Xenazine® (tetrabenazine) Frequently Asked Questions
You are encouraged to report negative side effects of Xenazine® (tetrabenazine) to the Xenazine Information Center (XIC) at 1-888-882-6013 or to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Xenazine ® (tetrabenazine )?
Xenazine is the only FDA-approved treatment for chorea associated with Huntington’s disease. It treats a symptom of Huntington’s disease (HD) called chorea (kor-EE-ya), or involuntary movements. These movements can be brief, repetitive and jerky or uncontrolled and dance-like.
Xenazine is a medicine that may reduce the involuntary movements of HD chorea but cannot cure the cause of these movements. It’s not known whether Xenazine is safe and effective in children.
How does Xenazine® (tetrabenazine) work?
How Xenazine exactly reduces HD chorea is not known. It is thought that Xenazine reduces the amount of certain chemicals in the brain that help control body movement.
In a 12-week clinical study with HD patients, Xenazine reduced chorea in more than two-thirds of the individuals who took it, while one-third stayed the same or worsened. The most commonly reported side effects in studies with Xenazine were sleepiness, trouble sleeping, depression, tiredness, anxiety, restlessness, agitation and nausea.
Xenazine is a medicine that may reduce the involuntary movements of HD chorea but cannot cure the cause of these movements.
Who should not take Xenazine® (tetrabenazine)?
- Are depressed or have thoughts of suicide.
- Have liver problems.
- Are taking a monoamine oxidase inhibitor (MAOI) medicine. Ask your doctor or pharmacist if you are not sure.
- Are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan® and Renese®-R) with Xenazine. If your doctor plans to switch you from taking reserpine to Xenazine, you must wait at least 20 days after your last dose of reserpine before you start taking Xenazine.
What should I tell my doctor before taking Xenazine® (tetrabenazine)?
Tell your doctor about all your medical conditions, including if you:
- Have emotional or mental problems (for example, depression, nervousness, anxiety, anger, agitation, psychosis, previous suicidal thoughts or suicide attempts).
- Have liver disease.
- Have any allergies. See the end of the Medication Guide for a complete list of the ingredients in Xenazine.
- Have breast cancer or a history of breast cancer.
- Have heart disease that is not stable, have heart failure or recently had a heart attack.
- Have an irregular heartbeat (cardiac arrhythmia).
- Are pregnant or plan to become pregnant. It is not known if Xenazine can harm your unborn baby.
- Are breast-feeding. It is not known if Xenazine passes into breast milk.
Tell your doctor about all the medicines you take, including prescription medicines and non-prescription medicines, vitamins, and herbal products. Using Xenazine with certain other medicines may cause serious side effects. Do not start any new medicines while taking Xenazine without talking to your doctor first.
How do I take Xenazine® (tetrabenazine)?
Xenazine is a tablet you swallow. You can take Xenazine with or without food. Xenazine comes in two different tablet sizes, 12.5 milligrams (mg) and 25 mg.
You should always take Xenazine as prescribed by your doctor. Finding the right dose is an essential part of your treatment, and the right dose is different for everyone. Depending on your or your loved one’s condition and previous history with taking Xenazine, your doctor will start slowly and may increase the strength and number of tablets (dose) you take over the course of several weeks up to a few months.
Tell your doctor if you stop taking Xenazine for more than 5 days. Do not take another dose until you talk to your doctor.
The process of slowly increasing your dose is also known as titration. Your doctor may give you a dosing schedule to help you keep track of when and how much Xenazine to take. If your doctor thinks you need to take more than 50 mg of Xenazine each day, you will need to have a blood test to see if a higher dose is right for you.
While taking Xenazine, it is important to remain patient since it may take awhile for your physician to find the right dose that works for you. During this time, you may experience some side effects, so be sure to communicate with your doctor about how you are feeling. Some side effects are dose-dependent, and may decrease as your dose is decreased. Your doctor may adjust your dose.
Be sure to contact your doctor if your chorea is not decreasing enough, as this may be a sign that your dose needs to be increased.
Is it okay to take Xenazine® (tetrabenazine) with all my other medications?
Tell your doctor about all the medicines you take, including prescription medicines and nonprescription medicines, vitamins and herbal products. Using Xenazine with certain other medicines may cause serious side effects. Do not start any new medicines while taking XENAZINE without talking to your doctor first. If you’re getting other medications from a local pharmacy, it’s a good idea to tell the pharmacist you’re taking Xenazine.
When will Xenazine® (tetrabenazine) start working?
The dose of Xenazine may be different for every person. Your dose will depend on factors such as:
- How your body breaks down and responds to the medicine.
- Whether side effects are a problem for you.
Your doctor will start you on a low dose of Xenazine. For some people, a low dose works fine, but your doctor may need to gradually increase your dose to find the right dose to reduce your HD chorea. This process is called titration. If your doctor thinks you need to take more than 50 mg of Xenazine each day, you will need to have a blood test to see if a higher dose is right for you. It may take several weeks for your doctor to find the correct dose for you. Talk to your doctor if you don’t think Xenazine is working for you.
What are the possible side effects of Xenazine® (tetrabenazine)?
Xenazine can cause serious side effects, including:
- Depression, suicidal thoughts or actions.
