What is Trintellix (vortioxetine) FDA-approved for in adults, specifically for a patient with a likely diagnosis of major depressive disorder?

Trintellix FDA Approval for Prior Authorization

Trintellix (vortioxetine) is FDA-approved exclusively for the treatment of major depressive disorder (MDD) in adults. 1

FDA-Approved Indication

• The sole FDA-approved indication is: Treatment of major depressive disorder (MDD) in adults 1
• Trintellix is not approved for use in pediatric patients 1

Dosing Information for Prior Authorization

For your prior authorization submission, the FDA-approved dosing parameters are:

• Starting dose: 10 mg orally once daily 1
• Target dose: 20 mg/day as tolerated 1
• Minimum dose: 5 mg/day for patients who do not tolerate higher doses 1
• Maximum studied dose: 20 mg/day (doses above this have not been evaluated in controlled trials) 1
• Administration: Once daily without regard to meals 1

Key Prior Authorization Considerations

Black Box Warning

• Trintellix carries an FDA black box warning for increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, requiring close monitoring for clinical worsening and emergence of suicidal thoughts 1

Dose Adjustments Required for Authorization

• Maximum dose is 10 mg/day in known CYP2D6 poor metabolizers 1
• Reduce dose by one-half when patients are receiving strong CYP2D6 inhibitors (bupropion, fluoxetine, paroxetine, quinidine) 1
• Consider dose increases up to 3 times the original dose when strong CYP inducers (rifampin, carbamazepine, phenytoin) are coadministered for >14 days 1

Clinical Evidence Supporting Approval

• Vortioxetine is recognized as a second-generation antidepressant (SGA) with demonstrated efficacy in MDD treatment 2
• Response rates are significantly higher than placebo for 5 mg (RR=1.33), 10 mg (RR=1.42), and 20 mg doses (RR=1.58) 3
• Remission rates are significantly higher than placebo for 10 mg (RR=1.45) and 20 mg doses (RR=1.68) 3
• Vortioxetine demonstrates favorable tolerability with an NNH of 43 for discontinuation due to adverse events versus placebo 4

Common Pitfall to Avoid

Do not submit prior authorization for off-label uses such as anxiety disorders, cognitive dysfunction alone, or any pediatric indication, as these are not FDA-approved and will likely be denied 1