Ingrezza 80mg Sprinkle Capsules
WARNING: This drug may raise the chance of depression and suicidal thoughts or actions in people with Huntington's disease. If you have ever had depression or suicidal thoughts or actions, talk with your doctor. This drug may not be right for you. People who take this drug must be watched closely. Call your doctor right away if you have signs like depression, nervousness, restlessness, grouchiness, panic attacks, or any other changes in feelings, mood, or behavior. Call your doctor right away if you have any thoughts or actions of suicide. @ COMMON USES: It is used to treat tardive dyskinesia. It is used to treat disabling involuntary movements in Huntington's chorea.
Drug Class
Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Pharmacologic Class
VMAT2 Inhibitor
Pregnancy Category
Not available
FDA Approved
Apr 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ingrezza is a medication used to treat uncontrolled, involuntary movements of the face and body, a condition called tardive dyskinesia. It works by helping to balance certain chemicals in the brain that affect movement.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, as instructed by your doctor or healthcare provider.
Administration
You can swallow the medication whole with water. Do not crush or chew the medication. Alternatively, you can open the capsule and sprinkle the contents into a small amount (1 tablespoon; 15 mL) of soft food, such as applesauce, yogurt, or pudding. Avoid mixing it with milk or drinking water. Stir the medication into the soft food and swallow the mixture immediately. Then, drink a full glass of water (8 ounces; 240 mL).
Preparing the Mixture
If needed, the mixture can be stored at room temperature for up to 2 hours. However, discard it after 2 hours if it has not been taken. Do not administer this medication through a feeding tube.
Storage and Disposal
Store your medication at room temperature in a dry place, away from the bathroom. Keep it in the original container with the lid tightly closed. Ensure that all medications are stored in a safe location, out of reach of children and pets.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, as instructed by your doctor or healthcare provider.
Administration
You can swallow the medication whole with water. Do not crush or chew the medication. Alternatively, you can open the capsule and sprinkle the contents into a small amount (1 tablespoon; 15 mL) of soft food, such as applesauce, yogurt, or pudding. Avoid mixing it with milk or drinking water. Stir the medication into the soft food and swallow the mixture immediately. Then, drink a full glass of water (8 ounces; 240 mL).
Preparing the Mixture
If needed, the mixture can be stored at room temperature for up to 2 hours. However, discard it after 2 hours if it has not been taken. Do not administer this medication through a feeding tube.
Storage and Disposal
Store your medication at room temperature in a dry place, away from the bathroom. Keep it in the original container with the lid tightly closed. Ensure that all medications are stored in a safe location, out of reach of children and pets.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Ingrezza exactly as prescribed by your doctor, with or without food.
- Do not stop taking Ingrezza suddenly without talking to your doctor, as this can worsen your symptoms.
- Avoid alcohol or other sedating medications, as Ingrezza can cause drowsiness.
- Be cautious when driving or operating machinery until you know how Ingrezza affects you, as it can cause somnolence or dizziness.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, especially those that affect heart rhythm or are strong CYP3A4 inhibitors.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 40 mg orally once daily; after 1 week, increase to 80 mg orally once daily.
Dose Range:
40 - 80 mg
Condition-Specific Dosing:
tardiveDyskinesia:
Initial 40 mg orally once daily; after 1 week, increase to 80 mg orally once daily. Max 80 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed.
Moderate:
No dosage adjustment needed.
Severe:
Maximum recommended dose is 40 mg once daily.
Dialysis:
Not studied; consider maximum recommended dose of 40 mg once daily.
Hepatic Impairment:
Mild:
No dosage adjustment needed.
Moderate:
Maximum recommended dose is 40 mg once daily.
Severe:
Maximum recommended dose is 40 mg once daily.
Confidence:
High
Pharmacology
Mechanism of Action
Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor. The precise mechanism by which valbenazine exerts its therapeutic effects in tardive dyskinesia is unknown, but it is thought to be mediated through the reversible inhibition of VMAT2, leading to reduced dopamine release from presynaptic terminals.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (extensive first-pass metabolism)
Tmax:
Valbenazine: 0.5-2 hours; alpha-dihydrotetrabenazine (active metabolite): 4-8 hours
FoodEffect:
High-fat meal decreases Cmax by 27% and AUC by 16% for valbenazine, but increases Cmax by 24% and AUC by 20% for the active metabolite. Can be taken with or without food.