- Neuroleptic malignant syndrome (NMS), a potentially fatal side effect. Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause:
- High fever
- Stiff muscles
- Problems thinking
- Very fast or uneven heartbeat
- Increased sweating
- Parkinsonism. Symptoms of parkinsonism include: slight shaking, body stiffness, trouble moving or keeping your balance.
- Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
- Trouble swallowing. Xenazine may increase the chance that you will have trouble swallowing. Increased coughing may be the first sign that you are having trouble swallowing. Trouble swallowing increases your risk of pneumonia.
- Irregular heartbeat. Xenazine increases your chance of having certain changes in the electrical activity in your heart which can be seen on an electrocardiogram (EKG). These changes can lead to a dangerous abnormal heartbeat. Taking Xenazine with certain medicines may increase this chance.
- Dizziness due to blood pressure changes when you change position (orthostatic hypotension). Change positions slowly from lying down to sitting up and from sitting up to standing when taking Xenazine. Tell your doctor right away if you get dizzy or faint while taking Xenazine. Your doctor may need to watch your blood pressure closely.
- Tardive dyskinesia (TD). TD is a condition where there is repeated facial grimacing that cannot be controlled, including sticking out of the tongue, smacking of the lips, puckering and pursing of the lips, and rapid eye blinking. Xenazine works like other drugs that can cause TD. If you get TD with Xenazine, it is possible that the TD will not go away.
The most commonly reported side effects in studies with Xenazine were sleepiness, trouble sleeping, depression, tiredness, anxiety, restlessness, agitation and nausea.
You or your loved one should always talk to your doctor about any problems or side effects you are having. Do not stop taking Xenazine without talking to your doctor first. Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.
What should I do if I have a side effect?
If you think you’re having a side effect from Xenazine® (tetrabenazine), “call your doctor,” says Christine Hunter, RN, nurse manager of the HDSA Center of Excellence at Baylor College of Medicine. “There are many different things we can do to manage side effects.”
It’s important to call your doctor as soon as you notice a side effect. Your doctor may decrease your dose. Some side effects are dose-dependent, and may decrease as your dose is adjusted.
Do not stop taking Xenazine without talking to your doctor first. Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.
What happens if I skip a dose of Xenazine® (tetrabenazine) or stop taking it?
Before starting Xenazine, you should talk to your healthcare provider about what to do if you miss a dose. If you miss a dose and it is time for your next dose, do not double the dose.
If you stop taking Xenazine, your chorea may return or worsen 12–18 hours after you took the last dose. Tell your doctor if you stop taking Xenazine for more than 5 days. Do not take another dose until you talk to your doctor.
Xenazine® (tetrabenazine) has a boxed warning. What does that mean?
A boxed warning, according to the FDA, is the most serious warning for a prescription medication. Boxed warnings highlight important safety information and help doctors and nurses understand how to handle it.
The boxed warning for Xenazine warns of the increase in risk of depression and suicidal thoughts and behavior in patients taking Xenazine. Anyone considering the use of Xenazine must balance the risks of depression and suicidality with the clinical need for control of HD chorea.
You or your loved one should not start taking Xenazine if you are depressed (have untreated depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings, or worsening depression. This is especially important when Xenazine is started and when the dose is changed.
How much does Xenazine® (tetrabenazine) cost, and will my insurance pay for it?
If you and your doctor decide that Xenazine is right for you, your doctor will fax a prescription form to the Xenazine Information Center (XIC).
If you have prescription insurance, an XIC representative will contact your insurance company to see whether your insurance plan will cover Xenazine. The XIC representative will then call you to discuss your co-pay amount. If you have concerns about paying for Xenazine, you should discuss them with the XIC representative, who will explain the financial assistance programs that are available to those who qualify.
Most people taking Xenazine pay a monthly co-pay of $50 or less. If you ask about and qualify for assistance, your co-pay could potentially drop to zero.
If you do not have prescription insurance or if your insurance does not cover Xenazine, you may qualify to get Xenazine at no cost, through a patient assistance program. Ask an XIC representative about the financial assistance programs that are available.
If your situation changes, you may call the XIC at any time during your Xenazine therapy to ask about financial assistance. The XIC can be reached toll-free at 1-888-882-6013.
How do I get my Xenazine® (tetrabenazine) prescription filled?
Getting your prescription is different from many medications. You cannot get Xenazine from your local pharmacy or mail-order pharmacy.
Instead, your Xenazine prescription will be coordinated through the Xenazine Information Center and will be mailed to you by a specialty pharmacy. The exact specialty pharmacy that will send your medication depends on your insurance plan. The pharmacy could be Accredo, Caremark, Curascript, or Advanced Care Scripts (ACS).
Here’s the process:
- Your doctor will fax your Xenazine prescription — also known as a treatment form — to the Xenazine Information Center.
- A representative from the Xenazine Information Center will check whether your insurance covers Xenazine or if there are any restrictions.
- The representative will then call you to discuss your co-pay and to let you know which specialty pharmacy will be sending you your medication.
- All refills will be managed by the specialty pharmacy.
The specialty pharmacy will also remind you when it’s time to refill your prescription for Xenazine. Please read the Medication Guide that comes with Xenazine every time you refill your prescription.