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How does TRINTELLIX®
(vortioxetine) work?
Patient portrayal.
Individual results may vary.
TRINTELLIX® (vortioxetine) 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.
Serotonin plays a role in Major Depressive Disorder (MDD).
A special mix of chemicals in our brains control how we feel, how we think, and how our bodies work. These chemicals, called neurotransmitters, send messages from one brain cell to another by acting at specific receptors. When these chemicals get out of balance, experts believe it can lead to MDD.
Serotonin is one of those chemicals.
How is TRINTELLIX believed to work?
How TRINTELLIX works is not fully understood, but is thought to be related to its effects on serotonin in two ways:
STOPS SEROTONIN
REUPTAKE
TRINTELLIX helps keep serotonin where it can have an effect
AFFECTS
5 SEROTONIN RECEPTORS
Activity at these receptors could help balance the activity of serotonin
TRINTELLIX is the first and only antidepressant with this specific combination of activities in the brain. It is not known whether this contributes to the antidepressant effect of TRINTELLIX.
Frequently Asked Questions
TRINTELLIX may cause serious side effects, including:
- See the “What is the most important information I should know about TRINTELLIX?” FAQ by following the link below.
- Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take TRINTELLIX with certain other medicines. See the “Who should not take TRINTELLIX?” FAQ by following the link below. Call your healthcare provider or go to the nearest hospital 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 (hallucinations)
- confusion
- coma
- fast heart-beat
- changes in blood pressure
- dizziness
- sweating
- flushing
- high body temperature (hyperthermia)
- shaking (tremors), stiff muscles, or muscle twitching
- loss of coordination
- seizures
- nausea, vomiting, diarrhea
- Increased risk of bleeding. Taking TRINTELLIX with aspirin, non‑steroidal anti‑inflammatory drugs (NSAIDs), warfarin or blood thinners may add to this risk. Tell your healthcare provider 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 episodes. Suddenly stopping TRINTELLIX may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
- nausea
- sweating
- changes in your mood
- irritability and agitation
- dizziness
- electric shock feeling (paresthesia)
- tremor
- anxiety
- confusion
- headache
- tiredness
- problems sleeping
- hypomania
- ringing in your ears (tinnitus)
- seizures
- Eye problems (angle-closure glaucoma). 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 healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
- Low levels of sodium in your blood (hyponatremia). 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 your 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 (hallucinations)
- fainting
- seizures
- coma
- stopping breathing (respiratory arrest)
- Sexual problems (dysfunction). Taking TRINTELLIX may cause sexual problems.
Symptoms in males may include:
- delayed ejaculation or inability to have an ejaculation
- problems getting or keeping an erection
- decreased sex drive
Symptoms in females may include:
- decreased sex drive
- delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX. There may be treatments your healthcare provider can suggest.
The most common side effects of TRINTELLIX include nausea, constipation, and vomiting.
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.
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, or buspirone
- opioids (such as fentanyl, tramadol, meperidine, and methadone)
- over-the-counter supplements such as tryptophan or St. John’s Wort
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- aspirin
- warfarin
- diuretics
- medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
- medicines used to treat seizures or convulsions
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, see the “What are the possible side effects of TRINTELLIX?” FAQ above. Know the medicines you take. Keep a list of them to show your healthcare professional or pharmacist when you get new medicine.
Selective serotonin re-uptake inhibitors (SSRIs) are a common type of antidepressant used to treat Major Depressive Disorder (MDD) by enhancing the activity of serotonin in specific pathways of the brain.
The mechanism of the antidepressant effect of TRINTELLIX is not fully understood. However, the antidepressant effect of both TRINTELLIX and SSRIs is thought to be related to their enhancement of serotonin activity in the central nervous system. Experts believe that 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. The function and effect of TRINTELLIX is believed to be related to the inhibition of serotonin reuptake. In addition, TRINTELLIX blocks the activities of certain receptors while enhancing that of others. The contribution of these functions to TRINTELLIX's antidepressant effect has not been established.
