Trintellix 5mg 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 (vortioxetine) 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.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily 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 this medication, as it can worsen side effects.
- Be aware of the risk of increased suicidal thoughts, especially at the beginning of treatment or after dose changes, and report any concerns to your doctor immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, triptans, or other antidepressants, to avoid serious interactions like serotonin syndrome.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 5 mg orally once daily, titrate to 10 mg once daily. May increase to 20 mg once daily based on tolerability and clinical response. A dose of 5 mg once daily may be considered for patients who cannot tolerate higher doses.
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial 5 mg once daily, target 10-20 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary. Use with caution due to limited data.
Dialysis:
No specific recommendations. Use with caution.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No specific recommendations. Use with caution due to limited data.
Pharmacology
Mechanism of Action
Vortioxetine is a serotonin reuptake inhibitor (SRI) and also acts as an antagonist at 5-HT3, 5-HT7, and 5-HT1D receptors, an agonist at 5-HT1A receptors, and a partial agonist at 5-HT1B receptors. The precise contribution of each of these activities to its antidepressant effect is not fully understood, but it is thought to modulate serotonergic, noradrenergic, dopaminergic, histaminergic, and cholinergic neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
75%
Tmax:
7-11 hours
FoodEffect:
No clinically significant effect on absorption.
Distribution:
Vd:
2600 L
ProteinBinding:
96%
CnssPenetration:
Yes
Elimination:
HalfLife:
66 hours
Clearance:
Not available
ExcretionRoute:
Urine (59%), feces (26%)
Unchanged:
<1% (urine), <2% (feces)
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial antidepressant effects, full effect may take 4-6 weeks.
PeakEffect:
4-6 weeks for maximal antidepressant effect.
DurationOfAction:
Due to long half-life, effects persist for several days after discontinuation.
Safety & Warnings
BLACK BOX WARNING
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 suicidality with antidepressant use in patients over 24; there was a reduction in 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.
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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ 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 cause:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following side effects:
Constipation
Diarrhea
Vomiting
Stomach upset
Dry mouth
Dizziness
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
You can 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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that get bigger
+ Uncontrollable bleeding
Trouble sleeping
Severe dizziness or fainting
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ 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 cause:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following side effects:
Constipation
Diarrhea
Vomiting
Stomach upset
Dry mouth
Dizziness
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
You can 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:
- Signs of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, muscle stiffness, nausea, vomiting, diarrhea.
- Unusual bleeding or bruising.
- New or worsening anxiety, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, restlessness, or mania/hypomania.
- Seizures.
- Eye pain, changes in vision, or swelling/redness around the eye (may indicate angle-closure glaucoma).
- Symptoms of low sodium (hyponatremia): headache, confusion, weakness, unsteadiness.
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 increase the risk of 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
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
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 increase the risk of 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
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
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 discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing side effects. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.
Prior to consuming alcohol, marijuana, or other forms of cannabis, 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 increased 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, may 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 sodium-free diet, consult your doctor to ensure safe use of this medication.
To avoid medication errors, always verify that you have the correct medication, as some medications may have similar appearances or names. If you notice any changes in the medication's shape, color, size, or packaging, 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 may increase the risk of bleeding after delivery and may cause health problems in the newborn. If you are breastfeeding, your doctor will help you weigh the potential risks to your baby.
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 discontinue this medication without first consulting your doctor, as this may increase your risk of experiencing side effects. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.
Prior to consuming alcohol, marijuana, or other forms of cannabis, 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 increased 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, may 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 sodium-free diet, consult your doctor to ensure safe use of this medication.
To avoid medication errors, always verify that you have the correct medication, as some medications may have similar appearances or names. If you notice any changes in the medication's shape, color, size, or packaging, 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 may increase the risk of bleeding after delivery and may cause health problems in the newborn. If you are breastfeeding, your doctor will help you weigh the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Diarrhea
- Abdominal discomfort
- Pruritus
- Somnolence
- Dizziness
- Flushing
- Bradycardia
- Seizures (rare at therapeutic doses, but possible in overdose)
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Management should include treatment of clinical symptoms and monitoring of vital signs. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI, or starting MAOI within 21 days of stopping vortioxetine)
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding.
