Tetrabenazine

Compiled by Kevin J. Black, M.D.  (last update September, 2000)


Comes in 25mg scored tablets. Usual final dose in retrospective study cited below was 25-75mg/day, maximum dose during treatment was (average) 106mg/day.

Can be obtained in U.S. with a physician's prescription using the directions below.
 
September, 2000, letter from Cambridge Laboratories to patients:
Dear Sir

Re: Tetrabenazine tablets 25mg, 112 tablets per pack

Thank you for your recent enquiry regarding the supply of tetrabenazine tablets for medicinal use.  We are pleased to inform you that Cambridge Laboratories is able to supply tetrabenazine directly to you in the USA on a named patient basis. We are able to do this under section 9-71-30C of the FDA regulations for pharmaceuticals imported for personal use.

Please forward you fax number and upon receipt we will be able to fax the appropriate product information. 

Tetrabenazine is currently in stock and is therefore available for immediate despatch to you.  The cost of an individual pack of 112 tablets of tetrabenazine is £100.00 (approx. $150 at current exchange rates). In addition there would be a handling charge of £10 and courier costs of approximately £50.  It is possible however to order larger quantities from us.  This will mean that you will not need to worry about remembering to place an order with us on a monthly basis, and in addition on orders of 10 packs or more we will pay both the handling and courier charges for you.  We will of course ensure that all medicines supplied will have more than sufficient shelf life to cover the likely treatment period.

Either the prescribing physician or the patient can obtain tetrabenazine from us. The FDA requires that certain regulations are complied with when importing medicines for personal use.  To ensure that these regulations are complied with and you therefore receive your medicine without any undue delay please use the attached letter for your order.

Unfortunately, we will require full payment prior to the despatch of the medicines but payment can easily be made in any of the following ways

-Mastercard
-Visa
-Directly to our bank

Our bank details are:   National Westminster
                        Bishopsgate Corporate Business Centre
                        PO Box No 34
                        15 Bishopsgate
                        London
                        EC2P 2AT

Sort Code       :       50-00-00

Account name    :       Cambridge Laboratories Limited

Account number  :       95 48 42 13
 

If paying by Mastercard or Visa could you please provide the following details:

-card number
-date of expiry
-name and address of cardholder as registered with the credit card company
 

Thank you for your interest in our product, we will do all we can to make the supply of tetrabenazine to you as smooth as possible.  If you require any further help or assistance please do not hesitate to contact any member of our customer services department.  Their names are Alyson, Angela, Liz, Felicity and Caroline.

Kind regards
 

Alyson Nearn 
Customer Services 

Physician and patient complete the following form, then mail it with a prescription to Cambridge Laboratories:
Order form (Microsoft Word format)             KJB patients only
Contact info for further questions:
Diana Boyd, Operations Manager and Company Secretary
phone: 011-44-191-296-9311
email: diana.boyd@camb-labs.com
fax: 011-44-191-296-9368


excerpt from an email from Dr. Jankovic dated 5/13/99:

TETRABENAZINE

Joseph Jankovic, M.D.
Director, Parkinson's Disease Center and Movement Disorders Clinic
Department of Neurology, Baylor College of Medicine
6550 Fannin #1801, Houston, Texas 77030

        The observation that antidopaminergic drugs ameliorate hyperkinetic movement disorders has been well accepted although a clear pharmacologic rationale is still lacking. Dopamine receptor blocking drugs (DRBD) have been used in the treatment of chorea, dystonia, tics, tardive dyskinesia, and other hyperkinesia, but these drugs can be associated with potentially serious complications, including tardive syndromes. Tetrabenazine (TBZ), a synthetic benzoquinolizine that depletes presynaptic storage of monoamines and blocks postsynaptic dopamine receptors has the advantage over the conventional neuroleptics (DRBD) in that it rarely causes a dystonic reaction and there has been no documented case of tardive dyskinesia reported secondary to TBZ.  The primary pharmacologic action of TBZ is depletion of dopamine and other monoamines in the central nervous system. The drug also blocks dopamine receptors.

        TBZ was first introduced as an antipsychotic drug in 1960, but it is currently used most frequently outside the United States in the treatment of hyperkinetic movement disorders. In 1982, we first documented the beneficial effects of TBZ in a placebo-controlled, double-blind trial.  Since that time we have treated hundreds of patients. After about 2-year course of TBZ, the clinical improvement was rated as marked in 89.2% of 93 patients with tardive stereotypy, 83.3% of 12 with myoclonus, 82.8% of 29 with Huntington's disease, 80.5% of 82 with tardive dystonia, 79.3% of 29 with other movement disorders, 62.9% of 108 with idiopathic dystonia, and in 57.4% of 47 with Tourette's syndrome.  The most common side effects included drowsiness (44.6%), parkinsonism (34.9%), depression  (18.3%), insomnia (13.5%), nervousness/anxiety (12.5%), and akathisia (11.6%). The side effects were controlled with reduction in the dosage.

        Although it is possible that TBZ will be eventually available for clinical use in the U.S.A. (a multicenter trial is being planned), the drug is currently considered investigational in this country. ...

References:

Jankovic J. Tardive syndromes and other drug-induced movement disorders. Clin Neuropharmacol 1995;18:197-214.

Jankovic J, Beach J. Long-term effects of tetrabenazine in hyperkinetic movement disorders. Neurology 1997;48:358-362.


Other info
FDA Orphan Drugs 1-800-300-7469
The company listed below should be the one to contact to try to move its approval along. However, when I wrote to this company in 1999 the info was wrong (see link below). /kjb


Subject:        RE: [Fwd: fw: tetrabenazine reply from fda Fw: FDA question]
   Date:        Thu, 2 May 2002 15:18:23 -0400
   From:        "CDER DRUGINFO" <DRUGINFO@cder.fda.gov>
    To:        "'kevin@npg.wustl.edu'" <kevin@npg.wustl.edu>

... on the orphan drug page i found the following on tetrabenazine. You can make contact this way:

Generic Name: Tetrabenazine
Trade Name:
Orphan Indication: Treatment of moderate/severe tardive dyskinesia.
Sponsor Lifehealth Limited Contact Mr. Robert Rosen
Address SL4 4BA, UK Phone: (415) 332-6753 Fax: (415) 332-6751
Status: Designated Designation 12-May-9 Marketing Approval

---------------------------------------------------------------------

Generic Name: Tetrabenazine
Trade Name:
Orphan Indication: Treatment of Huntington's disease.
Sponsor Lifehealth Limited Contact Mr. Robert Rosen
Address SL4 4BA, UK Phone: (415) 332-6753 Fax: (415) 332-6751
Status: Designated Designation 11-Dec-9 Marketing Approval

mk11


my 1999 info on tetrabenazine, now outdated


Kevin J. Black, M.D.  (initially posted May, 1999)