What is the most important information I should know about TRINTELLIX?

• Increased risk of suicidal thoughts and actions. TRINTELLIX and other antidepressant medicines may increase suicidal thoughts and actions in some 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.
  How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

• are allergic to vortioxetine or any of the ingredients in TRINTELLIX. See the end of this Medication Guide for a complete list of ingredients in TRINTELLIX
• take a Monoamine Oxidase Inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue

• have or had seizures or convulsions
• have or had bleeding problems
• have, or have a family history of, bipolar disorder, mania or hypomania
• have high pressure in the eye (glaucoma)
• have low sodium levels in your blood
• are pregnant or plan to become pregnant. TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester of pregnancy may cause your baby to have withdrawal symptoms after birth or may cause your baby to be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risks to you and your unborn or newborn baby if you take TRINTELLIX during pregnancy.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with TRINTELLIX.
  • There is a pregnancy registry for females who are exposed to TRINTELLIX during pregnancy. The purpose of the registry is to collect information about the health of females exposed to TRINTELLIX and their baby. If you become pregnant during treatment with TRINTELLIX, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
• are breastfeeding or plan to breastfeed. It is not known if TRINTELLIX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TRINTELLIX.

• medicines used to treat migraine headache called triptans
• tricyclic antidepressants
• fentanyl
• lithium
• tramadol
• tryptophan
• buspirone
• St. John's Wort
• medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
• diuretics

What are the possible side effects of TRINTELLIX?

• See , " What is the most important information I should know about TRINTELLIX?"
• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take TRINTELLIX with certain other medicines. See, "Who should not take TRINTELLIX?" 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:

• 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:

• severe problems sleeping
• reckless behavior
• excessive happiness or irritability

• Discontinuation syndrome. Suddenly stopping TRINTELLIX may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:

• 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
  • Decreased sex drive
  • Problems getting or keeping an erection
  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.