Xenazine

Xenazine is a prescription medication used to treat chorea, a coordination disorder associated with Huntington's disease. Xenazine belongs to a group of drugs called VMAT inhibitors. These work to improve coordination through a mechanism that is currently not yet fully understood, but is believed to involve reducing the concentrations of certain chemicals in the body at nerve terminals, where messages travel from the brain to bring about bodily movements.

This medication comes in tablet form and is typically taken 1 to 3 times a day, with or without food.

Common side effects of Xenazine include depression, tiredness, anxiety, and nausea.

Xenazine can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Xenazine affects you.

Xenazine is a prescription medication used to treat chorea, a coordination disorder associated with Huntington's disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Lundbeck, LLC

Serious side effects have been reported with Xenazine. See the “Xenazine Precautions” section.

Common side effects of Xenazine include the following:

• drowsiness (sedation)
• insomnia
• depression
• tiredness (fatigue)
• restlessness
• nausea
• irritability
• anxiety
• dizzinesss

This is not a complete list of Xenazine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• cisapride
• dronedarone
• isocarboxazid
• linezolid
• phenelzine
• pimozide
• alcohol
• hlorpromazine
• haloperidol
• olanzapine
• risperidone
• thioridazine
• ziprasidone
• procarbazine
• rasagiline
• reserpine
• selegiline
• thioridazine
• toremifene
• tranylcypromine
• medications that are metabolized by CYP2D6 enzymes; If you are unsure if you are taking one of these medications, consult with your pharmacist
• medications that cause netral nervous system depression; If you are unsure if you are taking one of these medications, consult with your pharmacist
• medications that can affect your heart rhythm; If you are unsure if you are taking one of these medications, consult with your pharmacist

This is not a complete list of Xenazine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xenazine including the following:

• Worsening of chorea symptoms and/or progression of Huntington's disease. It can be difficult to determine if certain symptoms are side effects of Xenazine or a result of the progression of underlying Huntington's disease. For this reason, inform your physician of any changes in symptoms that you experience during your treatment with Xenazine.
• Depression and suicidality. People with Huntington's disease are already at increased risk for depression and suicidality and Xenazine further increases this risk. Users of Xenazine, their caregivers, and their families should be informed of these risks and instructed to report any behaviors of concern to the treating physician immediately. If any behaviors of concern develop, discontinue use of Xenazine immediately.
• Neuroleptic malignant syndrome (NMS). Neuroleptic malignant syndrome is a potentially fatal and complex symptom that can occur in people using Xenazine and other medications similar to Xenazine. Symptoms of neuroleptic malignant syndrome include:
  • sudden onset of fever
  • sudden onset of muscle rigidity
  • altered mental status
  • irregular pulse and/or heartbeat
  • excessive sweating

If you experience any of these symptoms, discontinue use of Xenazine and get medical attention immediately.

• Symptoms of Parkinson's disease. Xenazine can cause symptoms of Parkinson's disease. In a clinical trial, these symptoms were observed in 15% of people using Xenazine. While symptoms of Parkinson's disease can be difficult to discern from symptoms of chorea, if you believe you are experiencing symptoms of Parkinson's disease, consult with your physician.
• Difficulty swallowing. Medications similar to Xenazine have been known to cause difficulty swallowing. In one clinical trial, difficulty swallowing was observed in 4% of patients treated with Xenazine. If you experience difficulty swallowing while using Xenazine, consult with your physician.
• Abnormal heart rhythms. Xenazine is known to cause small alterations in normal heart rhythms. These alterations can be more pronounced in people with existing abnormal heart rhythms. Consult with your physician about your risk for developing abnormal heart rhythms while using Xenazine.
• Dizziness upon standing. In a clinical trial, dizziness upon standing occurred in 4% of patients treated with Xenazine. Dizziness upon standing can be dangerous and lead to fainting and injuries. If you experience dizziness upon standing while taking Xenazine, consult with your physician.

Xenazine can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Xenazine affects you.

Do not take Xenazine if you:

• are allergic to Xenazine or to any of its ingredients 
• have suicidal thoughts or behavior
• have untreated depression
• have liver disease
• are taking a monoamine oxidase inhibiting medication or have taken one within 14 days; if you are unsure if you are taking one of these medications, consult with your pharmacist
• are taking reserpine or have taken reserpine wihtin 20 days

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xenazine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xenazine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Xenazine or to any of its ingredients
• have liver problems
• drink alcohol
• have abnormal heart rhythms
• have a history of depression or any other mental disorders
• have suicidal thoughts or behaviors
• sweat excessively or are generally 'hot-natured'
• have Parkinson's disease
• have any medical conditions that cause difficulty swallowing
• have low blood pressure
• have hyperprolactinemia
• have any other medical disorders that impair movement and/or coordination
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Xenazine falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Xenazine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xenazine.

• Take Xenazine exactly as prescribed
• Xenazine comes in tablet form and is typically taken 1 to 3 times a day, with or without food
• During the course of your treatment with Xenazine, be alert to the emergence of any suicidal thinking or behavior, hostility, insomnia, anxiety, panic attacks, and/or depression and report all instances to your physician immediately
• Avoid use of alcohol with Xenazine
• If you stop taking Xenazine or miss a dose, involuntary movements may return or worsen
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xenazine at the same time

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose range of Xenazine for the treatment of chorea associated with Huntington's disease is 12.5 mg to 100 mg by mouth daily, in doses up to 37.5 mg at a time, taken one to three times per day.

If you take too much Xenazine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 25ºC (77ºF)
• Keep this and all medicines out of the reach of children

• Xenazine can increase the risk of depression, suicidal thoughts, and behavior (suicidality) in patients with Huntington's disease
• Anyone considering the use of Xenazine must balance the risks of depression and suicidality with the need for control of symptoms of chorea
• Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy
• Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician
• Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease
• Xenazine is contraindicated in patients who are actively suicidal and in patients with untreated or inadequately treated depression