How to Prescribe Xenazine® (tetrabenazine)
Xenazine® (tetrabenazine) is not available through a local pharmacy or mail-order pharmacy. Instead,
the prescription will be coordinated through the Xenazine Information Center (XIC)
and will be mailed to your patient by a specialty pharmacy. The XIC is available
toll-free for all healthcare providers as well as patients and caregivers at 1-888-882-6013.
Find out more about Xenazine Safety Profile.
Before prescribing Xenazine, please review the
Important Safety Information, including Boxed Warning.
Please follow these steps to successfully prescribe Xenazine for your patients:
Step 1: Complete the Treatment Form
You and the patient or caregiver complete, sign and FAX the
Xenazine Treatment Form to the Xenazine Information Center (XIC) at 1-866-341-5601
(fax number). This form will serve as the patient’s initial prescription for Xenazine.
Download a Healthcare Professional Guide for prescribing Xenazine and start the conversation with patients.
Step 2: Insurance coverage, co-pay verification & co-pay assistance
Upon receipt of the Xenazine Treatment Form, the XIC helps verify the patient's insurance information and co-pay amount.
New and existing Xenazine patients who have commercial insurance coverage for Xenazine are qualified for this program, which will cover 100% of their Xenazine co-payments! There's no paperwork required. Patients are not eligible for this program if his or her commercial insurance covers the entire cost of the prescription or have a state or federal coverage. Eligibility will be determined on a calendar year basis.
Patients with state or federal insurance coverage, such as Medicare, Medicaid, or TRICARE, may qualify for financial assistance with their co-payments from one or more charitable assistance programs.
Patients who do not qualify for any charitable co-pay assistance programs will receive Xenazine from Lundbeck free of charge; patient's insurance or health coverage will not be billed for the Xenazine provided.
- Encourage your patients to call the XIC to find out what co-pay assistance they're eligible for.
While your patient's insurance coverage is being verified, their medication will be mailed within five business days after the XIC receives the completed treatment form.* If coverage is denied, the XIC works with your office and the patient's insurer to appeal, where permitted.
Step 3: Medication sent from a Specialty Pharmacy
Your patient will be assigned a specialty pharmacy that will collect co-payments,
provide refill reminders, and answer questions as appropriate. All filled Xenazine
prescriptions can be mailed to your office or directly to your patient, as requested
on the treatment form.
Once your patient begins taking the medication as prescribed, it is important
that you arrange follow-up discussions. Conversations with both the patient and
the caregiver are especially helpful during the titration phase.
Please make sure to ask your patient to read the Medication Guide each time he or she
refill their prescription, as there may be updated information.
* Program not available in all states.
- "FDA Approves First Drug for Treatment of Chorea in Huntington's Disease", FDA News Release, August 15, 2008: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116936.htm. Updated April 15, 2013. Accessed August 17, 2015.
XENAZINE® (tetrabenazine) Tablets
Indications and Usage:
XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease.
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 who have impaired hepatic function or are taking monoamine oxidase inhibitors (MAOIs) or reserpine. XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. 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 beneficial effect on chorea and possible adverse effects, including worsening mood, cognition, rigidity, and functional capacity. XENAZINE should be titrated slowly over several weeks for a dose that is appropriate for each patient.
- Before a dose greater than 50 mg/day is administered, the patient's CYP2D6 metabolizer status should be determined. Do not exceed 50 mg/day or 25 mg/dose if XENAZINE is administered with a strong CYP2D6 inhibitor.
- XENAZINE therapy should be re-titrated if there is a treatment interruption of greater than 5 days, or a treatment interruption occurring due to a change in the patient's medical condition or concomitant medications.
- 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 and other drugs not essential to concurrent therapy.
- XENAZINE can also cause other serious side effects, including: akathisia, restlessness, agitation, parkinsonism, and sedation/somnolence. These side effects may require a dose reduction or discontinuation of XENAZINE. Monitoring of vital signs on standing should be considered in patients who are vulnerable to hypotension. Dysphagia has also been reported with use of XENAZINE; some cases of dysphagia were associated with aspiration pneumonia.
- QT prolongation–related arrhythmias have been reported with use of XENAZINE. XENAZINE 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, or in patients with a history of cardiac arrhythmias. A potentially irreversible syndrome of involuntary, dyskinetic movements called tardive dyskinesia (TD) may develop in patients treated with neuroleptic drugs. If signs and symptoms of TD appear in a patient treated with XENAZINE, drug discontinuation should be considered. The risk of parkinsonism, NMS, and akathisia may be increased by concomitant use of XENAZINE and dopamine antagonists or antipsychotics.
- XENAZINE elevates serum prolactin concentrations. XENAZINE may induce sedation/somnolence which may impair the ability to drive or operate dangerous machinery. Alcohol or other sedating drugs can worsen sedation/somnolence.
- Some adverse events, such as depression, fatigue, insomnia, sedation/somnolence, parkinsonism, and akathisia, may be dose-dependent. If the adverse effect does not resolve or decrease, consideration should be given to lowering or discontinuing XENAZINE. The most commonly reported adverse events with XENAZINE compared to placebo were sedation/somnolence (31% vs 3%), fatigue (22% vs 13%), insomnia (22% vs 0%), depression (19% vs 0%), akathisia (19% vs 0%), anxiety (15% vs 3%), and nausea (13% vs 7%).
For more information, please see the full Prescribing Information, including Boxed Warning, the Medication Guide or go to www.XENAZINEusa.com.
Xenazine is a registered trademark of Valeant International Bermuda or its affiliates.
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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.