Vortioxetine Dosing in Renal Impairment
No dose adjustment of vortioxetine is required for patients with impaired renal function, regardless of severity. 1
Standard Dosing Regimen
- Start at 10 mg once daily without regard to food, then increase to 20 mg daily if the 10 mg dose is tolerated 2
- For patients who cannot tolerate 20 mg daily, use 10 mg daily, or consider 5 mg daily as the minimum dose 2
- The therapeutic dose range is 5-20 mg once daily 2, 3
Renal Function Does Not Affect Vortioxetine Exposure
- Pharmacokinetic studies demonstrated no clinically meaningful differences in vortioxetine exposure (AUC and Cmax) among subjects with varying degrees of renal impairment compared to those with normal renal function 1
- Clinically meaningful differences were defined as exposure changes between 50% and 2-fold, and renal impairment did not meet this threshold 1
- The 90% confidence intervals for exposure ratios remained within acceptable limits across all degrees of renal dysfunction 1
Metabolism and Elimination Considerations
- Vortioxetine is a medium-clearance drug that undergoes extensive hepatic metabolism via multiple cytochrome P450 isozymes, not renal elimination 1, 3
- The major metabolite is pharmacologically inactive, and renal excretion plays a minimal role in drug clearance 3
- This metabolic profile explains why renal impairment does not significantly impact vortioxetine pharmacokinetics 3
Discontinuation Guidance
- Vortioxetine can be discontinued abruptly without dose tapering 2
- However, for patients taking 15 mg or 20 mg daily, consider reducing to 10 mg daily for 1 week before full discontinuation to minimize potential withdrawal symptoms 2