Austedo

Austedo is a prescription medication used to treat chorea (uncontrolled movements) caused by Huntington's disease. Additionally, Austedo is used to treat tardive dyskinesia (involuntary, repetitive movements) in adults. Austedo belongs to a group of drugs called VMAT2 inhibitors. These work in the brain to change how your nervous system and muscles function. 

This medication comes in tablet form and is taken once daily for Huntington's disease and 2 times a day for tardive dyskinesia. Austedo should be taken with food at the same time every day.

Do not chew, divide, or break Austedo tablets. Swallow Austedo tablets whole.

Common side effects of this medication in Huntington's disease patients include sleepiness, diarrhea, dry mouth, and fatigue. 

Common side effects of Austedo in tardive dyskinesia patients include common cold and insomnia. 

Austedo can also cause drowsiness. Do not drive or operate heavy machinery until you know how Austedo affects you.

Austedo is a prescription medicine that is used to treat:

• the involuntary movements (chorea) of Huntington’s disease. Austedo does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.
• movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Austedo. See the “Austedo Precautions” section.

Huntington's Patients: 

Common side effects include:

• sleepiness
• diarrhea
• dry mouth
• fatigue
• urinary track infections
• insomnia

Tardive Dyskinesia Patients:

Common side effects include:

• common cold 
• insomnia
• depression
• restlessness

This is not a complete list of Austedo side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

Medications that block the enzyme called CYP2D6 such as: 

•  quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)

Medications that can cause an arrhythmia called Torsades des Point such as:

• certain anti-arrhythmia medications including procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
• certain fluoroquinolone antibiotics including levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
• certain macrolide antibiotics including clarithromycin (Biaxin), erythromycin (EES, others)
• certain azole antifungals including ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
• certain antidepressants including amitriptyline, desipramine (Norpramin), imipramine (Tofranil), doxepin (Silenor), fluoxetine (Prozac, Sarafem, Symbyax), sertraline (Zoloft), venlafaxine (Effexor XR)
• certain antipsychotics including haloperidol (Haldol), droperidol (Inapsine), quetiapine (Seroquel XR), thioridazine, ziprasidone (Geodon)
• and other medications including cisapride, sumatriptan (Treximet, Imitrex, Alsuma, Zecuity), zolmitriptan (Zomig, arsenic trioxide (Trisenox), dolasetron (Anzemet), and methadone (Methadone, Dolophine

Reserpine. This medication works similarly to Austedo, so taking them together could cause overdose symtoms and cause problems in the central nervous system. 

Medications that block an enzyme called monoamine oxidase such as:

• isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)

Antipsychotics medications such as:

• paliperidone (Invega), lurasidone (Latuda), olanzapine (Zyprexa), aripiprazole (Abilify), asenapine (Saphris), iloperidone (Fanapt), haloperidol (Haldol), prochlorperazine (Compazine), chlorpromazine (Thorazine), clozapine (Clozaril), risperidone (Risperdal), quetiapine (Seroquel), and ziprasidone (Geodon)

Alcohol and other sedating medications such as: 

• barbiturate medications including butalbital, pentobarbital (Nembutal), phenobarbital (Luminal)
• benzodiazepine medications including clonazepam (Klonopin), diazepam (Diastat), lorazepam (Ativan), midazolam (Versed), alprazolam (Xanax), temazepam (Restoril)
• hypnotic medications including eszopiclone (Lunesta), zeleplon (Sonata), zolpidem (Ambien)
• first generation antihistamine medications including diphenhydramine (Benedryl), doxylamine (Diclectin), promethazine (Phenergan), hydroxyzine (Vistaril), chlorpheniramine (Chlor-Trimeton)
• muscle relaxant medications including baclofen (Lioresal), carisoprodol (Somadril), cyclobenzaprine (Flexeril), methocarbamol (Robaxin), tizanidine (Zanaflex), gabapentin (Neurontin), pregabalin (Lyrica)
• opioid pain relieving medications including tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)
• antidepressant medications including amitriptyline (Elavil), trazodone (Oleptro), mirtazapine (Remeron), doxepin (Sinequan), nortriptyline (Pamelor), nefazodone (Serzone)
• antipsychotic medications including olanzepine (Zyprexa), clozapine (Clozaril), haloperidol (Haldol), fluphenazine (Prolixin), quetiapine (Seroquel), prochlorperazine (Compazine)

Tetrabenazine or valbenazine. Austedo should not be taken with these medications. 

