From the FDA Drug Label
2.3 Dosage Reduction for Patients with Hepatic Impairment
2.4 Dosage Reduction for Patients who are CYP2D6 Poor Metabolizers
Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively.
The dosing for Ingrezza is as follows:
- Standard dosing: 40 mg, 60 mg, or 80 mg of valbenazine free base, respectively.
- Dose reduction is recommended for:
- Patients with moderate or severe hepatic impairment.
- Patients who are CYP2D6 poor metabolizers. No dose adjustment is required for elderly patients or patients with mild, moderate, or severe renal impairment 1.
From the Research
Ingrezza (valbenazine) dosing should be initiated at 40 mg once daily for the first week, then increased to the recommended maintenance dose of 80 mg once daily, as supported by the most recent and highest quality study 2.
Key Considerations
- The medication should be taken with or without food at approximately the same time each day.
- Dose adjustments are necessary for patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15), where the recommended dose is 40 mg once daily.
- Patients taking strong CYP3A4 inhibitors should also have their dose reduced to 40 mg once daily.
- Ingrezza works by selectively inhibiting VMAT2 (vesicular monoamine transporter 2), which regulates the packaging and release of dopamine in the brain, helping to reduce involuntary movements associated with tardive dyskinesia.
- The medication typically takes several weeks to show full effectiveness, and patients should continue taking it as prescribed even if they don't notice immediate improvement.
- Common side effects include somnolence, fatigue, balance disorders, and anticholinergic effects.
Evidence Summary
- A 2025 study published in The Journal of Clinical Psychiatry found that valbenazine was safe and effective in elderly adults who received up to 48 weeks of treatment, with substantial and sustained improvements in tardive dyskinesia symptoms 2.
- Other studies have also demonstrated the efficacy and safety of valbenazine in treating tardive dyskinesia, with similar results to deutetrabenazine 3, 4.
- The most recent and highest quality study 2 provides the strongest evidence for the recommended dosing regimen.