disorder (MDD). TRINTELLIX
has not been shown to be safe and effective for use in
children.
IMPORTANT SAFETY
INFORMATION
Suicidal Thoughts &
Actions
TRINTELLIX and other antidepressants increase the risk of suicidal
thoughts and actions in 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. 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, or if you develop suicidal
thoughts or actions. Call your doctor or get emergency help right away
to report any of these, or 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.
Please see additional Important Safety
Information below.
Savings Offer Eligibility Requirements, Terms & Conditions, and Pharmacy Instructions
Savings Offer Eligibility
Requirements
This offer cannot be used if you are a beneficiary of, or any part of
your prescription is covered by: (1) any federal, state, or
government-funded healthcare program (for example, Medicare, Medicaid,
TRICARE), including a state pharmaceutical assistance program (the
Federal Employees Health Benefits [FEHB] Program is not a
government-funded healthcare program for purposes of this offer), (2)
the Medicare Prescription Drug Program (Part D), or if you are currently
in the coverage gap, or (3) insurance that is paying the entire cost of
the prescription. Patient must be age 18 or older and have a valid
prescription for TRINTELLIX (vortioxetine). Cash patients are not
eligible for this offer.
Savings Offer Terms &
Conditions
You must meet the Eligibility Requirements and report your use of this
offer to any third party that reimburses or pays for any part of the
prescription cost. By using this offer you confirm you are permitted to
use copay coupons under the terms of the benefit plan(s) covering your
prescriptions. You agree not to submit any part of the prescription cost
to a government healthcare program. A valid Prescriber ID# is required
on the prescription. Offer is valid for 13 uses per calendar year until
offer ends. 30-day, 60-day, and 90-day prescriptions count as 1, 2, and
3 uses, respectively. Patients pay at least $10 and receive up to $100,
$200, or $300 off their out-of-pocket cost for a 30-day, 60-day, or
90-day prescription, respectively, with maximum total savings of $1,300
per year. If patient’s insurance rejects the claim, patient pays
at least $75 and receives up to $450 off their out-of-pocket cost for a
30-day prescription, with maximum total savings of $5,850 per year.
Patient pays first $10 or $75, as applicable, plus any cost in excess of
the maximum savings amount per prescription listed above. This offer:
does not constitute insurance; is not valid with any other discount or
program for TRINTELLIX (vortioxetine); may be rescinded, revoked, or
amended at any time without notice; and is void where prohibited by law.
No reproductions. Limit one offer per person. Notify your provider and
pharmacist of any change in your insurance. For questions about this
offer, call 1-866-279-0287.
Savings Offer Pharmacy
Instructions
By submitting this offer for reimbursement to McKesson, you certify
that: (1) you have dispensed TRINTELLIX to an eligible patient in
accordance with the Eligibility Requirements of this offer and the
accompanying prescription; (2) you have not submitted and will not
submit a claim for reimbursement for the portion of the prescription
covered by this offer to any payor; (3) your participation in this
program is consistent with all applicable laws and any obligations,
contractual or otherwise, that you may have as a pharmacy
provider.
SMS and Notifications Terms & Conditions
By opting in to text messages and push notifications from the tAccess Support Program (the “Program”), you consent to receiving approximately 10 text messages and/or push notifications per month from EngagedMedia using autodialer technology. Consent is not a condition of purchase. Such messages may be marketing or non-marketing messages and may include, for example, patient education information, surveys, prescription reminders, and prescription savings opportunities. Carriers are NOT liable for delayed or undelivered messages.
To stop receiving text messages, text STOP to 36395 or the short code from which you received a message. DOING SO WILL ONLY OPT YOU OUT OF TEXT MESSAGES FROM THE PROGRAM; you will remain opted in to any other Takeda text message program(s) to which you separately opted in. If receiving Program push notifications, you may unsubscribe at any time by going into the digital wallet on your device and disabling push notifications in the digital wallet Program pass or by removing the digital wallet Program pass from your device.
To request more information or to obtain help, text HELP to 36395 or the short code from which you received a Program text message. You can also call customer service at 1-866-279-0287.
By opting in to text messages from the Program, you agree to sharing your phone number with EngagedMedia for the purpose of enrolling you into Program text messages.
You represent that you are the account holder for the mobile telephone number(s) that you provide to opt in to text messages from the Program. You are responsible for notifying Takeda immediately if you change your mobile telephone number. You may notify Takeda of a number change by re-opting into Program text messages.
Message and data rates may apply to each text message sent or received in connection with the Program, as provided in your mobile telephone service rate plan, in addition to any applicable roaming charges. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Takeda does not impose a separate fee for sending text messages.
Data obtained from you in connection with the Program may include your telephone number; your carrier's name; the date, time, and content of your text messages; and device information. This data may be used to administer the Program. Please read Takeda’s Privacy Notice, which is incorporated by reference into these Terms and Conditions.
