General Information
Manufacturer: Neurocrine Biosciences
Medical Name: valbenazine
Purpose: Ingrezza is used in the treatment of tardive dyskinesia
Common Side Effects
| Side Effect | Ingrezza | Placebo |
|---|---|---|
| Somnolence (sleepiness, fatigue, sedation) | 10.9% | 4.2% |
| Anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention) | 5.4% | 4.9% |
| Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder) | 4.1% | 2.2% |
| Headache | 3.4% | 2.7% |
| Akathisia (restlessness) | 2.7% | 0.5% |
| Vomiting | 2.6% | 0.6% |
| Nausea | 2.3% | 2.1% |
| Arthralgia (joint pain) | 2.3% | 0.5% |
Serious Side Effects
| Side Effect | Description |
|---|---|
| Hypersensitivity reactions | These can include life-threatening angioedema (swelling of the face, lips, tongue, or throat). While the exact percentage in controlled studies for TD was not specified, these have been reported in postmarketing use. |
| Neuroleptic Malignant Syndrome (NMS) | A potentially fatal condition with symptoms like high fever, severe muscle stiffness, confusion, and irregular heartbeat. The incidence is not precisely quantified but is a known risk for drugs that affect dopamine levels. |
| Parkinsonism | Development of parkinson-like symptoms such as stiffness, slowed movements, tremors, drooling, and balance problems. In clinical studies for TD, parkinson-like events occurred in 3% of Ingrezza patients compared to less than 1% of placebo patients. |
| QT Prolongation | Ingrezza may cause a heart rhythm problem. Patients with a history of heart rhythm issues or who take certain other medications are at higher risk. |
| Depression and Suicidal Thoughts/Actions (in Huntington's Disease patients) | A boxed warning advises that Ingrezza can increase the risk of depression and suicidal ideation/behavior in patients with Huntington's disease. In a study for Huntington's, depression occurred in 4.7% of patients on Ingrezza versus 1.6% on placebo. |
Preconditions
| Precondition | Description |
|---|---|
| Hypersensitivity | A history of allergic reactions, including rash, hives, or angioedema (swelling of the face, lips, and mouth), to valbenazine or any components of Ingrezza is a contraindication. |
| Heart Conditions | Ingrezza may cause a slight increase in the QT interval (a measure of heart rhythm). Its use should be avoided in patients with congenital long QT syndrome or arrhythmias associated with a prolonged QT interval. |
| Drug Interactions | |
| Monoamine Oxidase Inhibitors (MAOIs) | Concomitant use with MAOIs is avoided, or within 14 days of discontinuing an MAOI, as it may increase the concentration of monoamine neurotransmitters and raise the risk of adverse reactions. |
| Other VMAT2 Inhibitors | Ingrezza should not be used concurrently with other VMAT2 inhibitors like tetrabenazine (Xenazine) or deutetrabenazine (Austedo). |
| Strong CYP3A4 Inducers | Concomitant use with strong inducers of the CYP3A4 enzyme is not recommended. |
| Specific Populations & Conditions | |
| Severe Renal Impairment | Use is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). |
| Hepatic Impairment | While not entirely precluded, a reduced dose is necessary for patients with moderate or severe hepatic impairment. |
| Depression and Suicidality (in Huntington's Disease patients) | VMAT2 inhibitors carry a Black Box Warning regarding an increased risk of depression and suicidal thoughts or behavior in patients with Huntington's disease. Caution is advised, and patients must be closely monitored. |