Trintellix (Vortioxetine)

Trintellix is not recommended:

• If you are allergic or have had an allergic reaction to Trintellix or ingredients in Trintellix
• If you are pregnant or breastfeeding
• For patients under 18 years of age

What are the Indications for Trintellix?

Trintellix is approved for the treatment of major depressive disorder.

How is Trintellix used?

Storage

Trintellix should be stored at room temperature 25°C (77°F) in its original packaging away from heat and moisture.

Keep it out of reach of children.

Instructions

Take Trintellix by mouth, as directed by your doctor, with or without food at the same time every day. Swallow the tablet whole. Do not chew, split, or crush the capsule or tablet.

Trintellix begins to work after the first dose, but it can take up to 2 weeks to see the maximum benefit. Take the medication even if you feel well as your doctor will likely recommend that you take it long-term.

Do not change your dosage and take more than what is prescribed, or stop using Trintellix suddenly or without consulting with your doctor. You may experience symptoms like mood swings, headache, muscle stiffness and a runny nose if you stop this drug suddenly. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, only take one dose. Do not take more than one dose at a time.

Dosage

Trintellix is available in tablet form in the following strengths: 5 mg, 10 mg, and 20 mg. The recommended starting dose is 10 mg administered orally once daily with or without food. Your doctor may increase or decrease your dosage depending on how well it’s working for you.

Side Effects

It’s important to understand that although Trintellix is FDA approved, it comes with side effects that may or may not affect you.

Before starting Trintellix, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Trintellix, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.

• Nausea
• Diarrhea
• Dry mouth
• Constipation
• Vomiting
• Gas
• Dizziness
• Abnormal dreams
• Itching
• Decreased sexual desire

Serious Side Effects

Severe adverse reactions while taking Trintellix may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
• Vision changes, eye pain, redness, swelling widened pupils or blurred vision.
• Easy bruising, unusual bleeding, coughing up blood.
• Low sodium level: confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady.
• Allergic reaction: rash, itching, swelling, severe dizziness or trouble breathing.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Trintellix, tell your doctor or pharmacist:

• If you are allergic to Trintellix or any ingredients in Trintellix
• If you are pregnant or plan to become pregnant
• If you are breastfeeding or plan to breastfeed
• If you have a personal or family history of bipolar/manic-depressive disorder or suicide attempts

Serious bleeding

Trintellix can increase the risk of bleeding, from mild nosebleeds to more serious bleeding in the stomach or brain.

Symptoms include bleeding that is severe or uncontrollable, discolored urine or stools, coughing up blood and vomiting blood.

Low sodium levels

Trintellix can cause low sodium levels, especially if you are older than 65 or take diuretic medication. It can become serious if left untreated.

Symptoms include headache, confusion, weakness or unsteadiness and trouble concentrating.

Worsening symptoms of depression or suicidal thoughts

Although it’s rare, you can experience worsening depression symptoms and have thoughts of suicide when taking Trintellix. Please contact your doctor or the emergency room immediately if you have any suicidal thoughts.

Sexual side effects

You may experience sexual side effects from taking Trintellix and it can include a decreased libido, erectile dysfunction, inability to have an orgasm or ejaculate and vaginal dryness.

Insomnia

You could experience insomnia (trouble sleeping) while taking Trintellix. If this does not go away after continued use, please consult your doctor.

Glaucoma or eye conditions

Trintellix can cause an eye condition called glaucoma. If you already have glaucoma or another eye condition, consult your doctor before starting Trintellix. Trintellix can also cause vision changes so your eyes should be monitored while taking the medicine.

Suicidal thoughts or behaviors

Although rare, it’s possible for Trintellix to cause suicidal thoughts or behaviors, especially if you are between the ages of 18 and 24 years. Please contact your doctor or visit the emergency room if you experience any suicidal thoughts.

Withdrawal symptoms

Do not suddenly stop taking Trintellix as it’s possible that you may experience withdrawal symptoms. Symptoms include nausea, sweating, mood changes, dizziness, ‘pins and needles’, tremor, confusion, headache, sleepiness, insomnia, seizures, ringing in your ears or mild mania.

If you need to stop taking Trintellix, speak to your doctor about the best way to do so. It’s possible to avoid withdrawal symptoms by slowly reducing your dose of medication.

Alcohol

If you drink alcohol while taking Trintellix, you may have an increased risk of certain side effects, such as dizziness, nausea and vomiting, and bleeding.

If you want to drink alcohol while taking Trintellix, speak to your doctor about how much alcohol, if any, is safe for you to consume.

Pregnant or Planning to Become Pregnant

It’s not known if Trintellix is safe to take during pregnancy. If taken late in your pregnancy may increase the risk of complications in the newborn baby.

If you stop taking Trintellix during pregnancy, you could develop symptoms of depression. If you’re pregnant, consult your doctor about the benefits and risks of taking Trintellix during your pregnancy.

Breastfeeding or Planning to Breastfeed

It’s not known if Trintellix will pass through to human milk, or the effect on a breastfeeding child.  Please speak to your doctor about the risks and benefits of breastfeeding while using Trintellix.

Interactions & Contraindications

Before using Trintellix, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Other medicines or supplements

Trintellix can interact with several types of medicines and change how Trintellix works or increase the risk of side effects. Some of these are:

• monoamine oxidase inhibitors (MAOIs),
• serotonin-norepinephrine reuptake inhibitors (SNRIs)
• selective serotonin reuptake inhibitors (SSRIs)
• migraine medications called triptans
• tricyclic antidepressants (TCAs)
• certain pain medications
• the mood stabilizer, lithium
• the anxiety drug, buspirone
• amphetamines
• blood thinners

Serotonin syndrome

Trintellix increases the serotonin levels in your body and can increase your risk for developing serotonin syndrome. This is a drug reaction that can be dangerous. Do not take Trintellix with other drugs that increase serotonin levels, like the herbal supplement, St John’s wort.

Symptoms of serotonin syndrome can include confusion, irritability, anxiety, muscle spasms or tremors, diarrhea, rapid heartbeat, and high blood pressure

Frequently Asked Questions