Xenazine

Generic Name: tetrabenazine
Date of Approval: August 15, 2008
Company: Prestwick Pharmaceuticals, Inc.

Treatment for: Huntington's Chorea

FDA Approves Xenazine

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The U.S. Food and Drug Administration (FDA) has approved Xenazine (tetrabenazine) for the treatment of chorea associated with Huntington's disease (HD).

A double-blind, placebo-controlled, Phase 3 study found that Xenazine significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. Xenazine will be marketed under an FDA-approved Risk Evaluation and Mitigation Strategy to decrease the risk of depression and suicidal ideation that may be associated with the drug, and are often pre-existing conditions in Huntington's disease patients.

About Huntington's Disease

Affecting an estimated 30,000 Americans, HD is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes and is ultimately a fatal condition. Chorea is the most common symptom, affecting approximately 90% of HD patients, and is characterized by excessive, involuntary and repetitive movements, which are the most visible and dangerous manifestations of HD and interfere with patients' abilities to perform activities of daily living, including dressing, bathing and caring for themselves.

About Xenazine (tetrabenazine)

Xenazine is indicated for the treatment of chorea associated with Huntington's disease. A selective and reversible centrally-acting dopamine depleting drug, Xenazine works by inhibiting a molecule known as VMAT2 (vesicular monoamine transporter 2). Xenazine has been designated as an "orphan drug" by the FDA and will have seven years market exclusivity in the United States.

Important Safety Information

The most frequent and serious adverse events seen with tetrabenazine are somnolence/sedation and insomnia, respectively. Adverse events reported with Xenazine included depression, akathisia, parkinsonism and sedation. Xenazine's effects are largely reversible and manageable.

Important Information for Patients

Patients and their families should be told that Xenazine may increase the risk of patients considering or attempting suicide. Patients and their families should be encouraged to be alert to the emergence of suicidal ideation and should report it immediately to the patient’s physician.

Patients and their families should be told that Xenazine may cause depression or may worsen pre-existing depression. They should be encouraged to be alert to the emergence of sadness, worsening of depression, withdrawal, insomnia, irritability, hostility (aggressiveness), akathisia (psychomotor restlessness), anxiety, agitation, or panic attacks and should report such symptoms promptly to the patient’s physician.

Patients and their families should be told that the dose of Xenazine will be titrated up slowly to the dose that is best for each patient. Sedation, akathisia, parkinsonism, depression, and difficulty swallowing may occur.

Such symptoms should be promptly reported to the physician and may require dose reduction or tetrabenazine discontinuation.

Patients should be told that Xenazine may induce sedation and somnolence and may impair the ability to perform tasks that require complex motor and mental skills. Patients should be advised that until they learn how they respond to Xenazine they should be careful doing activities that require them to be alert, such as driving a car or operating machinery.

Patients and their families should be advised that alcohol may potentiate the sedation induced by Xenazine.

Patients and their families should be advised to notify the physician if the patient becomes pregnant or intends to become pregnant during Xenazine therapy, or is breast-feeding or intending to breast-feed an infant during therapy.

Patients and their families should be advised to notify the physician of all medications the patient is taking and to consult with the physician before starting any new medications.

Xenazine Consumer Information

This leaflet does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking Xenazine, ask your doctor or pharmacist.

What is Xenazine used for?

Xenazine is used for the treatment of chorea associated with Huntington’s disease.

Before taking Xenazine

Xenazine is not suitable for everyone.

Do not take Xenazine if:

You are allergic to tetrabenazine or any other ingredients in Xenazine Tablets.
You are taking medicine containing reserpine.
You are taking medicine containing levodopa (which is used to treat Parkinson’s disease).
You are being treated for Parkinson’s disease.
You are being treated for depression.
You are taking central nervous system stimulants or depressants (including alcohol).
You are pregnant or breastfeeding.

Before you start to use Xenazine:

Tell your doctor if you have any allergies.
Tell your doctor if you are pregnant or intend to become pregnant or to breastfeed.
Tell your doctor if you suffer from any depression or Parkinson’s disease.
Tell your doctor if you have kidney or liver disease.

What other drugs will affect Xenazine?

Tell your doctor if you are taking medicines containing reserpine, medicine for lowering blood pressure or any other medicines.

How should I take Xenazine?

Take Xenazine exactly as directed on the label, or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You should not normally stop taking Xenazine unless your doctor tells you to.

If you feel unwell during your course of treatment, tell your doctor.

What happens if I miss a dose?

If you forget to take a dose of Xenazine Tablets, leave out that dose completely. Take your next dose at the normal time it is due.

Do not take a double dose to make up for the dose that you missed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Xenazine Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenazine. Like all medicines, Xenazine may have some side effects.

Side effects of Xenazine can include:

Sleepiness and drowsiness
Depression
Uncontrollable movements of the hands, arms, legs and head (similar to those in Parkinson’s disease)
Digestive problems
Lowering of blood pressure
Feeling nervous or anxious
Trouble sleeping

If these events persist, you should consult your doctor.

Tell your doctor immediately if you notice any of the following:

Difficulty in swallowing
Choking attacks
Stiffness or tightness in the arms or legs
Confusion or having thoughts of irrational ideas not shared by others

Xenazine may affect your ability to drive or operate machinery. Be careful driving or operating machinery until you know how Xenazine affects you. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.