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.

Xenazine Copay Assistance Program Terms and Conditions

Terms and Conditions: Only commercially insured patients age 17 and older who are not reimbursed for the entire cost of the prescription are eligible for the copay assistance (the "Offer"). Patients are not eligible for the Offer if they are self-pay or if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal health care programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or TRICARE. In addition, patients may not use the Offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

The Offer is valid only for use with a valid prescription for Xenazine® (tetrabenazine) at the time the prescription is filled by the pharmacist and dispensed to the patient. The Offer applies only to prescriptions filled before the program expires or terminates. The copay prescriptions shall not be submitted for reimbursement to any private or public third-party payer, including Medicaid or Medicare, or any other similar federal or state healthcare program. Patients are responsible for complying with any obligations or requirements imposed by their insurance plans.

The Offer is not transferable. The selling, purchasing, trading, or counterfeiting of the Offer is prohibited by law. The Offer has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription.

Lundbeck reserves the right to rescind, revoke, terminate or amend the Offer without notice. The Offer is intended to comply with all applicable laws and regulations, including, without limitation, the federal Anti-Kickback Statute, its implementing regulations, and related guidance interpreting the federal Anti-Kickback Statute. The Offer is not health insurance. The Offer is valid only in the USA where allowed by law. There is no future purchase requirement associated with the Offer. Patient questions and requests to discontinue participation in the program can be directed to 1-888-882-6013 (8:00 am-6:00 pm ET, Monday through Friday).

Eligible commercially insured patients age 17 and older with a valid Xenazine prescription may participate in this program. Patients must pay at least $10 for each 30-day prescription. A maximum benefit limit may also apply; patients should confirm their out-of-pocket cost with their pharmacy at the time the pharmacy calls to dispense the prescription. By participating in the Copay Assistance program, the patient acknowledges and agrees that he/she is eligible to participate and that he/she understands and agrees to comply with the General and Copay Assistance Terms and Conditions.

To the Pharmacist:

  • Submit transaction to McKesson Corporation using BIN #610524.
  • Input card information as secondary coverage and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transaction response.
  • Acceptance of this card and your submission of claims are subject to the LoyaltyScript® program. Terms and Conditions posted at www.mckesson.com/mprstnc.
  • For questions regarding claim transmission call the LoyaltyScript® program at 1-800-657-7613 (8:00 am-8:00 pm ET, Monday through Friday).
  • For questions regarding patient eligibility or other issues, call the Xenazine Information Center at 1-888-882-6013 (8:00 am-6:00 pm ET, Monday through Friday).
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 (MAOIs) 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 or plan to become pregnant, breast-feeding, have breast cancer or a history of breast cancer, or have heart disease or an irregular heartbeat.
  • Tell your doctor about all the medicines you take. Do not start any new medicines while taking XENAZINE without talking to your doctor first.
  • Take XENAZINE exactly as prescribed by your doctor. 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.
  • The risk of side effects, such as irregular heartbeat, parkinsonism, NMS, and restlessness (akathisia), may be increased when using XENAZINE with other drugs (e.g., dopamine antagonists or antipsychotics).
  • 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? 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 Medication Guide; full Prescribing Information, including Boxed Warning for risks from concomitant use with opioids; and Instructions for Use.

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.

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 (MAOIs) 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 or plan to become pregnant, breast-feeding, have breast cancer or a history of breast cancer, or have heart disease or an irregular heartbeat.
  • Tell your doctor about all the medicines you take. Do not start any new medicines while taking XENAZINE without talking to your doctor first.
  • Take XENAZINE exactly as prescribed by your doctor. 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.
  • The risk of side effects, such as irregular heartbeat, parkinsonism, NMS, and restlessness (akathisia), may be increased when using XENAZINE with other drugs (e.g., dopamine antagonists or antipsychotics).
  • 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? 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.