Trintellix 20mg Tb (was Brintellix)
WARNING: In some studies, drugs used for depression raised the risk of suicidal thoughts or actions in children and young adults. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.
Drug Class
Antidepressant
Pharmacologic Class
Serotonin Modulator and Stimulator (SMS)
Pregnancy Category
Not available
FDA Approved
Sep 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Trintellix is a medication used to treat depression. It works by affecting certain chemicals in the brain, primarily serotonin, to help improve mood and other symptoms of depression. It's different from some other antidepressants because it affects serotonin in multiple ways.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Trintellix exactly as prescribed by your doctor, usually once a day, with or without food.
- Do not stop taking Trintellix suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking Trintellix, as it may worsen side effects like dizziness or drowsiness.
- Be cautious when driving or operating machinery until you know how Trintellix affects you.
- Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg once daily, may increase to 20 mg once daily
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
initial_dose:
Start with 5 mg once daily for 1 week, then increase to 10 mg once daily.
maintenance_dose:
10 mg to 20 mg once daily, depending on tolerability and efficacy.
poor_metabolizers_CYP2D6:
Consider a maximum dose of 10 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed.
Dialysis:
No specific recommendations; vortioxetine is highly protein bound and unlikely to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not studied; use with caution.
Pharmacology
Mechanism of Action
Vortioxetine is a multimodal antidepressant. Its mechanism of action is thought to be related to its direct modulation of serotonin receptor activity and inhibition of the serotonin (5-HT) transporter (SERT). It acts as an inhibitor of serotonin reuptake, an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors. The combination of these activities is thought to contribute to its antidepressant and anxiolytic effects.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
7-11 hours
FoodEffect:
Food does not affect the Cmax or AUC of vortioxetine.
Distribution:
Vd:
2600 L
ProteinBinding:
98-99%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 66 hours (range 57-73 hours)
Clearance:
Not available
ExcretionRoute:
Approximately 59% in urine and 26% in feces, primarily as inactive metabolites.
Unchanged:
Less than 1% of vortioxetine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial antidepressant effects, full effect may take 4-6 weeks.
PeakEffect:
4-6 weeks
DurationOfAction:
Due to long half-life, effects persist for several days after discontinuation, but withdrawal symptoms can occur if stopped abruptly.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Trintellix or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trintellix is not approved for use in pediatric patients.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm or ejaculation problems
+ Trouble getting or maintaining an erection
Eye problems, such as:
+ Eye pain
+ Changes in vision
+ Swelling or redness in or around the eye
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation or changes in balance
+ Confusion or hallucinations
+ Fever or fast/abnormal heartbeat
+ Flushing or muscle twitching/stiffness
+ Seizures or shivering/shaking
+ Excessive sweating or severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation, diarrhea, vomiting, or stomach upset
Dry mouth
* Dizziness
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm or ejaculation problems
+ Trouble getting or maintaining an erection
Eye problems, such as:
+ Eye pain
+ Changes in vision
+ Swelling or redness in or around the eye
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation or changes in balance
+ Confusion or hallucinations
+ Fever or fast/abnormal heartbeat
+ Flushing or muscle twitching/stiffness
+ Seizures or shivering/shaking
+ Excessive sweating or severe diarrhea, nausea, or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Constipation, diarrhea, vomiting, or stomach upset
Dry mouth
* Dizziness
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worsening depression
- New or worsening anxiety
- Feeling agitated or restless
- Panic attacks
- Trouble sleeping (insomnia)
- New or worsening irritability
- Acting aggressive, being angry, or violent
- An increase in activity and talking (mania)
- Other unusual changes in behavior or mood
- Signs of serotonin syndrome (e.g., agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Unusual bleeding or bruising
- Eye pain, changes in vision, or swelling or redness in or around the eye (angle-closure glaucoma)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue
+ Drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
It is crucial to note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication.
To ensure your safety, it is vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Any existing health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking or have recently taken certain medications, including:
+ Linezolid or methylene blue
+ Drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
It is crucial to note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication.
To ensure your safety, it is vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Any existing health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of experiencing side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
When treating depression, you may notice improvements in sleep and appetite soon after starting this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.
This medication may interfere with certain laboratory tests, so it is crucial to inform your doctor and laboratory personnel that you are taking this medication.
There is a potential risk of bleeding associated with this medication, which can be life-threatening in some cases. Consult your doctor to discuss this risk.
Low blood sodium levels, a condition known as hyponatremia, can occur with this medication. In severe cases, this can be fatal, so it is essential to discuss this risk with your doctor.
If you are following a low-sodium or salt-free diet, consult your doctor to ensure safe use of this medication.
To avoid medication errors, always verify that you have the correct product, as some medications may have similar appearances or names. If you notice any changes in the shape, color, size, or labeling of your medication, consult your pharmacist.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication during pregnancy or breastfeeding. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during this time.
Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of experiencing side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
When treating depression, you may notice improvements in sleep and appetite soon after starting this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.
This medication may interfere with certain laboratory tests, so it is crucial to inform your doctor and laboratory personnel that you are taking this medication.
There is a potential risk of bleeding associated with this medication, which can be life-threatening in some cases. Consult your doctor to discuss this risk.
