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Prescribing Information

Xenazine is available only through Specialty Pharmacies because of factors that relate to its orphan drug status and the need to provide appropriate education on the Risk Evaluation & Mitigation Strategy (REMS) program. To help manage the prescription process, the Xenazine Information Center (XIC) is available for all healthcare providers as well as patients and caregivers.

Before prescribing Xenazine for your patient, make sure you request the Xenazine Step-by-Step Patient Kit and review it with your patient and their caregiver. The Kit includes the following informational materials:

What You Need to Know About Xenazine (tetrabenazine)
Patient/Caregiver Counseling Guide
Xenazine Medication Guide
Initial Dosing Plan

The kits are available through your local Lundbeck Inc. sales representative or through the Xenazine Information Center (1-888-882-6013).

How to Prescribe Xenazine

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 1-866-882-6013. This form will serve as the patient’s initial prescription for Xenazine.

Step 2: Insurance Verification

The XIC will confirm your patient’s insurance coverage. Once verified, your patient’s prescription will be sent to a Specialty Pharmacy. A comprehensive patient assistance program is available for eligible patients.

Step 3: Medication sent from a Specialty Pharmacy

The Specialty Pharmacy will collect co-payments, fill and send the patient’s Xenazine prescription, provide refill reminders, and answer questions as appropriate. All Xenazine prescriptions will be mailed to your office or directly to your patient, as requested on the treatment form. In some cases, it may take some time to complete the benefits investigation, so please be patient during this process.

Once your patient begins taking their medication as prescribed, it is important that you arrange follow up discussions to ensure that everything is going well. 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 every time they refill their prescription, as there may be updated information.

XENAZINE® (tetrabenazine) Tablets

Indications and Usage:

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

Important Safety Information:

DEPRESSION AND SUICIDALITY

XENAZINE can increase the risk of depression and 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 clinical need for control of choreiform movements. 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.

Xenazine is also contraindicated in patients who have impaired hepatic function or are taking monoamine oxidase inhibitors or reserpine. At least 20 days should elapse after stopping reserpine before starting Xenazine.

The need for therapy should be evaluated on an ongoing basis with the patient’s doctor. Xenazine should be titrated slowly over several weeks for a dose that is appropriate for each patient. Before a dose greater than 50 mg is administered, the patient’s CYP2D6 metabolizer status should be determined.

Neuroleptic malignant syndrome (NMS), akathisia, agitation, parkinsonism, dysphagia, and 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. Adverse reactions associated with Xenazine, such as QTc prolongation, NMS, and extrapyramidal disorders, may be exaggerated by concomitant use of dopamine antagonists.

Xenazine elevates serum prolactin concentrations. Xenazine may induce sedation and somnolence (sleepiness or drowsiness) and may impair the ability to drive or operate dangerous machinery.

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 Full Prescribing Information, including Boxed Warning.

®Xenazine is a registered trademark of Biovail Laboratories International (Barbados) S.R.L.

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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.