- Strong CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine, quinidine) - may require vortioxetine dose reduction (e.g., from 10 mg to 5 mg).
Moderate Interactions
- Strong CYP inducers (e.g., rifampin, carbamazepine, phenytoin) - may require vortioxetine dose increase (e.g., from 10 mg to 20 mg).
Monitoring
Baseline Monitoring
Depression severity (e.g., HAM-D, MADRS score)
Rationale: To establish baseline and monitor treatment efficacy.
Timing: Prior to initiation.
Suicidal ideation/behavior
Rationale: Risk of suicidality, especially in young adults.
Timing: Prior to initiation.
Medical history (especially bipolar disorder, seizure disorder, bleeding disorders)
Rationale: To identify contraindications or precautions.
Timing: Prior to initiation.
Routine Monitoring
Clinical response and adverse effects
Frequency: Weekly for first few weeks, then periodically.
Target: Improvement in depressive symptoms, tolerable side effects.
Action Threshold: Lack of response or intolerable side effects may warrant dose adjustment or discontinuation.
Emergence or worsening of suicidal thoughts/behavior
Frequency: Especially during initial treatment and dose changes.
Target: Absence of suicidal ideation.
Action Threshold: Immediate clinical assessment and intervention if present.
Signs of serotonin syndrome
Frequency: Monitor, especially with concomitant serotonergic drugs.
Target: Absence of symptoms (agitation, hallucinations, tachycardia, fever, muscle rigidity, nausea, vomiting, diarrhea).
Action Threshold: Discontinue vortioxetine and supportive care if suspected.
Weight
Frequency: Periodically.
Target: Stable weight.
Action Threshold: Significant weight changes may require intervention.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or attempts
- Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, impulsivity, mania/hypomania)
- Serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
- Abnormal bleeding or bruising
- Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, coma)
- Visual disturbances (e.g., eye pain, changes in vision, swelling or redness in or around the eye)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of vortioxetine in pregnant women. Data from published epidemiologic studies and postmarketing reports are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Consider the potential risks and benefits. Neonates exposed to antidepressants in late third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Trimester-Specific Risks:
First Trimester:
Insufficient data to establish risk.
Second Trimester:
Insufficient data to establish risk.
Third Trimester:
Potential for neonatal complications (e.g., respiratory distress, feeding difficulties, persistent pulmonary hypertension of the newborn (PPHN)).
Lactation
There are no data on the presence of vortioxetine in human milk, the effects on the breastfed infant, or the effects 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.
Infant Risk:
Insufficient data to determine risk. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Trintellix is not approved for use in pediatric patients. A black box warning regarding increased risk of suicidal thoughts and behavior applies to children, adolescents, and young adults (up to 24 years of age) taking antidepressants.
Geriatric Use
No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the effects of antidepressants and may have a higher risk of hyponatremia. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Vortioxetine has a unique multimodal mechanism of action, combining SERT inhibition with direct receptor modulation, which may offer benefits beyond traditional SSRIs/SNRIs for some patients.
- Due to its long half-life (66 hours), steady-state concentrations are reached in about 2 weeks, and withdrawal symptoms can occur even after gradual discontinuation.
- Dose adjustments are necessary when co-administered with strong CYP2D6 inhibitors (decrease vortioxetine dose) or strong CYP inducers (increase vortioxetine dose).
- Monitor for serotonin syndrome, especially when combined with other serotonergic agents.
- Patients should be advised about the potential for increased bleeding risk, particularly if taking anticoagulants or antiplatelets.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., duloxetine, venlafaxine, desvenlafaxine
- Atypical antidepressants e.g., bupropion, mirtazapine
- Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline
- Monoamine Oxidase Inhibitors (MAOIs) e.g., phenelzine, tranylcypromine (reserved for refractory cases)
Cost & Coverage
Average Cost:
Check current market price per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (Specialty)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.