Trintellix

VORTIOXETINE

Manufacturer: Takeda Pharmaceuticals America, Inc.

Score: 144.0

Quick Summary

Trintellix (Vortioxetine) is an antidepressant used for the treatment of major depressive disorder (MDD) in adults. It works by enhancing serotonergic activity in the central nervous system. The recommended starting dose is 10 mg administered orally once daily, which can be increased to 20 mg/day as tolerated. Trintellix has been associated with several adverse reactions, including nausea, constipation, and vomiting, and has important safety information and contraindications, such as an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, and a risk of serotonin syndrome when used with other serotonergic drugs.

Key Clinical Findings and Indications

Trintellix is indicated for the treatment of major depressive disorder (MDD) in adults
The mechanism of action is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS
Trintellix has been shown to be effective in treating MDD in clinical trials

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

Hypersensitivity to vortioxetine or any component of the formulation
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with Trintellix or within 21 days of stopping treatment with Trintellix

Adverse Reactions

Nausea
Constipation
Vomiting
Serotonin syndrome
Increased risk of bleeding

Dosing Recommendations

General Guidance

The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers

Major depressive disorder (MDD)

Adult Dose

10 mg administered orally once daily, which can be increased to 20 mg/day as tolerated

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy
Trintellix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

It is not known whether vortioxetine is excreted in human milk

Pediatric Use

The safety and effectiveness of Trintellix have not been established in pediatric patients
Trintellix is not approved for use in pediatric patients

Geriatric Use

No dose adjustment is recommended on the basis of age
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients

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