Tetrabenazine, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat symptoms of Huntington’s disease. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: anti-chorea; MAO depleter

Generic and brand names: tetrabenazine, oral; Xenazine

What is this medicine used for?

This medicine is taken by mouth to treat the involuntary movements (chorea) of Huntington's disease.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Arrhythmia (heart rhythm problems) or prolonged QT interval (a serious electrical defect of the heart)
• Breast cancer
• Depression or thoughts of suicide
• Heart disease, heart failure, or heart attack
• Too little potassium or magnesium in your blood
• Liver or kidney problems
• Low blood pressure
• Parkinson’s disease
• Trouble swallowing

Do not take this medicine if you are taking an MAO inhibitor or reserpine. You may have serious side effects. Discuss this with your healthcare provider.

Tell your healthcare provider if you are currently taking any antidepressants or pain medicines.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without discussing with your healthcare provider.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Important: Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Your healthcare provider will slowly adjust your dose over several weeks. Do not take more or less or take it longer than prescribed. Taking too much can cause serious side effects. Do not stop taking this medicine without your healthcare provider's approval. If you have stopped taking the medicine for more than 5 days for any reason, do not take another dose until you talk to your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

If you have missed a dose, your symptoms may return or worsen in 12 to 18 hours after taking the last dose.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, dizziness, confusion, flushing, sweating, diarrhea, hallucinations, nausea, vomiting, weakness, fainting, odd eyeball movements, tremor, twitching, restlessness.

What should I watch out for?

Behavior changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as: more outgoing or aggressive behavior than normal, confusion, hallucinations, worsening of depression, or suicidal thoughts.

You will need to have blood tests regularly to see how this medicine affects you. Your healthcare provider will regularly check on your progress and dosage.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movements. Talk to your healthcare provider about this.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or confused. Contact your provider immediately if you have these symptoms.

This medicine may cause drowsiness and confusion. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol while taking this medicine. Do not take other medicines without your healthcare provider's approval. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Increase in unusual movements of body, depression or thoughts of suicide, extreme restlessness, seizures, high fever, severe muscle stiffness, confusion, increased coughing or trouble swallowing, fast or irregular heartbeat, severe dizziness or fainting, muscle spasms, twitching in the face and body, uncontrolled tongue or jaw movements, painful urination.

Other: Drowsiness, dizziness, tiredness, trouble sleeping, loss of balance, joint pain, mild shaking, nausea, nervousness, headache, loss of appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), miconazole (Monistat, Oravig), and terbinafine (Lamisil)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), imatinib (Gleevec), nilotinib (Tasigna), procarbazine (Matulane), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as delavirdine (Rescriptor) and ritonavir (Norvir)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• Rasagiline (Azilect)
• Reserpine (Do not take within 20 days of this medicine.)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.