The first and only study to measure patient-reported TD impact using multiple validated scales
Data on file. Neurocrine Biosciences, Inc.
This website is intended for US healthcare professionals only.
FOR ADULTS WITH TARDIVE DYSKINESIA (TD)
Rapid and robust efficacy at Week 6 with most seeing a response as early as Week 21-3,*
Patients reported improvements in TD impact at Week 242,†
59% of patients reached symptomatic remission at Week 482,4,‡
FOR ADULTS WITH TARDIVE DYSKINESIA (TD)
| ‡ |
Post hoc analysis from open-label KINECT 4. 59% of completers (n/N=61/103) achieved remission at Week 48. Remission defined as ≤1 on each AIMS item 1–7 at Week 48. Results are descriptive. |
More than reductions in TD severity—achieve remission with INGREZZA® (valbenazine) capsules1,4,5,†
SEE REMISSION DATA| * |
80 mg significantly reduced AIMS total score by –3.2 (N=79) vs –0.1 (N=76) for placebo from baseline to Week 6 in KINECT 3. P≤0.001 vs placebo; adjusted for multiplicity. At Week 2, ~52% of patients (n/N=41/79) on INGREZZA 80 mg had a ≥2-point decrease from baseline in AIMS total score. |
| † |
Based on patient-reported improvement on the Tardive Dyskinesia Impact Scale from baseline to Week 24 in open-label KINECT-PRO. No prespecified inferential statistical testing was conducted. Results are descriptive. |
| § |
Based on in vitro VMAT2 binding affinity of dihydrotetrabenazine (HTBZ) metabolites and the primary active metabolite of INGREZZA, + α HTBZ. The clinical significance of in vitro data is unknown and is not meant to imply clinical outcomes. |
Actor portrayals
FOR ADULTS WITH HUNTINGTON’S DISEASE (HD) CHOREA
Rapid and robust HD chorea control in a 12-week clinical study, with most seeing a response as early as 2 weeks, and reductions seen through 2 years1,2,10,||
‖≤80 mg significantly reduced TMC score by –4.6 (N=64) vs –1.4 (N=61) for placebo from baseline to end of treatment (average of Week 10 and Week 12 assessments) in KINECT-HD. P<0.0001 vs placebo. At Week 2, 80% (40 mg, n/N=51/64) had a ≥1-point reduction in TMC score. In open-label KINECT-HD2, –5.2 reduction in TMC score at 104 weeks (≤80 mg, n=87).
VIEW HD CHOREA EFFICACY
Contact a rep, request INGREZZA samples, sign up for email updates, and more.
CONTACT A REPREFERENCES:
INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.
INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.
Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.
INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE.
INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.
INGREZZA and INGREZZA SPRINKLE may cause parkinsonism. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.
The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.
The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including Boxed Warning.
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA, can increase the risk of depression and suicidal thoughts and
INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.
INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.
Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.
INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.
Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.
INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE.
INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.
INGREZZA and INGREZZA SPRINKLE may cause parkinsonism. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.
The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.
The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.
Please see full Prescribing Information, including Boxed Warning.