What is the recommended dosing schedule for Brintellix (vortioxetine)?

Brintellix (Vortioxetine) Dosing Schedule

Brintellix should be administered orally once daily at 10 mg without regard to meals, with subsequent dose adjustment to 20 mg/day as tolerated, or reduction to 5 mg/day for patients who cannot tolerate higher doses. 1

Standard Dosing Protocol

Starting Dose:

• Initiate treatment at 10 mg once daily taken orally 1
• Can be taken with or without food—no food effect on pharmacokinetics has been observed 2
• Once-daily dosing is appropriate given the mean terminal half-life of approximately 66 hours 2

Dose Titration:

• Increase to 20 mg/day as tolerated for optimal therapeutic effect 1
• Reduce to 5 mg/day for patients who do not tolerate higher doses 1
• Steady-state plasma concentrations are generally achieved within 2 weeks of dosing 2

Timing Considerations

• Administer at the same time each day to maintain consistent plasma levels 1
• No specific time of day is mandated by the FDA label, allowing flexibility based on patient preference 1
• The pharmacokinetics are linear and dose-proportional, supporting once-daily administration 2

Special Population Dosing

CYP2D6 Poor Metabolizers:

• Maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers 1
• This is the only population requiring mandatory dose adjustment 2

No dose adjustment required for:

• Sex, age, race, or body size differences 2
• Renal or hepatic impairment 2

Drug Interaction Dosing Adjustments

Strong CYP2D6 Inhibitors (e.g., bupropion):

• Reduce vortioxetine dose by half when coadministered 1

Strong CYP Inducers (e.g., rifampin):

• Consider dose increase when coadministered for more than 14 days 1
• Maximum recommended dose should not exceed 3 times the original dose 1

Discontinuation Protocol

• Vortioxetine can be discontinued abruptly 1
• However, for doses of 15 mg/day or 20 mg/day, it is recommended to reduce to 10 mg/day for one week prior to full discontinuation if possible 1
• This tapering approach may minimize potential discontinuation symptoms 1

Clinical Efficacy Timeline

• Therapeutic effects on depressive symptoms typically emerge within the first 8 weeks of treatment 3
• Response rates with vortioxetine (53.2%) are superior to placebo (35.2%) in short-term studies 4
• Long-term efficacy (52 weeks) demonstrates superiority over placebo in preventing relapses and recurrences 4