Vortioxetine Tablets

What is this medication?

Vortioxetine (vor tee OX e teen) treats depression. It increases the amount of serotonin in the brain, a substance that helps regulate mood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BRINTELLIX, Trintellix

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder or a family history of bipolar disorder
• Bleeding disorder
• Glaucoma
• Liver disease
• Low levels of sodium in the blood
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• Take medications that treat or prevent blood clots
• Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to vortioxetine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Linezolid
• MAOIs, such as Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)

This medication may also interact with the following:

• Aspirin and aspirin-like medications
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for migraines, such as sumatriptan
• Certain medications for seizures
• Diuretics
• Lithium
• Medications that treat or prevent blood clots, such as warfarin
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Opioids
• Quinidine
• St. John's wort
• Stimulant medications for ADHD, weight loss, or staying awake
• Tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What is Trintellix® used for?

Vortioxetine (Trintellix) has approval from the U.S. Food and Drug Administration (FDA) to help treat major depressive disorder (clinical depression).

Providers sometimes prescribe Trintellix for other conditions. This is an off-label, or non-FDA-approved, use of the medication. Off-label uses of Trintellix may include generalized anxiety disorder and obsessive-compulsive disorder.

Does Trintellix cause weight gain?

Weight gain isn’t a listed side effect of Trintellix, but some people have reported this since its FDA approval. It’s important to remember that several factors can contribute to weight gain. For example:

Untreated depression can lead to loss of appetite and unexpected weight loss. Taking an antidepressant (like Trintellix) can improve your mood and restore your appetite. A restored appetite might result in eventual weight gain.

Adults tend to gain weight as they age in general.

If you’re concerned about recent weight gain, talk to your healthcare provider. They can recommend strategies to help you achieve a healthy weight for you.

How long does Trintellix take to work?

It can take four to twelve weeks before you experience a significant improvement in your anxiety and/or depression symptoms.

Talk to your healthcare provider if you don’t notice a change in your symptoms. It may take time to find the right antidepressant for you. Try not to give up.

Can Trintellix be cut in half?

Don’t cut your pills in half unless your healthcare provider says to do so. You should always take Trintellix and other prescription medications exactly as directed by your provider. Don’t take more or less of the medication than prescribed.

In addition, don’t suddenly stop taking Trintellix or try to go off it by yourself. This can cause antidepressant discontinuation syndrome. Talk to your provider first if you’re thinking of going off the medication.