This is not a complete list of Austedo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with all Austedo uses and include the following:

QT prolongation. This is a condition when changes in the electrical activity of your heart occur, causing irregular heartbeats that can be life threatening. Talk to your healthcare provider about other medicines you are taking before you start taking Austedo. Tell your healthcare provider right away if you have any signs or symptoms of QT prolongation:

• feeling faint
• lightheadedness
• dizziness
• feeling like your heart is beating irregularly or quickly

Neuroleptic Malignant Syndrome (NMS). A condition affects your body movements and can be life threatening. Talk to your healthcare providor right away if you have any signs or symptoms of NMS:

• increased reflexes
• muscle stiffness
• changes in mental status
• irregular pulse or blood pressure

Agitiation/Restlessness. Austedo can make you feel like you need to constantly be moving. May include rocking, marching, or crossing and uncrossing legs. 

Sedation. Austedo can make you feel more tired or dizzy. Do not operate a motor vehicle or machinery until you know how Austedo will affect you.

Hyperprolactinemia. Austedo can cause an increase in a hormone called prolactin and could lead to low levels of estrogen or osteoporosis. Keep all appointments with your doctor so you can monitor prolactin levels. 

Eye problems. Austedo can bind to tissue that contains melanin, typically found in the eyes, and cause toxic effects. You should continue periodic eye exams while taking Austedo. 

Huntington's Disease Patients Only:

Depression/Suicidal thoughts. Contact your provider right away if you see any of the following symptoms of depression or suicide:

• severe sadness
• suidcide thoughts
• changes in behavior

Worsening Huntington's symptoms. If you have an increase in Huntington's symptoms contact your doctor right away and discontinue Austedo: 

• worsening mood
• decrease in cognition (mental capacity)
• increased muscle rigidity 

Parkinson-like symptoms. Austedo can cause a secondary parkinson's disease in Huntington's patients. Your doctor may decrease your dose or stop Austedo completely if parkinson's is confirmed. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Austedo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Austedo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Austedo or to any of its ingredients
• have emotional or mental problems (for example, depression, nervousness, anxiety, anger, agitation, psychosis, previous suicidal thoughts or suicide attempts)
• have liver disease
• have an irregular heartbeat
• have low levels of potassium or magnesium in your blood
• have or have had breast cancer
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given Austedo, and there was no clear effect on the baby. 

No well-controlled studies have been done in humans. Therefore, Austedo may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Austedo crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of Austedo. Your doctor and you will decide if the benefits outweigh the risk of using Austedo.

Take Austedo exactly as your healthcare provider tells you to take it.

• Take Austedo by mouth and with food.
• Swallow Austedo tablets whole with water. Do not chew, crush, or break Austedo tablets before swallowing. If you cannot swallow Austedo tablets whole, tell your healthcare provider. You may need a different medicine.
• If your dose of Austedo is 12 mg or more each day, take Austedo tablets 2 times a day in equal doses with food.
• Your healthcare provider will increase your dose of Austedo each week for several weeks, until you and your healthcare provider will find the right dose for you.
• Tell your healthcare provider if you stop taking Austedo for more than 1 week. Do not take another dose until you talk to your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

Huntington's Disease

The recommended starting dose of Austedo for the treatment of Huntington's disease is 6 mg (1 tablet) once per day. Your doctor might increase your dose by 6 mg every week depending on symtom control. The max dose of Austedo is 48 mg (8 tablets) per day. 

Tardive Dyskinsia

The recommended starting dose of Austedo for the treatment of Huntington's disease is 6 mg (1 tablet) 2 times per day. Your doctor might increase your dose by 6 mg every week depending on symptom control. The max dose of Austedo is 48 mg (8 tablets) per day. 

If you take too much Austedo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

Store Austedo at room temperature, protect from light. Keep Austedo and all medicines out of the reach of children. 

Austedo can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Closely monitor for new or worsening depression, suicidality, or unusual changes in behavior. Patients, caregivers, and families should be informed of the risk of depression and suicidality and should report behaviors of concern promptly to the treating doctor. 

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. Austedo is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.