In addition to the data use practices described in the Privacy Notice, Takeda may send you Program-related push notifications. Your device’s location will not be known or tracked by Takeda or its service providers or co-promotion partners. Nonetheless, you may opt out of geofencing and receiving these notifications at any time by (1) disabling location services for your digital wallet app in your device’s settings, (2) disabling notifications (i.e., automatic updates) within the digital wallet app, or (3) removing the tAccess Savings Card from your digital wallet by selecting “Remove Pass” within the digital wallet app.
Neither Takeda nor EngagedMedia will be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.
This service is available only on US participating mobile carriers.
You agree to indemnify Takeda and EngagedMedia in full for all claims, expenses, and damages related to or caused in whole or in part by your failure to notify us if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.
NO CLASS ACTIONS: you may only bring individual claims. Under no circumstance are you allowed to bring a claim as a punitive or named plaintiff or a class member in a class. Class action lawsuits, class-wide arbitrations, private attorney-general actions, and any other proceedings where someone acts in a representative capacity are not allowed. Any combining of individual proceedings must have the consent of all parties.
Takeda may suspend or terminate your receipt of text messages if it believes you are in breach of these Terms and Conditions. Your receipt of text messages is also subject to termination in the event that your mobile telephone service terminates or lapses. Takeda reserves the right to modify or discontinue, temporarily or permanently, all or any part of the text messaging services you receive, with or without notice.
Takeda may revise, modify, or amend these Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to the TRINTELLIX website and digital wallet Program pass. You agree to review these Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.
Takeda may be required to contact you if you report an adverse event or product quality complaint.
Takeda reserves the right to rescind, revoke, or amend the Program without notice at any time.
While Takeda makes reasonable efforts to include accurate, up-to-date information in the Program, Takeda makes no representations or warranties as to its accuracy. Takeda assumes no liability for any errors or omissions in the information communicated through the Program, and such information is not intended to make a diagnosis or to take the place of talking to a US healthcare professional.
IMPORTANT SAFETY INFORMATION
(continued)
Who should not take
TRINTELLIX?
Do not start or take TRINTELLIX if you:
are allergic to vortioxetine or any of the ingredients in TRINTELLIX
are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue
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:
about all your medical and other health conditions
if you are pregnant or plan to become pregnant, since TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester may cause your baby to have withdrawal symptoms after birth or to be at increased risk for a serious lung problem at birth. Tell your doctor right away if you become or think you are pregnant while taking TRINTELLIX
if you are breastfeeding or plan to breastfeed, since it is not known if TRINTELLIX passes into your breast milk
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; lithium; tramadol, fentanyl, meperidine, methadone, or other opioids; tryptophan; buspirone; St. John’s Wort; medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin; diuretics; medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs); or medicines used to treat seizures or convulsions.
What are the possible side effects of
TRINTELLIX?
TRINTELLIX may cause serious side effects, including:
Serotonin syndrome: A potentially life-threatening problem that can happen when you take TRINTELLIX with certain other medicines. Call your doctor or go to the nearest emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: agitation; seeing or hearing things that are not real; confusion; coma; fast heart-beat; changes in blood pressure; dizziness; sweating; flushing; high body temperature; shaking, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting, diarrhea.
Increased risk of bleeding: Taking TRINTELLIX with aspirin, NSAIDs, warfarin or blood thinners may add to this risk. Tell your doctor right away about any unusual bleeding or bruising.
Manic episodes: Manic episodes may happen in people with bipolar disorder who take TRINTELLIX. Symptoms may include: greatly increased energy; racing thoughts; unusually grand ideas; talking more or faster than usual; severe problems sleeping; reckless behavior; excessive happiness or irritability.
Discontinuation syndrome: Suddenly stopping TRINTELLIX may cause you to have serious side effects including: nausea; sweating; changes in your mood; irritability and agitation; dizziness; electric shock feeling; tremor; anxiety; confusion; headache; tiredness; problems sleeping; hypomania; ringing in your ears; seizures.
Eye problems: TRINTELLIX may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your doctor if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
Low levels of salt (sodium) in your blood: Low sodium levels in your blood that may be serious and may cause death can happen during treatment with TRINTELLIX. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in their blood. Signs and symptoms may include headache; difficulty concentrating; memory changes; confusion; weakness and unsteadiness on your feet which can lead to falls. In more severe or more sudden cases, signs and symptoms include: seeing or hearing things that are not real; fainting; seizures; coma; stopping breathing.
Sexual problems: Taking TRINTELLIX may cause sexual problems. Symptoms in males may include: delayed ejaculation or inability to have an ejaculation, decreased sex drive, or problems getting or keeping an erection. Symptoms in females may include: decreased sex drive, or delayed orgasm or inability to have an orgasm. Talk to your doctor if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX.
The most common side effects of TRINTELLIX include:
nausea
constipation
vomiting
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.
For additional Important Safety Information, click here for Medication Guide, and discuss with your doctor.
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. ©2023 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. 1-877-TAKEDA-7 (1-877-825-3327).
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