Ingrezza (valbenazine) is the first medication approved by the Food and Drug Administration for treating adults with tardive dyskinesia (TD). TD is a serious side effect from long-term use of certain medications, especially antidepressants or antipsychotics.
Ingrezza is a vesicular monoamine transporter type 2 (VMAT2) inhibitor. It works by altering neurotransmitters, chemicals that transmit signals in the brain. VMAT2 molecules help transport and recycle neurotransmitters in the brain. Inhibiting them will cause depletion of brain chemicals, such as dopamine, which are critical for motor control.
VMAT2 inhibitors are used to treat other medical conditions as well, such as Huntington’s disease. This medication may reduce the symptoms of TD, but it is not a cure. The medication requires a prescription from a physician and may only be available at select pharmacies.
Uses
Ingrezza is an oral medication that’s available as a capsule. It’s used to treat uncontrollable movements of the face, tongue, or other body parts caused by TD.
TD may result from prolonged use of certain medications used to treat psychiatric disorders, nausea, and gastrointestinal disorders. Not everyone on these medications will necessarily develop TD. However, depending on your risk factors, how long you are on the medication, and the doses you are on, you may be more likely to develop the condition.
Before Taking
Before prescribing, your doctor will evaluate you for your condition status, liver functions, and any potential drug interactions. If you have hypersensitivity to Ingrezza or any component of the medication, then this medication is not appropriate for you.
It is crucial that you take this medication daily and do not miss any doses if possible. You should also know the possible side effects before starting this medication.
Inform your doctor if you are pregnant or breastfeeding. It is unclear if Ingrezza is present in breast milk. The manufacturer does not recommend breastfeeding during therapy or until five days after the last dose.
Overall, it is important that you follow your doctor’s instructions carefully and consult with your pharmacist if you have any questions about this medication.
Precautions and Interactions
There are some clinical concerns related to the adverse effects of this medication:
What Was Used to Treat Tardive Dyskinesia Before Ingrezza?
Prior to Ingrezza coming into the market, there has been no well-studied treatment for TD. Management strategies included utilizing off-label medications or supplements, such as tetrabenazine, clonazepam, or Ginkgo biloba.
- Impaired cognitive function: Ingrezza may impair physical or mental abilities, so you must be cautious about performing tasks that require mental alertness while on this medication, such as operating machinery or driving.
- Depression and suicidal ideation: Vesicular monoamine transport inhibitors have been associated with depression and suicidal thoughts and behavior. In one study, the majority of patients who reported no suicidal ideation at baseline continued to have no suicidal ideation at any time during the study. Only four patients (two on placebo and two on Ingrezza) reported that they had suicidal thoughts. It’s therefore important to monitor your mood and symptoms while taking Ingrezza.
- Parkinsonism: Cases of Parkinson-like symptoms, such as falls, gait disturbances, tremors, drooling, and reduced muscle movement have been reported in people who take Ingrezza. The onset of severe symptoms occurs most commonly within two weeks of starting this medication or increasing the dosage. These symptoms may resolve when the therapy is discontinued. Your doctor may either reduce your dose or stop the medication if you develop clinically significant Parkinson-like symptoms.
- Irregular heart rhythm: This medication may affect the heart by prolonging the QT interval, which increases the risk of developing an irregular heartbeat that may cause fainting or sudden death. It is advisable to use caution when Ingrezza is used at the same time as a strong CYP2D6 inhibitor (such as bupropion, fluoxetine, paroxetine, quinidine, or terbinafine) or CYP3A4 inhibitor (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, or even grapefruit) because a dose reduction may be necessary.
If you are an individual who cannot break down this drug easily, also known as a poor CYP2D6 metabolizer, your doctor may reduce your dose.
It is best to avoid using Ingrezza if you have congenital long QT syndrome or arrhythmias associated with a prolonged QT interval. If you are at risk of a prolonged QT interval, your doctor will need to perform an electrocardiogram (ECG) before increasing your dosage.
Other VMAT2 Inhibitors
As of 2021, in addition to Ingrezza, there are two other VMAT2 inhibitors that are available in the United States: Xenazine (tetrabenazine) and Austedo (deutetrabenazine). Xenazine is indicated for treating Huntington’s disease and has an off-label use for TD, while Austedo is indicated for treating both Huntington’s chorea and TD.
Two randomized, double-blind, placebo-controlled trials, named Kinect 2 and Kinect 3, provided data for the safety and efficacy of Ingrezza. Unlike previous VMAT inhibitors, Ingrezza showed effectiveness with a limited side effect profile.
Dosage
For tardive dyskinesia, the initial dose is 40 mg once daily by mouth, and after one week the doctor can increase it to 80 mg once daily. Based on response and tolerability, patients can continue taking doses of 40 or 60 mg once daily.
The product is available in three strengths: 40 mg, 60 mg, and 80 mg. The medication does not need to be adjusted even if you have kidney problems. However, if you have moderate to severe liver problems, your maximum dose would be 40 mg daily since the medication is broken down by the liver.
