Vortioxetine

Vortioxetine is a prescription medication used to treat Major Depressive Disorder. 

• Vortioxetine is available under the following different brand names: Trintellix.  

Adult dosage

Tablet, immediate-release

• 5mg
• 10mg
• 20mg

Major Depressive Disorder

Adult dosage

• 10 mg orally once daily; dose should then be increased to 20 mg/day, as tolerated
• Considering decreasing dose to 5 mg/day if higher doses are not tolerated
• Efficacy and safety of doses over 20 mg/day have not been evaluated

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Vortioxetine include:

• nausea, 
• constipation, and 
• vomiting

Serious side effects of Vortioxetine include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• mood or behavior changes, 
• anxiety, 
• panic attacks, 
• trouble sleeping, 
• impulsiveness, 
• irritableness, 
• agitation, 
• hostility, 
• aggression, 
• restlessness, 
• hyperactivity (mentally or physically), 
• increased depression, 
• thoughts of self-harm, 
• racing thoughts, 
• decreased need for sleep, 
• unusual risk-taking behavior, 
• feeling extreme happiness or sadness, 
• being more talkative than usual, 
• vision changes, 
• eye pain, 
• eye redness or swelling, 
• easy bruising, 
• unusual bleeding, 
• coughing up blood, 
• confusion, 
• memory problems, 
• hallucinations, 
• slurred speech, 
• severe weakness, 
• feeling unsteady, 
• hallucinations, 
• fever, 
• sweating, 
• shivering, 
• fast heart rate, 
• muscle stiffness, 
• twitching, 
• loss of coordination, 
• nausea, 
• vomiting, and 
• diarrhea 

Rare side effects of Vortioxetine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Vortioxetine has severe interactions with the following drugs:
  • isocarboxazid
  • linezolid
  • methylene blue
  • phenelzine
  • rasagiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Vortioxetine has serious interactions with at least 79 other drugs.
• Vortioxetine has moderate interactions with at least 104 other drugs.
• Vortioxetine has minor interactions with the following drug:
  • ribociclib  

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to vortioxetine or any component of formulation.
• MAOI
• Use of MAOIs (intended to treat psychiatric disorders) or within 21 days of discontinuing with vortioxetine
• Use of vortioxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders
• Currently being treated with another MAOI (eg, linezolid, IV methylene blue)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vortioxetine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vortioxetine?”

Cautions

• May worsen mania symptoms or activate mania/hypomania in patients with bipolar disorder
• Risk of mydriasis; may trigger angle closure attack in patients with angle-closure glaucoma with anatomically narrow angles without a patent iridectomy
• Increases risk of hyponatremia and cognitive impairment especially in the elderly; hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH); patients taking diuretics or who are otherwise volume-depleted can be at greater risk; consider discontinuation of drug in patients with symptomatic hyponatremia; appropriate medical intervention should be instituted
• Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers because these patients have higher vortioxetine plasma concentrations than extensive CYP2D6 metabolizers
• Suicidal thoughts and behaviors in adolescents and young adults
  • In pooled studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (younger than 24 years) taking antidepressants for MDD and other psychiatric illnesses
  • Variations in risk of suicidal thoughts and behaviors among drugs and across the different indications, highest incidence in patients with MDD
  • Unknown if risk extends to longer-term use
  • Closely monitor for behavioral changes, clinical worsening, and suicidal tendencies during initial 1-2 months of therapy and dosage adjustments
  • Counsel family members or caregivers to monitor for changes in behavior and to alert the healthcare provider; consider changing the therapeutic regimen, including possibly discontinuing therapy, in patients whose depression is persistently worse, or who are experiencing emergent of suicidal thoughts and behaviors
• Serotonin syndrome
  • Serotonin syndrome reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with vortioxetine, both when taken alone, but especially when coadministered with other serotonergic agents (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort)
  • Symptoms include mental status changes, autonomic instability, neuromuscular symptoms, seizures, and/or gastrointestinal symptoms
  • If symptoms occur, discontinue therapy and initiate supportive treatment
  • If concomitant use with other serotonergic drugs is clinically warranted, advise of potential risks for serotonin syndrome, particularly during treatment initiation and dose increases
• Discontinuation syndrome
  • Adverse reactions reported upon abrupt discontinuation of treatment at doses of 15-20 mg/day
  • Gradual reduction in dosage is recommended whenever possible
  • Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances, tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures
• Sexual dysfunction
  • Use may cause symptoms of sexual dysfunction in both male and female patients; inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider
  • Use of SSRIs, may cause symptoms of sexual dysfunction; in male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction
  • In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm
  • Important for prescribers to inquire about sexual function prior to initiation of therapy and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported
  • When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including underlying psychiatric disorder
  • Discuss potential management strategies to support patients in making informed decisions about treatment
• Drug interaction overview
• Substrate of CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8 and CYP2B6
• Increase of serotonin syndrome
  • Contraindicated with MAOIs
  • Coadministration with serotonergic drugs increases the risk of serotonin syndrome
  • Monitor; if serotonin syndrome occurs, consider discontinuing vortioxetine
• Strong CYP2D6 inhibitor
  • Coadministration with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine
• Strong CYP inducers
  • Coadministration with strong CYP2D6 inhibitors decreases plasma concentrations of vortioxetine
• Drugs that interfere coagulation or bleeding
  • Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase risk of abnormal bleeding
  • Exercise caution with concomitant use of vortioxetine with nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or other drugs that affect coagulation
  • Monitor INR when used with warfarin
• Drugs highly bound to plasma protein
  • Coadministration of vortioxetine with drugs highly bound to plasma protein (e.g.,, warfarin) may increase free concentrations of vortioxetine or other highly bound drugs in plasma
  • Monitor for adverse reactions and reduce dosage of both protein bound drugs as needed

Pregnancy and Lactation

• Limited human data available on use during pregnancy to inform any drug-associated risks. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1- 844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/
• Women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum
• Exposure to serotonergic antidepressants, including vortioxetine, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN); monitor neonates who were exposed to drug in the third trimester of pregnancy for PPHN and drug discontinuation syndrome
• There is no information regarding presence of vortioxetine in human milk, effects on the breastfed infant, or effects on milk production
• Present in rat milk
• Consider developmental and health benefits of breastfeeding along with mother's clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition