Question 1

What is Austedo?

Accepted Answer

Austedo contains the active ingredient deutetrabenazine and belongs to a class of medications known as vesicular monoamine transporter 2 (VMAT2) inhibitors. This medication functions by decreasing the amount of certain natural substances in the brain that are involved in nerve and muscle function.

By modulating these chemical messengers, the drug helps to manage abnormal, uncontrollable body movements.

Question 2

What is Austedo used for?

Accepted Answer

Austedo is used to treat chorea associated with Huntington disease and tardive dyskinesia .

Question 3

How does Austedo work?

Accepted Answer

Mechanism of Action

Austedo is classified as a vesicular monoamine transporter 2 (VMAT2) inhibitor. It targets a specific protein in the brain that is responsible for storing and releasing chemical messengers, particularly dopamine.

Dopamine plays a key role in how the brain sends signals to control physical movements. In conditions such as Huntington's disease chorea and tardive dyskinesia, these signals can become overactive, leading to uncontrollable or jerky movements. Austedo works by:

Blocking the VMAT2 protein: This prevents the protein from moving dopamine into the areas of the nerve cells where it is stored for release.

Reducing dopamine levels: By limiting the amount of dopamine available at the nerve endings, the medication helps dampen the overactive signals that cause involuntary movements.

While the exact way the drug improves movement disorders is not fully understood, it is believed that this reduction in dopamine activity is the primary reason for its effectiveness.

The Role of Deuterium

Austedo is a modified version of an older medication called tetrabenazine. It contains deuterium, a naturally occurring form of hydrogen. This structural change causes the body to break down the medication more slowly, which allows for more stable levels of the drug in the body over time.

Question 4

What are the active ingredients in Austedo?

Accepted Answer

The active ingredient in Austedo is deutetrabenazine .

Question 5

What are the side effects of Austedo?

Accepted Answer

Common side effects of Austedo may include:

sleepiness

diarrhea

dry mouth

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Austedo?

Accepted Answer

Austedo belongs to the vesicular monoamine transporter 2 (VMAT2) inhibitor drug class.

Question 7

What is the dosage of Austedo and how do I take it?

Accepted Answer

How to Take Austedo

Austedo is available as tablets that are taken by mouth. It is important to take this medication with food. The tablets should be swallowed whole; do not crush, chew, or break them before swallowing.

Dosing Schedule

The frequency of your doses depends on the specific type of tablet prescribed. Some versions are taken once daily, while others are taken twice daily. Your healthcare provider will typically start you on a low dose and gradually increase it over several weeks to find the amount that works best for you.

Missed Doses

If you miss a dose of Austedo, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time to make up for a missed one.

Discontinuing Treatment

If you stop taking Austedo for several days, your healthcare provider may need to restart the medication at a lower dose and gradually increase it again. Do not stop taking this medication without consulting your doctor.

Question 8

Is Austedo safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

It is currently unknown if Austedo will cause harm to an unborn baby, as there are no adequate and well-controlled studies in pregnant women. If you are pregnant or planning to become pregnant, you should inform your healthcare provider to determine if the benefits of the medication outweigh the potential risks.

Breastfeeding

It is not known whether Austedo passes into human breast milk or how it might affect a nursing infant. Because of the potential for serious adverse reactions in a breastfed child, the following precautions are generally recommended:

Breastfeeding is not recommended during treatment with Austedo.

Avoid breastfeeding for at least 14 days after taking the final dose of the medication.

The decision to breastfeed while taking this medication should involve a discussion with a healthcare professional regarding the clinical need for the drug and the health benefits of breastfeeding for the infant.

Question 9

What forms and strengths does Austedo come in?

Accepted Answer

Austedo is provided in the following oral dosage forms:

Tablets: An immediate-release formulation.

Extended-release tablets: A formulation designed to release the medication over a longer period, marketed as Austedo XR.

Question 10

What is the FDA approval status of Austedo?

Accepted Answer

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Austedo in April 2017. It was the first deuterated drug product approved by the FDA. Initially indicated for the treatment of chorea associated with Huntington’s disease, its approval was expanded in August 2017 to include the treatment of tardive dyskinesia in adults. In February 2023, the FDA approved a once-daily extended-release formulation known as Austedo XR.

Boxed Warning

Austedo contains a boxed warning, the FDA’s most serious type of warning, regarding the risk of depression and suicidality in patients with Huntington’s disease. Clinical trials showed an increased risk of suicidal thoughts and behaviors in patients taking this class of medication for Huntington’s chorea. Healthcare providers are advised to balance the risks of depression and suicide with the clinical need for chorea treatment and to monitor patients closely for new or worsening symptoms.

Regulatory Requirements

Austedo is a prescription-only medication. While it does not require a specific Risk Evaluation and Mitigation Strategy (REMS) program, it must be dispensed with a Medication Guide that explains its risks and proper use. The medication is contraindicated in patients who are actively suicidal or who have untreated or inadequately treated depression. It is also contraindicated in patients with hepatic impairment and those taking certain other medications, such as monoamine oxidase inhibitors (MAOIs) or reserpine.

Question 11

What should I know about Austedo and cost?

Accepted Answer

Insurance and Coverage

The out-of-pocket cost for Austedo is largely determined by an individual's health insurance plan. Most commercial insurance, Medicare, and Medicaid plans cover the medication, though it is often classified as a specialty drug. This classification may require patients to obtain prior authorization from their insurance provider before the prescription is approved for coverage.

Specialty Pharmacy Access

Austedo is typically dispensed through specialty pharmacies rather than standard retail locations. These pharmacies specialize in medications for complex conditions and can often assist with navigating insurance requirements and identifying financial support options.

Financial Assistance

For those who are uninsured or have high copays, several options may help manage expenses:

Copay Savings Cards: Eligible patients with commercial insurance may use manufacturer copay cards to lower their monthly out-of-pocket costs.

Patient Assistance Programs: Programs may be available for individuals who meet specific income and eligibility criteria, providing the medication at a reduced cost or for free.

The total price also depends on the prescribed strength and whether the patient is taking the standard tablets or the extended-release (XR) version of the medication.

Austedo

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