Your doctor will prescribe your dosage based on your condition, response to treatment, and other medications you are taking. Therefore, it is important to inform your doctor and pharmacist about all the products you use, including prescription drugs, nonprescription drugs, and supplements.
How To Take and Store
This medication can be taken once daily by mouth with or without food, as directed by your doctor. To maximize its benefits and improve your medication adherence, take it at the same time each day. If you missed a dose, take it immediately when you remember. If it is the next scheduled dose, take that day’s dose only and do not double up since you will experience more side effects.
When to Call Your Doctor
In case of an overdose, call the poison control helpline at 1-800-222-1222 or check their website for more information. If your loved one is in a critical condition, such as if they have collapsed, had a seizure, have trouble breathing, or can’t be awakened, call 911.
Tell your doctor if your condition does not get better or if it gets worse. Your doctor may start at a low dose and gradually increase your dose to reduce your risk of side effects.
This medication should be kept in its original container and tightly closed. It is best to store it at room temperature and in a place that will remind you to take your medication daily. You should keep it away from excess heat and moisture, such as in the bathroom.
In terms of disposal of unneeded medications, talk to your pharmacist or dispose of it at one of the Drug Enforcement Administration’s (DEA) take-back programs. Since many of the containers are not child-resistant, it is recommended to keep them in a safe place (one that is up and away and out of their sight and reach) to ensure that pets, children, and other people cannot consume them.
Many police stations also have locked drop boxes that people can drop off unused, damaged, or expired meds, not for needles though. Towns halls also provide this service sometimes.
The FDA’s Safe Disposal of Medicines website or the DEA’s National Prescription Drug Take-Back Day website contains more information on disposal if you do not have access to a take-back program.
Side Effects
Ingrezza may cause side effects. The most common side effects are drowsiness, fatigue, and sedation. Other less common side effects include having an abnormal gait, restlessness, anxiety, insomnia, vomiting, and weight gain.
Ingrezza has some rare but serious side effects that may require emergency medical treatment, such as hives, skin rash, swelling of the face, lips, or mouth, or fast or irregular heartbeat. Call your doctor if you have any unusual problems while taking this medication.
Warnings and Interactions
Ingrezza has many drug interactions, so it is crucial that you inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
Certain medications will affect the dose of Ingrezza, such as carbamazepine (an anti-seizure medication), phenytoin (an anti-seizure medication), clarithromycin, digoxin (a heart medication), fluoxetine, itraconazole, ketoconazole, paroxetine, quinidine, and rifampin (an antibiotic).
If you are taking monoamine oxidase inhibitors (MOAIs), such as isocarboxazid, phenelzine, selegiline, and tranylcypromine to treat your depression, panic disorder, or anxiety disorders, your doctor will not start you on Ingrezza. The medication may lead to an increased risk of toxicity and adverse reactions, including serotonin syndrome.
Serotonin syndrome, which is incredibly rare, consists of agitation, confusion, muscle rigidity, heavy sweating, and high blood pressure. Call 911 immediately if you are experiencing these symptoms while taking Ingrezza with another MOAI.
If you are taking herbal products, especially St. John’s wort, your doctor will need to change the dose since St. John’s wort lowers the level of Ingrezza in your body. Overall, if you are starting any new medications, talk to your doctor and pharmacist so they can provide their expert guidance to give you the best care.
Frequently Asked Questions
Can I fill my Ingrezza at any pharmacy?
No, it is available at select specialty pharmacies, so check with your prescription insurance company for more information on where to fill your medication.
How much does Ingrezza cost?
It depends on your dose and prescription insurance benefits. An average one-month supply for most patients of 30 capsules can range from $7,107.84 to $8,685 for the 80 mg strength.
Are there any financial assistance programs for the medication?
The company Neurocrine offers a patient assistance program. You can visit their website or call 1-844-647-3992 for more information. Your doctor needs to provide you with a valid prescription and you have to provide proof of household income to qualify.
Can I stop Ingrezza if I cannot tolerate the side effects?
Talk with your doctor before stopping the medication since sudden discontinuation of the medication may worsen your symptoms. You can consult with your pharmacist or doctor about the side effects, and they can help you manage your symptoms.
My friend or a relative has tardive dyskinesia. Can I share my Ingrezza with my friend or a loved one?
You should not share your medication with anyone for several reasons. First, your insurance will only pay for a certain amount of medications each month, so you will not have enough if you share. Secondly, everyone’s liver function and the severity of their condition may be different. They may require a different dose. In addition, you want them to be seen by a healthcare professional prior to taking the medication.
If I am to be admitted to the hospital, should I take Ingrezza with me to the hospital?
Since the medication is expensive and is only available at certain pharmacies, bring your home medication to the hospital or other facilities in case they do not carry it. It may take days for the hospital to order the medication and be administered to you at the hospital. When you go home from the hospital, make sure you ask the nurse to return your medication on the day of discharge, or else they will destroy it within a month of your discharge.