Vortioxetine

TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.

The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.

The recommended starting dose is 10 mg administered orally once daily without regard to meals. The dose should then be increased to 20 mg/day, as tolerated. Consider 5 mg/day for patients who do not tolerate higher doses. TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible. The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers.

Hypersensitivity to vortioxetine or any component of the formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX. The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of serotonin syndrome. The use of TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Boxed warning (suicidal thoughts and behaviors): Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. TRINTELLIX is not approved for use in pediatric patients. Serotonin Syndrome: Increased risk when coadministered with other serotonergic agents, but also when taken alone. If it occurs, discontinue TRINTELLIX and serotonergic agents and initiate supportive measures. Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, or other drugs that affect coagulation may increase risk. Activation of Mania/Hypomania: Screen patients for bipolar disorder.

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity Clinical Worsening and Suicide Risk Serotonin Syndrome Increased Risk of Bleeding Activation of Mania/Hypomania Discontinuation Syndrome Angle Closure Glaucoma Hyponatremia Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting.

Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered. Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose.

Store at 77°F (25°C), excursions permitted to 59°F to 86°F (15°C to 30°C).