What is the indication and dosing for Ingrezza (valbenazine)?

Ingrezza (Valbenazine) Indication and Dosing

Indications

Ingrezza is FDA-approved for two specific indications: treatment of tardive dyskinesia in adults and treatment of chorea associated with Huntington's disease in adults. 1

• Tardive dyskinesia: Involuntary movement disorder typically caused by chronic exposure to dopamine receptor antagonists (antipsychotics) 1, 2
• Chorea associated with Huntington's disease: Hyperkinetic movement disorder characteristic of Huntington's disease 1, 3

Dosing Regimens

For Tardive Dyskinesia

The recommended dosing for tardive dyskinesia is 40 mg once daily for one week, then increase to 80 mg once daily. 1

• Initial dose: 40 mg once daily 1
• After 1 week: Increase to the recommended maintenance dose of 80 mg once daily 1
• Administration: Can be taken with or without food 1

For Chorea Associated with Huntington's Disease

The dosing for Huntington's disease chorea requires slower titration: start at 40 mg once daily, then increase by 20 mg increments every two weeks to reach the target dose of 80 mg once daily. 1

• Initial dose: 40 mg once daily 1
• Titration: Increase in 20 mg increments every 2 weeks 1
• Target dose: 80 mg once daily 1
• Alternative maintenance doses: 40 mg or 60 mg once daily may be considered based on individual response and tolerability 1

Special Population Dosing Adjustments

Hepatic Impairment

For patients with moderate or severe hepatic impairment (Child-Pugh score 7-15), reduce the dose to 40 mg once daily. 1

• Patients with moderate to severe hepatic impairment have higher exposure to valbenazine and its active metabolite 1
• No adjustment needed for mild hepatic impairment 1

CYP2D6 Poor Metabolizers

Known CYP2D6 poor metabolizers should receive a reduced dose of 40 mg once daily. 1

• Poor metabolizers have increased exposure to the active metabolite, which may increase risk of adverse reactions 1

Renal Impairment

No dose adjustment is necessary for any degree of renal impairment. 1

• Valbenazine does not undergo primary renal clearance 1

Elderly Patients

No dose adjustment is required based on age alone. 1

• Safety and effectiveness were similar in patients over 65 years compared to younger patients in clinical trials 1

Drug Interaction Dosing Modifications

Strong CYP3A4 Inhibitors

When coadministered with strong CYP3A4 inhibitors, reduce the valbenazine dose to 40 mg once daily. 1

Strong CYP2D6 Inhibitors

When coadministered with strong CYP2D6 inhibitors, reduce the valbenazine dose to 40 mg once daily. 1

Strong CYP3A4 Inducers

Concomitant use with strong CYP3A4 inducers is not recommended. 1

MAOIs

Avoid concomitant use with monoamine oxidase inhibitors (MAOIs). 1

Formulation Options

Ingrezza is available in two formulations: standard capsules and SPRINKLE capsules, both in 40 mg, 60 mg, and 80 mg strengths. 1

• Standard capsules: Swallow whole 1
• SPRINKLE capsules: May be opened and sprinkled over soft food (do not use milk or drinking water), or swallowed whole with water; do not crush or chew 1

Clinical Efficacy Data

Clinical trials demonstrated substantial improvement in tardive dyskinesia with valbenazine 80 mg daily, achieving a clinically significant effect size of 0.90. 2

• The 40 mg dose showed a lower effect size of 0.52 2
• Long-term studies showed that at week 48, approximately 90% of participants had ≥50% improvement in AIMS total score regardless of whether they were maintained on 40 mg or 80 mg daily 4
• Onset of effect occurs within 2 weeks of treatment initiation 5