Treatment for Chorea Associated with Huntington’s Disease

XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease.

Other Patient Support Programs Terms and Conditions

Informational support provided through the Lundbeck Xenazine Information Center (“Informational Support”) is available for eligible Xenazine patients only. Informational Support should not replace conversations between patients and their health care providers or their office staff, is not insurance or a guarantee of coverage or assistance, and has no independent value.

Patients are eligible for Informational Support if they have a valid prescription for Xenazine and a request is submitted to the Xenazine Information Center using a completed Xenazine Treatment Form. Informational Support includes insurance coverage information related to Xenazine and, depending on patient eligibility, information regarding other Lundbeck patient support programs. Separate applications may be required for Lundbeck programs to determine patient eligibility.

There may be other ways for patients to obtain assistance verifying insurance coverage for, and/or affording the cost of Xenazine. Questions regarding other possible sources of patient support should be directed to the patient’s health care provider.

There is no purchase requirement associated with Informational Support. Informational Support is only provided in the USA where allowed by law. Informational Support 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. Lundbeck reserves the right to rescind, revoke, or amend Informational Support without notice. Questions regarding Informational Support that may be available to a patient and opt-out requests should be directed to the Xenazine Information Center: Monday-Friday, 8:00 a.m. to 6:00 p.m. ET. 1-888-882-6013.

Terms and Conditions for the Xenazine Copay Assistance Program

Terms and Conditions: Only commercially insured patients age 17 and older whose insurance policy provides coverage for Xenazine^® (tetrabenazine) and 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 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 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. If the patient’s total out-of-pocket pharmacy bill exceeds the cap established by Lundbeck, the patient will be responsible for the additional balance. 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

WARNING: DEPRESSION AND SUICIDALITY

See full prescribing information for complete boxed warning.

Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease.
Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of XENAZINE.
Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior.
Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician.
Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation.
XENAZINE is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.

IMPORTANT SAFETY INFORMATION

WARNING: DEPRESSION AND SUICIDALITY

See full prescribing information for complete boxed warning.

Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease.
Balance risks of depression and suicidality with the clinical need for control of chorea when considering the use of XENAZINE.
Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior.
Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician.
Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation.
XENAZINE is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.

XENAZINE is also contraindicated in patients with hepatic impairment and patients taking monoamine oxidase inhibitors (MAOIs), reserpine, and deutetrabenazine or valbenazine. XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. XENAZINE should not be used concomitantly with reserpine, and at least 20 days should elapse after stopping reserpine before starting XENAZINE.
Prescribers should periodically re-evaluate the need for XENAZINE in their patients by assessing the effect on chorea and possible adverse effects, including depression and suicidality, cognitive decline, parkinsonism, dysphagia, sedation/somnolence, akathisia, restlessness, and disability.
XENAZINE should be titrated slowly over several weeks and individualized for each patient. Before a dose >50 mg/day is administered, determine a patient’s CYP2D6 metabolizer status. Individualize doses according to a patient’s status. Do not exceed a dose of 50 mg/day or 25 mg/dose in poor metabolizers and when administering XENAZINE with strong CYP2D6 inhibitors. XENAZINE therapy should be re-titrated if there is a treatment interruption of >5 days.
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with XENAZINE. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. The management of NMS should include immediate discontinuation of XENAZINE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. Recurrence of NMS has been reported with resumption of drug therapy.
XENAZINE may increase the risk of akathisia, restlessness, and agitation and can also cause other serious adverse reactions, including parkinsonism. These adverse reactions may require a dose reduction or discontinuation of XENAZINE.
XENAZINE may induce sedation/somnolence, which may impair a patient’s ability to drive or operate dangerous machinery. Concomitant use of alcohol or other sedating drugs can worsen sedation/somnolence. In some patients, sedation occurred at doses that were lower than recommended doses.
XENAZINE causes a small prolongation of QTc (about 8 msec) and should not be used in combination with drugs known to prolong QTc (which in certain circumstances can lead to torsades de pointes and/or sudden death), in patients with congenital long QT syndrome, and in patients with a history of cardiac arrhythmias.
The risk of Parkinsonism, NMS, and akathisia may be increased by concomitant use of XENAZINE and dopamine antagonists or antipsychotics.
Monitoring of vital signs on standing should be considered in patients who are vulnerable to hypotension.
XENAZINE elevates serum prolactin concentrations. If symptomatic hyperprolactinemia is suspected, conduct appropriate laboratory testing and consider discontinuing XENAZINE.
Some adverse events, such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety, or sedation, may be dose-dependent. Stop titration and reduce the dose of XENAZINE if observed. If the adverse reaction does not resolve, consider withdrawing XENAZINE or initiating other specific treatment.
The most commonly reported adverse reactions with XENAZINE (>10% and at least 5% greater than placebo) were sedation/somnolence (31% vs 3%), fatigue (22% vs 13%), insomnia (22% vs 0%), depression (19% vs 0%), akathisia (19% vs 0%), anxiety/anxiety aggravated (15% vs 3%), and nausea (13% vs 7%).

For more information, please see the Medication Guide and full Prescribing Information, including Boxed Warning for depression and suicidality, 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.