Xenazine (tetrabenazine)
An approved treatment for Huntington Disease.
The same compound appears under different names depending on the context. Here is how to identify Tetrabenazine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Tetrabenazine
- Brand name
- Xenazine
- International name
- Nitoman (Canada, Germany, UK)
- Drug class
- VMAT2 inhibitor
- Manufacturer
- Lundbeck
- How it's taken
- Taken orally, typically 3 times daily.
The first FDA-approved treatment specifically for Huntington disease chorea. Reduces involuntary movements by decreasing dopamine signaling in the brain.
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Where Tetrabenazine fits
First FDA-approved treatment specifically for Huntington's chorea. Now available as a cost-effective generic, though deutetrabenazine and valbenazine offer improved dosing profiles.
How Tetrabenazine works
Tetrabenazine blocks VMAT2, a transporter that loads dopamine into vesicles for release at nerve terminals. By reducing the amount of dopamine released, it decreases the excessive signaling that drives the involuntary choreiform movements characteristic of Huntington disease.
Mechanism: VMAT2 inhibitor that reduces dopamine release to control involuntary movements
Side effects and safety
Carries a black box warning for depression and suicidality. Patients must be screened for depression before starting treatment. It must not be used by people who are actively suicidal or have untreated or undertreated depression, people with liver impairment, or people taking an MAO inhibitor, reserpine, deutetrabenazine or valbenazine. It can cause neuroleptic malignant syndrome, a potentially fatal reaction with high fever, stiff muscles and confusion that needs emergency care. It can also prolong the QT interval (a change in heart rhythm), so it should be avoided with other drugs that do this and in people with congenital long QT syndrome or a history of irregular heartbeat. The label also warns about parkinsonism (stiffness and slowed movement), drowsiness that can affect driving, dizziness or low blood pressure on standing, higher prolactin levels, and possible buildup in pigmented tissues such as the eye. Common side effects include sedation, fatigue, insomnia, depression, akathisia, nausea, and anxiety. CYP2D6 genotyping required for doses above 50 mg/day.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Tetrabenazine
Taken orally, typically 3 times daily. Requires slow dose titration over several weeks. Maximum dose depends on CYP2D6 metabolizer status.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
VMAT2 inhibitor available in generic form. First drug specifically approved for Huntington's chorea, with straightforward small molecule manufacturing.
Help paying for Xenazine
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients age 17+ pay at least $10 per 30-day prescription; a maximum benefit limit may apply. Not for Medicare, Medicaid, VA, DoD, TRICARE or self-pay.
For: private insurance · source - Insurance and case manager help
Xenazine Information Center gives insurance coverage information and information on other Lundbeck support programs after a Xenazine Treatment Form is submitted.
The official page does not say who qualifies. Ask the program. · source
Good to know: Applies to brand Xenazine (Lundbeck) only. Generic tetrabenazine is widely available from other makers and is not covered by this program.
No charity fund for this condition is open right now. Funds reopen when they receive new donations; the foundations let you sign up to be told when one opens.
Clinical trial results
Phase 3 TETRA-HD trial demonstrated significant reduction in chorea severity versus placebo over 12 weeks. First drug proven effective for Huntington chorea in a randomized controlled trial.
Development history
Approved by FDA in August 2008 as the first treatment specifically for Huntington disease. Used in other countries for decades before US approval. Largely superseded by deutetrabenazine (Austedo) which offers better tolerability and dosing convenience.
Explore Huntington Disease trials
Other Huntington Disease treatments
Common questions about Tetrabenazine
▸What is Tetrabenazine (Xenazine)?
The first FDA-approved treatment specifically for Huntington disease chorea. Reduces involuntary movements by decreasing dopamine signaling in the brain.
▸How does Tetrabenazine work?
Tetrabenazine blocks VMAT2, a transporter that loads dopamine into vesicles for release at nerve terminals. By reducing the amount of dopamine released, it decreases the excessive signaling that drives the involuntary choreiform movements characteristic of Huntington disease.
▸What are the side effects of Tetrabenazine?
Carries a black box warning for depression and suicidality. Patients must be screened for depression before starting treatment. It must not be used by people who are actively suicidal or have untreated or undertreated depression, people with liver impairment, or people taking an MAO inhibitor, reserpine, deutetrabenazine or valbenazine. It can cause neuroleptic malignant syndrome, a potentially fatal reaction with high fever, stiff muscles and confusion that needs emergency care. It can also prolong the QT interval (a change in heart rhythm), so it should be avoided with other drugs that do this and in people with congenital long QT syndrome or a history of irregular heartbeat. The label also warns about parkinsonism (stiffness and slowed movement), drowsiness that can affect driving, dizziness or low blood pressure on standing, higher prolactin levels, and possible buildup in pigmented tissues such as the eye. Common side effects include sedation, fatigue, insomnia, depression, akathisia, nausea, and anxiety. CYP2D6 genotyping required for doses above 50 mg/day.
▸How is Tetrabenazine taken?
Taken orally, typically 3 times daily. Requires slow dose titration over several weeks. Maximum dose depends on CYP2D6 metabolizer status.
▸Is Tetrabenazine FDA approved?
Yes, Tetrabenazine (Xenazine) is FDA approved (2008) for the treatment of Huntington Disease.
▸Why was tetrabenazine historically important for Huntington disease?
Approved in August 2008, tetrabenazine was the first FDA-approved treatment specifically for Huntington disease chorea. It had been used in other countries for decades before gaining US approval and established VMAT2 inhibition as a treatment approach.
▸Why has tetrabenazine been largely replaced by newer options?
Tetrabenazine requires three-times-daily dosing with a complex titration schedule, while deutetrabenazine and valbenazine offer once-daily options with potentially fewer side effects. However, tetrabenazine is now available as a cost-effective generic.
▸What is the depression risk with tetrabenazine?
Tetrabenazine carries a black box warning for depression and suicidality. All patients must be screened for depression before starting treatment, and ongoing monitoring is required. The drug should be discontinued if significant depression develops.
▸Is CYP2D6 genetic testing required?
CYP2D6 genotyping is required for doses above 50 mg per day. The maximum dose depends on whether the patient is an extensive, intermediate, or poor CYP2D6 metabolizer.
▸Is generic tetrabenazine available?
Yes. Tetrabenazine is available as a generic medication, making it a cost-effective option for patients and health systems, though the three-times-daily dosing schedule is less convenient than newer alternatives.
▸What is tetrabenazine known as outside the US?
Tetrabenazine is marketed as Nitoman in Canada, Germany, and the UK. It was used internationally for movement disorders long before receiving FDA approval in 2008.