Austedo

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).

• Austedo can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of Austedo 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. Austedo is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
• Austedo may prolong the QT interval, but the degree of QT prolongation is not clinically significant when Austedo is administered within the recommended dosage range. Austedo should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.
• Sleepiness (sedation) is a common side effect of Austedo. While taking Austedo, do not drive a car or operate dangerous machinery until you know how Austedo affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking Austedo may increase any sleepiness caused by Austedo.

Austedo can cause serious side effects in people with Huntington’s disease, including:

• depression
• suicidal thoughts
• suicidal actions

Do not start taking Austedo if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when Austedo is started and when the dose is changed.

Call your healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you:

• feel sad or have crying spells
• lose interest in seeing your friends or doing things you used to enjoy
• sleep a lot more or a lot less than usual
• feel unimportant
• feel guilty
• feel hopeless or helpless
• feel more irritable, angry, or aggressive than usual
• feel more or less hungry than usual or notice a big change in your body weight
• have trouble paying attention
• feel tired or sleepy all the time
• have thoughts about hurting yourself or ending your life

Austedo can cause serious side effects, including:

• Irregular heartbeat (QT prolongation). Austedo increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking Austedo with certain medicines may increase this chance.
  • If you are at risk of QT prolongation, your healthcare provider should check your heart before and after increasing your Austedo dose above 24 mg a day.
• Neuroleptic Malignant Syndrome (NMS). Call your healthcare provider right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause:
• high fever
• stiff muscles
• problems thinking
• very fast or uneven heartbeat
• increased sweating
• Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
• Parkinsonism in people with Huntington’s disease. Symptoms of parkinsonism include: slight shaking, body stiffness, trouble moving, or keeping your balance.

The most common side effects of Austedo in people with Huntington’s disease include:

• sleepiness (sedation)
• tiredness
• diarrhea
• dry mouth

The most common side effects of Austedo in people with tardive dyskinesia include:

• inflammation of the nose and throat (nasopharyngitis)
• problems sleeping (insomnia)

These are not all the possible side effects of Austedo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The dose of Austedo is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor), the recommended starting dosage of Austedo is 12 mg per day (6 mg twice daily) for patients with Huntington’s disease or tardive dyskinesia.

• The dose of Austedo may be increased at weekly intervals in increments of 6 mg per day based on reduction of chorea or tardive dyskinesia and tolerability, up to a maximum recommended daily dosage of 48 mg.
• Administer total daily dosages of 12 mg or above in two divided doses.
• Administer Austedo with food. • Swallow Austedo whole. Do not chew, crush, or break tablets.

It is not known if Austedo is safe and effective in children.

Who should not take Austedo?

Do not take Austedo if you:

• have Huntington's disease and are depressed or have thoughts of suicide. 
• have liver problems.
• are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking Austedo. Do not start Austedo if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.
• are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan and Renese-R) with Austedo. If your healthcare provider plans to switch you from taking reserpine to Austedo, you must wait at least 20 days after your last dose of reserpine before you start taking Austedo.
• are taking tetrabenazine (Xenazine). If your healthcare provider plans to switch you from tetrabenazine (Xenazine) to Austedo, take your first dose of Austedo on the day after your last dose of tetrabenazine (Xenazine).
• are taking valbenazine (Ingrezza).

Before taking Austedo, tell your healthcare provider about all of your medical conditions, including if you:

• 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 heart rhythm or heartbeat (QT prolongation, cardiac arrhythmia) or a heart problem called congenital long QT syndrome.
• have low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• have breast cancer or a history of breast cancer.
• are pregnant or plan to become pregnant. It is not known if Austedo can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Austedo passes into breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Austedo with certain other medicines may cause side effects. Do not start any new medicines while taking Austedo without talking to your healthcare provider first.