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Frequently Asked Questions

What is Xenazine?

Xenazine® (tetrabenazine) treats a Huntington's disease symptom called chorea (Kor-EE-ya), or involuntary movements. These movements can be brief, repetitive, jerky, or uncontrolled and dance-like.

Xenazine may reduce the chorea associated with HD so that patients can regain some control over their movements. Xenazine does not cure the cause of Huntington's chorea, nor does it treat any other Huntington's disease symptoms, such as problems with emotions or thinking. It`s not known whether Xenazine is safe and effective in children.

How does Xenazine work?

Xenazine® (tetrabenazine) reduces the activity of chemicals in the brain called monoamines, that include dopamine (DOH-puh-meen). Dopamine helps control body movements. Although the exact mechanism of action is not known, it is thought that by reducing the amount of dopamine, Xenazine will lessen the chorea.

In clinical studies, Xenazine reduced chorea in more than two-thirds of the individuals who took it. On the Clinical Global Impression (CGI) scale, a scale that doctors and researchers use to rate symptom severity or how effective treatments are, 69% of patients improved with Xenazine compared with 24% of patients treated with a placebo (sugar pill).

Xenazine does not cure the cause of chorea, nor does it treat other symptoms of Huntington's disease, such as problems with thinking or emotions.

Who should not take Xenazine?

Do not take Xenazine® (tetrabenazine) if you:

  • 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?

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® (tetrabenazine).
  • 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 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.

How do I take Xenazine?

pills
Tablets not actual size

Xenazine® (tetrabenazine) 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. Depending on you 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.

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. Your doctor may adjust your dose.

What are the possible side effects of Xenazine?

Xenazine® (tetrabenazine) can cause serious side effects, including:

  • Depression, suicidal thoughts, or actions.
  • Neuroleptic Malignant Syndrome (NMS), a potentially fatal side affect. 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, 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.

Common side effects with Xenazine include:

  • sleepiness (sedation)
  • trouble sleeping
  • depression
  • tiredness (fatigue)
  • anxiety
  • restlessness
  • agitation
  • nausea
Tell your doctor if you have any side effects. Do not stop taking Xenazine without talking to your doctor first.

What happens if I skip a dose of Xenazine or stop taking it?

Before starting Xenazine® (tetrabenazine), you should talk to your health care 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 in 12 to 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 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® (tetrabenazine) 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 Huntington's chorea.

How much does Xenazine cost, and will my insurance pay for it?

The Xenazine® (tetrabenazine) Information Center (XIC) is available to talk to you about your prescription coverage. They will make sure that they have your complete and accurate insurance information. If you have not already provided this information, you need to tell them if you have private medical insurance, Medicare, Medicaid, or any other prescription drug coverage.

Most medical insurance policies require a co-payment from you before you get your medicine. Your team member at the XIC will tell you what your co-payment will be for Xenazine.

If you do not have prescription insurance, you may qualify to get Xenazine through a patient assistance program. Your team member at the XIC can help you apply for this assistance program. The XIC can be reached toll-free at 1-888-882-6013.

How do I get my prescription filled?

Xenazine® (tetrabenazine) is mailed to you from a Specialty Pharmacy—you cannot get it from a local drugstore. Your Specialty Pharmacy will contact you to discuss any payments due and confirm a proper shipping address. It may take up to two weeks before you receive your medicine.

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.

XENAZINE® (tetrabenazine) Tablets

Indications and Usage:

XENAZINE is a medicine that is used to treat the involuntary movements (chorea) of Huntington’s disease. XENAZINE does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

It is not known whether XENAZINE is safe and effective in children.

Important Safety Information:

  • XENAZINE can cause serious side effects, including:
    • depression
    • suicidal thoughts
    • suicidal actions
  • You should not start taking XENAZINE if you are depressed (have untreated depression or 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.
  • Do not take XENAZINE if you have liver problems or are taking monoamine oxidase inhibitors or reserpine. Ask your doctor or pharmacist if you are not sure. At least 20 days should pass after stopping reserpine before starting XENAZINE.
  • Tell your doctor if you are pregnant, breast-feeding or have breast cancer. Do not start any new medicines while taking XENAZINE without talking to your doctor first.
  • The need for therapy should be evaluated on an ongoing basis with your doctor. The dose of XENAZINE should be adjusted slowly over several weeks for a dose that is appropriate for you. Tell your doctor if you stop taking XENAZINE for more than 5 days. Do not take another dose until you talk to your doctor. 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.
  • Neuroleptic Malignant Syndrome (NMS) is a potentially fatal side effect reported with XENAZINE. 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, or increased sweating. XENAZINE should be stopped immediately if NMS is diagnosed.
  • XENAZINE can also cause other serious side effects, including: parkinsonism (slight shaking, body stiffness, trouble moving or keeping your balance), restlessness (akathisia), trouble swallowing, irregular heartbeat, and dizziness due to blood pressure changes when you change position (orthostatic hypotension). Trouble swallowing may increase the risk of pneumonia. Uncontrolled movements called tardive dyskinesia (TD) may also develop in patients treated with XENAZINE. It is possible that the TD will not go away.
  • Side effects such as irregular heartbeat, NMS, and parkinsonism, may be increased when using XENAZINE with other drugs (e.g., dopamine antagonists).
  • Sleepiness is a common side effect of XENAZINE; do not drive a car or operate dangerous machinery until you know how XENAZINE affects you. Alcohol and other drugs may increase sleepiness caused by XENAZINE.
  • Some side effects, such as depression, tiredness, trouble sleeping, sleepiness, parkinsonism, agitation, and restlessness (akathisia), may be dose-dependent. If the side effects don’t stop or lessen, your doctor should consider lowering the dose or stopping your XENAZINE. The most commonly reported side effects in studies with XENAZINE were sleepiness, trouble sleeping, depression, tiredness, anxiety, restlessness, agitation and nausea.

For more information, please see the full Prescribing Information, including Boxed Warning, the Medication Guide or go to www.XENAZINEusa.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

XENAZINE® is a registered trademark of Valeant International Bermuda

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The product information provided in this site is intended only for residents of the U.S. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.