vortioxetine

• Vortioxetine (Trintellix) is an antidepressant used for treating a certain type of depression known as major depressive disorder (MDD). Vortioxetine decreases the reuptake of serotonin just like selective serotonin reuptake inhibitors (SSRIs). It also stimulates various serotonin receptors in the brain.
• The exact mechanism by which vortioxetine helps to improve mood in patients a major depressive disorder is not known. It may have a role in enhancing the activity of the neurotransmitter serotonin in the brain by inhibiting the transport of serotonin. Additionally, vortioxetine appears to block or stimulate some serotonin receptors. The exact contribution of the respective activity of vortioxetine at these receptor sites remain to be understood.
• Vortioxetine was approved by the FDA in September 2013.

What brand names are available for vortioxetine?

Trintellix (formerly known as Brintellix)

Is vortioxetine available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for vortioxetine?

Yes

Vortioxetine is used for the treatment of a certain type of depression known as major depressive disorder (MDD).

The most common side effects of vortioxetine treatment are:

• Nausea,
• Diarrhea
• Dizziness
• Flatulence
• Sexual dysfunction
• Constipation
• Vomiting

• The recommended starting dose for most adult patients is 10 mg once daily. The dose should then be increased to 20 mg per day as tolerated. Vortioxetine may be administered without regard to meals.
• Since vortioxetine is extensively broken down by a group of liver enzymes known as CYP2D6, patients with reduced activity of these enzymes should not be treated with doses higher than 10 mg/day.
• Although vortioxetine may be discontinued without tapering, manufacturer recommends reducing doses of 15 mg/day or 20 mg/day to 10 mg/day for 1 week prior to discontinuation.
• The safety and effectiveness of vortioxetine treatment as not been studied in pediatric patients. The use of vortioxetine in this patient population is not recommended.

To avoid the risk of serotonin syndrome, a rare but serious disorder caused by abnormally high levels of serotonin in the body, vortioxetine should not be used in combination or within 14 days of treatment with monoamine oxidase inhibitors (MOAI). Conversely, treatment with MAOI should not be started until 21 days have passed after stopping vortioxetine.

The potential risk of serotonin syndrome also exists when vortioxetine is co-administered with other drugs that also affect serotonin levels in the brain. Examples of such drugs include:

• Several classes of commonly used antidepressants such as:
  • Selective serotonin reuptake inhibitors (SSRIs)
  • Serotonin norepinephrine reuptake inhibitors (SNRIs)
  • Tricyclic antidepressants (TCAs)
• Triptans used to treat migraine headaches
• Products containing (this is not a complete list):
  • tryptophan
  • tramadol (Ultram, Ultram ER, Conzip),
  • St. John's wort,
  • Amphetamines,
  • methylphenidate (Concerta, Ritalin, Daytrana, Metadate)
  • buspirone (BuSpar)

Serotonin plays an important role in forming blood clots. Use of vortioxetine may increase the risk of bleeding, especially if taken with:

• the blood thinner warfarin (Coumadin or Jantoven),
• aspirin, or
• nnon-steroidal anti-inflammatory drugs (NSAIDS) such as:
  • ibuprofen (Motrin),
  • naproxen (Naprosyn), and
  • indomethacin (Indocin).

Vortioxetine is extensively metabolized or broken down by the CYP2D6 liver enzymes. Strong CYP2D6 inhibitors may increase the blood levels of vortioxetine, and consequently increase the risk for side effects. Examples of strong CYP2D6 inhibitors are bupropion (Wellbutrin), paroxetine (Paxil), and quinidine (Quin-Tab). The dose of vortioxetine should be reduced by half when co-administered with such agents.

Conversely, strong CYP2D6 inducers may decrease the blood levels of vortioxetine, resulting in poor treatment outcomes. Dose of vortioxetine should be increased when administered with strong CYP2D6 inducers such as rifampin (Rimactane), carbamazepine (Tegretol), and phenytoin (Dilantin).

• Vortioxetine has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, vortioxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Vortioxetine is classified as FDA pregnancy risk category C.
• It is not known if vortioxetine is excreted in breast milk. Due to the lack of safety data, vortioxetine should be used cautiously in females who are breastfeeding.

What preparations of vortioxetine are available?

Immediate release oral tablets: 5, 10, 15, and 20 mg.

How should I keep vortioxetine stored?

Tablets should be stored at room temperature between 15 C to 30 C (59 F to 86 F).