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deutetrabenazine (Oral route)

du-tet-ra-BEN-a-zeen

Oral route(Tablet)

Deutetrabenazine can increase risk of depression, suicidality, and suicidal ideation. Close monitoring and counseling of patient, caregivers, and family members is necessary, especially because of increased risk inherent to Huntington disease. Use is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression .

Commonly used brand name(s)

In the U.S.

  • Austedo

Available Dosage Forms:

  • Tablet

Therapeutic Class: Central Nervous System Agent

Uses For deutetrabenazine

Deutetrabenazine is used to treat chorea (a movement disorder) that is caused by Huntington disease. Deutetrabenazine works in the central nervous system (CNS) to prevent the absorption of certain chemicals (such as dopamine and serotonin).

deutetrabenazine is available only with your doctor's prescription.

Before Using deutetrabenazine

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 deutetrabenazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to deutetrabenazine 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.

Pediatric

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.

Geriatric

Although appropriate studies on the relationship of age to the effects of deutetrabenazine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. 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.

Interactions with 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 deutetrabenazine, 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 deutetrabenazine 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.

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

Using deutetrabenazine 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.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Bupropion
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Terbinafine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

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 deutetrabenazine. 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.
  • Bradycardia (slow heartbeat) or
  • Breast cancer, history of—Use with caution. May increase risk of 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 deutetrabenazine

Take deutetrabenazine 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.

deutetrabenazine should be taken with food.

Dosing

The dose of deutetrabenazine 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 deutetrabenazine. 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 oral dosage form (tablets):
    • For chorea:
      • Adults—At first, 6 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 48 mg per day. If your dose is 12 mg or more per day, take the tablets 2 times a day in equal doses.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of deutetrabenazine, 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 deutetrabenazine 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 deutetrabenazine

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. If you or your caregiver notice any of these side effects, tell your doctor right away.

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

Do not take deutetrabenazine 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 deutetrabenazine if you are also taking tetrabenazine (Xenazine®). Take deutetrabenazine one day after stopping tetrabenazine. If you have questions, check with your doctor.

Check with your doctor right away if you have more than one of these symptoms while taking deutetrabenazine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, 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.

deutetrabenazine 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.

deutetrabenazine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to deutetrabenazine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think well.

Make sure your doctor knows if you are using amiodarone (Cordarone®), chlorpromazine (Thorazine®), moxifloxacin (Avelox®), procainamide (Pronestyl®), quinidine, sotalol (Betapase®), thioridazine (Mellaril®), or ziprasidone (Geodon®). Using any of these medicines together with deutetrabenazine may cause serious side effects.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

deutetrabenazine 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 deutetrabenazine. Check with your doctor before taking any of the above while you are using deutetrabenazine.

deutetrabenazine Side Effects

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 or nervousness
  • 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
  • relaxed and calm
  • 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
  • Dizziness
  • problems passing stools

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

Symptoms of overdose
  • Blurred vision
  • confusion
  • diarrhea
  • 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 and vomiting
  • 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

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, or patches in the skin

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.

Side Effects (complete list)

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