LaVonne Goodman wrote the below article that explains what HD families must do
in order to get a prescription for Xenazine filled. It's an excellent article,
which also includes the history of getting this medication approved by HDSA so
please go to the link to read it all! Plus there are links to the Ovation
Patient Assistance Program and the Ovation Ovation U.S. Marketed Products -
Physician Information.

"Tetrabenazine [Xenazine] is Finally Here: Use if Carefully"
Dr. LaVonne Goodman HDDW November 19, 2008
http://hddrugworks.org/index.php?option=3Dcom_content&task=3Dview&id=3D241&Itemi\
d=3D30


The Program:

The process for getting this drug is harder than most, but for many who suffer
from chorea, it will be worth the effort.

a.. Xenazine will be available only through specialty pharmacies designated by
Ovation, not local pharmacies beginning the week of November 24, 2008.
a.. Your doctor must first obtain specific prescribing forms and information
pamphlets from an Ovation source. Ovation representatives will be dispatched to
neurology groups and will provide these forms. If your local general doctor
provides your Huntington's care, information and forms must be obtained from
Ovation before you can obtain the drug.
a.. After the doctor faxes the prescription, Ovation will determine whether or
how much your insurance will cover the cost. On average, it will take about 3
weeks to receive the drug by mail. Subsequent refills will be more prompt. If
financial assistance is requested, the initial process will take longer, but
Ovation is willing to supply up to two months of free drug during this process.
You will be asked (but not required) to sign a consent form that will enable the
company to do follow-up assessments (about your response to the medication and
education by your doctor) by phone. This was a requirement for FDA approval.
a.. Xenazine, like any new drug for an orphan disease is very expensive.
However, Ovation is taking exhaustive steps to provide a financial program to
ease the out-of-pocket financial burdens to patients. With appropriate income
documentation, Ovation will provide drug -- free of charge -- for those without
insurance, and when legal will provide at least partial payment of high co-pays.
a.. Those requiring doses larger than 50 mg per day will require specialized
blood testing. Though this drug comes with a very high price tag, this is
customary for new drugs for orphan diseases. In addition the mandated
prescribing process and follow-up procedures are labor intensive and expensive
to administer. The Huntington's community owes Ovation a debt of gratitude for
serving our orphan disease.
Don't Leave it only to the Doctor: Educate Yourself!

Proper dosage of this drug is very important, and remember to report any side
effects to your doctor. The pills come in 12.5 and 25 mg sizes.

a.. It is advised to start low (12.5 mg/day) and go slow, increasing dosage in
one or two week intervals. It is important to see your doctor frequently to
establish best dosing -- one that controls some of the chorea -- without causing
side effects.
a.. The goal is to decrease the severity, and not to stop the chorea because
the dosages required could lead to serious side effects. Common side effects are
fatigue and sleepiness, restlessness, slowness of movement. Depression if not
treated is the most serious side effect and has been associated with suicide.
Often decreasing the dosage of Xenazine will control side effects.
a.. It may be best to use antidepressants other than Prozac (fluoxetine) and
Paxil (paroxetine), amytriptyline (Elavil) and nortriptyline (Pamalor) because
of potential drug interference with Xenazine. If you are already on these
medications, smaller dosages should be used, at least initially. Remember too
that side effects of other medications (antidepressants, antipsychotics) may be
increased by use of Xenazine.
a.. In some cases, dosage can be decreased over time while maintaining effect.
Though Ovation states the drug may be stopped abruptly for a medical indication,
tapering the dose may be more comfortable allowing a more gradual return of
chorea.
a.. Most importantly: Don't forget to see your doctor regularly.


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