Distribution:
Vd:
Valbenazine: 92 L; alpha-dihydrotetrabenazine: 120 L
ProteinBinding:
Valbenazine: ~99%; alpha-dihydrotetrabenazine: ~60%
CnssPenetration:
Yes
Elimination:
HalfLife:
Valbenazine: 15-22 hours; alpha-dihydrotetrabenazine: 15-22 hours
Clearance:
Not available
ExcretionRoute:
Primarily urine (60%), feces (30%)
Unchanged:
<2% in urine
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed within 1-2 weeks.
PeakEffect:
Not precisely defined for clinical effect, but steady-state concentrations reached within 1 week.
DurationOfAction:
Sustained effect with once-daily dosing due to long half-life of active metabolite.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Difficulty focusing
Blurred vision
Trouble urinating
Slow heartbeat
Shortness of breath
Dizziness
Abnormal heartbeat (prolonged QT interval), which can cause:
+ Fast heartbeat
+ Irregular heartbeat
+ Fainting
Symptoms similar to Parkinson's disease, such as:
+ Trouble moving or walking
+ Difficulty controlling body movements
+ Shakiness
+ Balance problems or falls
+ Drooling
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, which can cause:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Angioedema, a severe and potentially life-threatening reaction, which can cause:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, such as:
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Restlessness
* Trouble sleeping
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. Not all side effects are listed here. If you have questions or concerns about side effects, you can also report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Difficulty focusing
Blurred vision
Trouble urinating
Slow heartbeat
Shortness of breath
Dizziness
Abnormal heartbeat (prolonged QT interval), which can cause:
+ Fast heartbeat
+ Irregular heartbeat
+ Fainting
Symptoms similar to Parkinson's disease, such as:
+ Trouble moving or walking
+ Difficulty controlling body movements
+ Shakiness
+ Balance problems or falls
+ Drooling
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, which can cause:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Angioedema, a severe and potentially life-threatening reaction, which can cause:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, such as:
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Restlessness
* Trouble sleeping
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. Not all side effects are listed here. If you have questions or concerns about side effects, you can also report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening or new involuntary movements
- New or worsening symptoms of Parkinson's disease (e.g., tremor, stiffness, slow movement)
- Feeling restless or unable to sit still (akathisia)
- Severe drowsiness or dizziness
- Fainting or feeling lightheaded
- Palpitations or a fast/irregular heartbeat
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Mood changes, depression, or thoughts of self-harm
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline.
Current use of linezolid or methylene blue, as these medications should not be taken with this drug.
Use of any other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, that may interact with this medication. This includes rifampin, St. John's Wort, and certain antiseizure medications. There are many medications that should not be taken with this drug, so it is crucial to disclose all medications you are currently taking.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 5 days after your last dose.
To ensure your safety, it is vital to inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems. This will help determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline.
Current use of linezolid or methylene blue, as these medications should not be taken with this drug.
Use of any other medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, that may interact with this medication. This includes rifampin, St. John's Wort, and certain antiseizure medications. There are many medications that should not be taken with this drug, so it is crucial to disclose all medications you are currently taking.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 5 days after your last dose.
To ensure your safety, it is vital to inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems. This will help determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you have Huntington's disease, be aware that your symptoms may still worsen while using this medication. Immediately contact your doctor if you experience new or worsening symptoms.
This medication may pose a risk to an unborn baby if taken during pregnancy. If you are pregnant or become pregnant while taking this drug, notify your doctor promptly.
Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you. Additionally, consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
If you have Huntington's disease, be aware that your symptoms may still worsen while using this medication. Immediately contact your doctor if you experience new or worsening symptoms.
This medication may pose a risk to an unborn baby if taken during pregnancy. If you are pregnant or become pregnant while taking this drug, notify your doctor promptly.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Confusion
- Hypotension
- QTc prolongation
- Extrapyramidal symptoms (e.g., dystonia, parkinsonism)
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic. Monitor cardiac rhythm (ECG) and vital signs.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): May increase valbenazine and active metabolite exposure. Reduce valbenazine dose to 40 mg once daily.