Low blood sodium levels, a condition known as hyponatremia, can occur with this medication. In severe cases, this can be fatal, so it is essential to discuss this risk with your doctor.
If you are following a low-sodium or salt-free diet, consult your doctor to ensure safe use of this medication.
To avoid medication errors, always verify that you have the correct product, as some medications may have similar appearances or names. If you notice any changes in the shape, color, size, or labeling of your medication, consult your pharmacist.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication during pregnancy or breastfeeding. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during this time.
Overdose Information
Overdose Symptoms:
- Nausea
- Dizziness
- Diarrhea
- Abdominal discomfort
- Generalized pruritus
- Somnolence
- Flushing
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and symptomatic. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of stopping an MAOI, or starting an MAOI within 21 days of stopping vortioxetine.
- Linezolid (reversible non-selective MAOI)
- Methylene blue (reversible non-selective MAOI)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Drugs that impair metabolism of vortioxetine (e.g., strong CYP2D6 inhibitors like bupropion, fluoxetine, paroxetine, quinidine) - may require dose reduction of vortioxetine.
- Drugs that induce metabolism of vortioxetine (e.g., strong CYP inducers like rifampin, carbamazepine, phenytoin) - may require dose increase of vortioxetine.
- Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding.
Moderate Interactions
- Alcohol - may potentiate CNS effects, though specific pharmacokinetic interaction is minimal.
- Other CNS depressants - additive CNS depression.
Monitoring
Baseline Monitoring
Depression severity (e.g., PHQ-9, HAM-D)
Rationale: To establish baseline and monitor treatment response.
Timing: Prior to initiation
Suicidal ideation/behavior assessment
Rationale: To assess baseline risk, especially in young adults and adolescents.
Timing: Prior to initiation
Electrolytes (especially sodium)
Rationale: To assess baseline for hyponatremia risk, particularly in elderly or those on diuretics.
Timing: Prior to initiation, if risk factors present
Bleeding risk assessment
Rationale: To assess baseline risk, especially if on concomitant anticoagulants/antiplatelets.
Timing: Prior to initiation
Routine Monitoring
Clinical worsening of depression, suicidality, or unusual changes in behavior
Frequency: Weekly during initial weeks of therapy, then periodically as clinically indicated.
Target: Improvement or stability
Action Threshold: Immediate clinical evaluation and potential dose adjustment or discontinuation if worsening occurs.
Signs/symptoms of Serotonin Syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Frequency: Ongoing, especially with concomitant serotonergic drugs.
Target: Absence of symptoms
Action Threshold: Discontinue vortioxetine and initiate supportive care if suspected.
Hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness)
Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics.
Target: Sodium within normal limits
Action Threshold: Monitor serum sodium; discontinue vortioxetine if severe hyponatremia develops.
Abnormal bleeding/bruising
Frequency: Ongoing, especially with concomitant anticoagulants/antiplatelets.
Target: Absence of unusual bleeding
Action Threshold: Evaluate cause; consider discontinuation if severe or unexplained bleeding occurs.
Symptoms of mania/hypomania
Frequency: Ongoing, especially in patients with bipolar disorder or risk factors.
Target: Absence of symptoms
Action Threshold: Discontinue vortioxetine if mania/hypomania develops.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Anxiety
- Agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania
- Mania
- Confusion
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dry mouth
- Constipation
- Sexual dysfunction
- Unusual bleeding or bruising
Special Patient Groups
Pregnancy
Limited data on vortioxetine use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Neonates exposed to antidepressants in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show no evidence of teratogenicity.
Second Trimester:
Limited human data.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia) in neonates.
Lactation
Vortioxetine is present in human milk. There are no data on the effects of vortioxetine on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trintellix and any potential adverse effects on the breastfed infant from Trintellix or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.
Infant Risk:
L3 (Moderately safe) - potential for adverse effects, but generally considered compatible with monitoring.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Trintellix is not approved for use in pediatric patients. Antidepressants carry a Black Box Warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults.
Geriatric Use
No dose adjustment is recommended based on age. However, elderly patients may be at increased risk for hyponatremia and bleeding. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Vortioxetine has a unique multimodal mechanism of action, which may offer benefits for cognitive symptoms associated with depression, though more research is needed.
- Due to its long half-life, it takes about 1-2 weeks to reach steady-state concentrations, and withdrawal symptoms can be prolonged if discontinued abruptly.
- The most common side effects are nausea, constipation, and vomiting, which tend to be dose-dependent and often decrease over time.
- Sexual dysfunction rates may be lower compared to some other SSRIs/SNRIs, but it can still occur.
- Patients who are poor CYP2D6 metabolizers may require a lower maximum dose (e.g., 10 mg/day) due to higher drug exposure.
Alternative Therapies
- SSRIs (e.g., escitalopram, sertraline, fluoxetine, citalopram, paroxetine)
- SNRIs (e.g., venlafaxine, duloxetine, desvenlafaxine, levomilnacipran)
- Atypical antidepressants (e.g., bupropion, mirtazapine)
- Tricyclic Antidepressants (TCAs)
- MAOIs (e.g., phenelzine, tranylcypromine, selegiline)
- Other serotonin modulators (e.g., vilazodone)
Cost & Coverage
Average Cost:
$400 - $550 per 30 tablets (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor immediately. It's essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call the poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.