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GALZIN™
(zinc acetate), an effective new weapon in the treatment of Wilson's
Disease, has been approved by the FDA. Used as a maintenance
treatment for Wilson's Disease, this drug is a vital alternative to
chelating agents (penicillamine and trientine)--until now the only
form of therapy for this disease.
Patients with symptomatic Wilson's Disease must, initially, undergo a treatment
with a chelating agent. Used as an initial therapy, chelating agents
work by bonding with
copper (and other heavy metals) to form stable complexes that are
excreted in the urine. In some patients, these medications can cause serious, even life-threatening, adverse reactions and may be associated
with a greater incidence of fetal abnormalities. Patients with Wilson's Disease who
develop adverse reactions to chelating agents can be treated with
GALZIN.
Following the initial treatment
with a chelating agent, patients are "maintained" on lower
dosages of these medications or they can be treated with zinc. Some
patients who are diagnosed before they develop symptoms can be
treated with zinc or maintenance dosages of chelating agents from
the outset.
GALZIN is a
particularly effective alternative for maintenance treatment because
it has shown no long-term or major side effects in patients. GALZIN appears to
induce the intestinal production of metallothionein, a protein with
a high affinity for copper. This action blocks copper absorption by
binding copper to this protein in the intestinal cells or
enterocytes. This means that any newly ingested
copper does not reach the circulation system and is excreted mainly
in the stool.
GALZIN can be taken by pregnant women and even young
children, though there is little data on its use in children under 5
years of age. For pregnant women, this means GALZIN can be taken without
dosage reduction in all trimesters of pregnancy. In studies of
patients using GALZIN during pregnancy, there has been no evidence
of increases in the risk of fetal abnormalities with its use. GALZIN
can be used, long-term, in place of non-tolerable chelating agents
and can, therefore, be a major weapon to fight this rare, otherwise
progressive, illness.
GALZIN is a breakthrough in the treatment of Wilson's Disease. For
more information about GALZIN (zinc acetate):
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Basic Treatment for Wilson's Disease
- Dose: 50 mg tid.
- Separate from food and beverages (other than water) by one
hour.
- Food: Avoid liver, limit
shellfish.
- Check drinking water. Restrict intake if copper is more
than 0.1 ppm (0.1 µg/L).
- Monitor:
Urine Cu and Zn every 6 months.
Urine Cu: reflects body Cu loading
(good control, less than 125 µg/24hour.)
Urine Zn: reflects compliance
(good compliance, more than 2 mg/24hour.)
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How to Obtain Galzin
Here is a list of various
sources for GALZIN™. When you call one of the telephone numbers
listed here, if the person who answers the phone is not familiar
with GALZIN™, ask to speak to the Medical Director. If you
still have problems obtaining GALZIN™ after contacting the
organizations listed below, please contact:
GATE Pharmaceuticals
1090 Horsham Road
P.O. Box 1090
North Wales, PA 19454
USA
Phone: (800) 292-4283
Fax: (215) 591-8801
E-mail: infoGATE@tevausa.com
Contact Name: Galzin Product Manager
Baltic
States
Swedish Orphan AB
Drottninggatan 98
SE-111 60 STOCKHOLM
Sweden
Phone: 46 8 402 83 30
Fax: 46 8 411 12 54
Canada
Your physician must contact:
The Emergency Drug Release Program
Finance Building
Tunney's Pasture
Postal Locator 0202C1
Ottawa, Ont.
