General Information
Manufacturer: Takeda
Medical Name: Vortioxetine (oral route)
Purpose: Trintellix is indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Side Effects
| Side Effect | Trintellix 5 mg/day (%) | Trintellix 10 mg/day (%) | Trintellix 15 mg/day (%) | Trintellix 20 mg/day (%) | Placebo (%) |
|---|---|---|---|---|---|
| Nausea | 21% | 26% | 32% | 32% | 9% |
| Nausea usually occurs during the first week of treatment and is typically mild to moderate in intensity, with a median duration of two weeks. Side effects may be dose-related and can often be managed by adjusting the dosage or taking the medication with food. | |||||
| Diarrhea | 7% | 7% | 10% | 7% | 6% |
| Dry mouth | 7% | 7% | 6% | 8% | 6% |
| Constipation | 3% | 5% | 6% | 6% | 3% |
| Vomiting | 3% | 5% | 6% | 6% | 1% |
| Dizziness | 6% | 6% | 8% | 9% | 6% |
| Abnormal dreams | <1% | <1% | 2% | 3% | 1% |
| Itching (Pruritus) | 1% | 2% | 3% | 3% | 1% |
Other Reported Side Effects
| Side Effect | Description |
|---|---|
| Sexual Dysfunction | This is a common side effect, with overall incidence in male patients ranging from 3% to 5% (vs 2% for placebo), and in female patients up to 2% (vs <1% for placebo). The specific effects may include decreased libido, erectile dysfunction, and difficulty with orgasm. |
| Headache | Reported in clinical trials, but generally not at a rate significantly higher than placebo, except at higher doses in some studies. |
| Insomnia | Trouble sleeping can occur in some patients. |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Serotonin Syndrome | A potentially life-threatening condition, especially when Trintellix is combined with other serotonergic drugs. |
| Increased Risk of Bleeding | Trintellix may increase the risk of bleeding, from easy bruising to more serious gastrointestinal hemorrhage. |
| Mania/Hypomania | May precipitate a manic episode in patients with undiagnosed bipolar disorder. |
| Hyponatremia | A lowering of total body sodium, which is more common in the elderly or those taking diuretics. |
| Suicidal thoughts and behaviors | There is a boxed warning about this risk, particularly in children, adolescents, and young adults. |
Contraindications - Precluding Use
| Precondition | Description |
|---|---|
| Concomitant use with MAOIs | Trintellix should not be used within 14 days of taking MAOIs for psychiatric disorders due to the risk of serotonin syndrome. It also should not be used with other MAOIs like linezolid or intravenous methylene blue. |
| Hypersensitivity | Do not use Trintellix if you have a known hypersensitivity to vortioxetine or any components of the formulation, as reactions like anaphylaxis, angioedema, and urticaria have occurred. |
Warnings and Precautions
| Warning | Description |
|---|---|
| History of Bipolar Disorder or Mania | Trintellix may induce manic episodes in patients with bipolar disorder. Patients should be screened for a personal or family history of bipolar disorder or mania before starting treatment. |
| Increased Risk of Bleeding | Trintellix can increase the risk of bleeding, especially when taken with aspirin, NSAIDs, or anticoagulants like warfarin. |
| Suicidal Thoughts and Behaviors | Patients on antidepressants should be monitored for changes in mood and behavior, particularly suicidal thoughts, especially at the beginning of treatment and with dose adjustments. |
| History of Seizures/Epilepsy | Use with caution in patients with a history of seizures or unstable epilepsy. |
| Children and Adolescents | Trintellix is not approved for use in patients under 18 years old. |
| Angle-Closure Glaucoma | Antidepressants may trigger angle-closure attacks in susceptible individuals. |
| Hyponatremia | Trintellix can lead to low sodium levels, especially in elderly, volume-depleted, or diuretic-taking patients. |