Pronunciation:

du-tet-ra-BEN-a-zeen

Brand Names:

• Austedo

Dosage Forms:

• Tablet, Extended Release
• Tablet

Warnings:

Depression and Suicidality in Patients with Huntington's DiseaseDeutetrabenazine extended release tablets and deutetrabenazine tablets can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine extended release tablets or deutetrabenazine tablets must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. 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. Deutetrabenazine extended release tablets and deutetrabenazine tablets are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression .

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Deutetrabenazine is used to treat movement disorders, including tardive dyskinesia and chorea caused by Huntington's disease. Deutetrabenazine works in the central nervous system (CNS) to prevent the absorption of certain chemicals (eg, dopamine, serotonin, norepinephrine, histamine).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of deutetrabenazine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of deutetrabenazine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving deutetrabenazine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Linezolid
• Mesoridazine
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Pimozide
• Piperaquine
• Procarbazine
• Rasagiline
• Reserpine
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Tetrabenazine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Terbinafine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Akathisia (a movement disorder), including agitation and restlessness, history of or
• Depression, history of or
• Heart rhythm problems (eg, QT prolongation), history of or
• Suicidal thoughts or behavior—Use with caution. May make these conditions worse, especially in patients with Huntington's disease.

• Bradycardia (slow heartbeat) or
• Breast cancer, history of or
• Hypokalemia (low potassium levels in the blood) or
• Hypomagnesemia (low magnesium levels in the blood)—Use with caution. May increase risk for serious side effects.

• Depression, untreated or
• Liver disease or
• Suicidal thoughts or behavior, active—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet and the extended-release tablet whole with water. Do not crush, break, or chew it.

Take the tablet with food. You may take the extended-release tablet with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For tardive dyskinesia and chorea caused by Huntington's disease:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 12 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 48 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 12 milligrams (mg) per day taken in 2 divided doses (6 mg two times a day). Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 48 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you stop taking this medicine for more than 7 days, do not take another dose until you talk to your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.

Deutetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, especially if they have a condition called Huntington's disease. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within 14 days of each other. If you have questions, check with your doctor.

Do not take this medicine if you are also taking reserpine (Serpalan® or Renese®-R). Wait at least 20 days after stopping reserpine before starting deutetrabenazine. If you have questions, check with your doctor.

Do not take this medicine if you are also taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®). If your doctor plans to switch your treatment from tetrabenazine to deutetrabenazine, take your first dose of deutetrabenazine one day after your last dose of tetrabenazine. If you have questions, check with your doctor.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Check with your doctor right away if you have an inability to sit still, need to keep moving, or restlessness. These could be symptoms of a movement disorder called akathisia.

This medicine may cause parkinsonism (a movement disorder). Check with your doctor right away if you have difficulty swallowing, loss of balance control, mask-like face, shuffling walk, slowed movements, slurred speech, stiffness of the arms and legs, tic-like or jerky movements of the head, face, mouth, and neck, or trembling and shaking of the fingers and hands.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If the problem continues or worsens, check with your doctor.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

diarrhea

difficulty with breathing

difficulty with swallowing

discouragement

drowsiness

dry mouth

fear

feeling sad or empty

fever

headache

inability to sit still

irritability

lack of appetite

loss of balance control

loss of interest or pleasure

mask-like face

need to keep moving

nervousness

relaxed and calm feeling

restlessness

shuffling walk

sleepiness or unusual drowsiness

slow movement or reflexes

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

tiredness

trembling and shaking of the fingers and hands

trouble concentrating

trouble sleeping

trouble with balance

unusual tiredness or weakness

Less common

Agitation

dizziness

problems passing stools

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fixed position of the eye

inability to move the eyes

increased blinking or spasms of the eyelid

mood or mental changes

nausea

seeing, hearing, or feeling things that are not there

shakiness in the legs, arms, hands, or feet

sticking out of the tongue

sweating

trembling or shaking of the hands or feet

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bruising

large, flat, blue patches on the skin

Less common

Muscle aches

sore throat

stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.