K1A 1B6
Phone: (613)-941-2108
Fax: (613)-941-3194
Denmark and
Finland
Swedish Orphan AB
Drottninggatan 98
SE-111 60 STOCKHOLM
Sweden
Phone: 46 8 402 83 30
Fax: 46 8 411 12 54
France
Orphan Europe SARL
Immeuble "Le Guillaumet"
60, avenue du President Wilson
92046 PARIS LA DEFENSE
France
Phone: 33 1 47 73 64 58
Fax: 33 1 49 06 00 04
E-mail: fra@orphan-europe.com
Contact Names: Dr. Bielski; Dr. Kibleur or Mr. Mambrimi
Germany
Orphan Europe (Germany) GmbH
Max-Planck-Strabe 6
63128 Dietzenbach
Germany
Phone: 49 60 74 81 21 60
Fax 49 60 74 81 21 66
E-mail: info.d@orphan-europe.com
Iceland
Swedish Orphan AB
Drottninggatan 98
SE-111 60 STOCKHOLM
Sweden
Phone: 46 8 402 83 30
Fax: 46 8 411 12 54
Italy
Orphan Europe Italy
Via Cellini, 11
20090 Segrate (Milano)
Italy
Phone: 39 2 26 95 00 27
Fax: 39 2 26 95 36 74
E-mail: cdutch@orphan-europe.com
Middle Eastern
countries
Orphan Europe SARL
Immeuble "Le Guillaumet"
60, avenue du President Wilson
92046 PARIS LA DEFENSE
France
Phone: 33 1 47 73 64 58
Fax: 33 1 49 06 00 04
E-mail: fra@orphan-europe.com
Contact Names: Dr. Bielski; Dr. Kibleur or Mr. Mambrimi
Norway
Swedish Orphan AB
Drottninggatan 98
SE-111 60 STOCKHOLM
Sweden
Phone: 46 8 402 83 30
Fax: 46 8 411 12 54
Spain
Orphan Europe Spain
Gran Via de les Corts Catalanes 774, 50 4a
08013 Barcelona
Spain
Phone: 34 932 440 930
Fax: 34 932 479 028
E-mail: jrius@orphan-europe.es
Sweden
Swedish Orphan AB
Drottninggatan 98
SE-111 60 STOCKHOLM
Sweden
Phone: 46 8 402 83 30
Fax: 46 8 411 12 54
United Kingdom
Orphan Europe (UK) Ltd
32 Bell Street
Henley-on-Thames
OXFORDSHIRE RG9 2BH
United Kingdom
Phone: 44 1491 414 333
Fax: 44 1491 414 443
E-mail: info.uk@orphan-europe.com
United States
Walgreen Specialty Pharmacy
Phone: (866) 493-2550
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OpenGATE MedAssist
Program
GATE Pharmaceuticals offers
the OpenGATE MedAssist prescription assistance program for those
who qualify. Below are the requirements and procedures for a patient to enroll in the OpenGATE MedAssist
Program.
| Pharmaceutical
Company |
GATE
Pharmaceuticals |
| Program
Address |
GATE
Pharmaceuticals
P.O. Box 1090
1090 Horsham Road
North Wales, PA 19454 |
| Toll Free
Telephone Number |
800-292-4283,
ext. 8921 |
| Fax Number |
215-591-8823 |
| Guidelines |
Patients must
be U.S. residents who do not qualify for government or
private prescriptions or programs that do not pay for BRAND
NAME pharmaceuticals. Income requirements: $18,000 or less
annual income for individuals, $24,000 or less for
couples, $35,000 or less for familys of four. Should
special circumstances apply, request for an exception can
be made. |
| Enrollment
Initiation |
Phone request
for enrollment forms must be made by physician. Forms will
be faxed to physician's office. |
| Physician's
Role |
Complete
forms with ORIGINAL signature. A prescription must be
written for up to a 90-day supply with three refills, signed
by a licensed physician, and dated. Original
completed forms must be mailed to GATE Pharmaceuticals.
Changes in dosage, directions, or physician require a new
physician form and a new prescription. Denied requests or
incomplete forms will be returned to physician. |
| Patient's
Role |
Complete form
and supply all necessary documentation. PATIENT ORIGINAL
SIGNATURE or that of legal guardian is required. Completed
form and documentation are returned to physician for
submittal. Incomplete/illegible forms will be returned to
physician. |
| How
Dispensed |
Medication
will be sent to physician in stock bottles of 100 tablets
(ORAP®) or 250 tablets (Galzin™). Patient's
name will be on mailing label, not on bottle. Physician
will be responsible for patient dosing directions. Fifteen
business days must be allowed for processing. |
| Refills |
Up to three
refills are allowed on one prescription. Prescription may
be written for one calendar year. Refill requests must be
phoned by physician to GATE Pharmaceuticals. Fifteen
business days must be allowed for processing. |
| Liability |
GATE
Pharmaceuticals is not responsible for dosing errors,
labeled adverse reactions, concomitant medication
interactions, use in disease states that are
contraindicated for the product, or use of product for
indication other than that approved by the FDA. |
| Limits |
GATE
Pharmaceuticals will make every effort to grant aid to a
patient in need. However, this program is limited by
available resources and may be discontinued at any time. |
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