- QT-prolonging drugs (e.g., quinidine, procainamide, amiodarone, sotalol, ziprasidone, chlorpromazine, thioridazine, moxifloxacin): Use with caution, especially in patients with underlying cardiac conditions or electrolyte abnormalities, due to potential for additive QTc prolongation.
Moderate Interactions
- Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): No dose adjustment needed, but monitor for adverse reactions as exposure to active metabolite may increase.
- Digoxin: Valbenazine is a weak P-gp inhibitor. Monitor digoxin levels if co-administered.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess QTc interval, especially in patients with cardiac disease or those taking other QT-prolonging drugs.
Timing: Prior to initiation, if clinically indicated.
Liver function tests (LFTs)
Rationale: To assess hepatic function, especially if considering dose adjustments for hepatic impairment.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Abnormal Involuntary Movement Scale (AIMS)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Reduction in score indicating improvement in tardive dyskinesia.
Action Threshold: Worsening or lack of improvement may warrant dose adjustment or re-evaluation of treatment.
Clinical assessment for parkinsonism or akathisia
Frequency: Regularly, especially during dose titration
Target: Absence or minimal symptoms.
Action Threshold: Emergence or worsening of symptoms may require dose reduction or discontinuation.
QTc interval
Frequency: As clinically indicated, especially if risk factors for QTc prolongation are present (e.g., concomitant QT-prolonging drugs, cardiac disease, electrolyte abnormalities).
Target: Within normal limits (e.g., <450 ms for males, <470 ms for females).
Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline) may require dose reduction or discontinuation.
Symptom Monitoring
- Worsening or new onset of tardive dyskinesia symptoms
- Symptoms of parkinsonism (e.g., tremor, rigidity, bradykinesia)
- Symptoms of akathisia (e.g., inner restlessness, inability to sit still)
- Somnolence or sedation
- Dizziness
- Signs of QTc prolongation (e.g., palpitations, syncope, dizziness)
- Mood changes or suicidal ideation (rare, but monitor in patients with history of depression)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of valbenazine in pregnant women. Animal studies have shown developmental toxicity (e.g., increased fetal mortality, reduced fetal weight, skeletal abnormalities) at exposures greater than clinical exposure. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is not known whether valbenazine or its metabolites are excreted in human milk. Valbenazine and its metabolites are present in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, including somnolence and effects on motor activity, advise women not to breastfeed during treatment with valbenazine and for 5 days after the final dose.
Infant Risk:
Potential for somnolence, motor activity effects, and other adverse reactions.
Pediatric Use
The safety and effectiveness of valbenazine in pediatric patients have not been established. Tardive dyskinesia is rare in pediatric patients.
Geriatric Use
No dosage adjustment is generally required based on age alone. However, elderly patients may be more sensitive to the adverse effects of valbenazine, particularly somnolence and QTc prolongation. Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Ingrezza is the first FDA-approved medication specifically for tardive dyskinesia.
- The sprinkle capsule formulation allows for administration by opening the capsule and sprinkling the contents on soft food (e.g., applesauce, yogurt) or into a cup of water.
- Patients should be assessed for tardive dyskinesia using a standardized rating scale (e.g., AIMS) before and during treatment.
- Monitor for new or worsening parkinsonism or akathisia, as these can be dose-related side effects.
- Counsel patients on the risk of somnolence and dizziness, especially during initiation and dose titration.
- Consider ECG monitoring in patients with cardiac risk factors or those on concomitant QT-prolonging medications.
Alternative Therapies
- Deutetrabenazine (Austedo) - another VMAT2 inhibitor for tardive dyskinesia and Huntington's chorea.
- Off-label treatments for tardive dyskinesia (e.g., clonazepam, amantadine, ginkgo biloba) - generally less effective or with more side effects than VMAT2 inhibitors.
Cost & Coverage
Average Cost:
Approximately $7,000 - $8,000 per 30 capsules (80mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.