What is Wilzin?
Wilzin is supplied as blue (25 mg) or orange (50 mg) capsules containing the active ingredient zinc acetate dihydrate.
What is Wilzin used for?
Wilzin is used for the treatment of Wilson's disease, a rare inherited disorder. Patients suffering from Wilson's disease lack an enzyme necessary to eliminate the copper in food, thus accumulating an excessive amount of this substance in the body. Copper first accumulates in the liver and subsequently in other organs such as the eye and the brain. This produces a number of effects, including liver disease and damage to the nervous system.
On 31 July 2001 Wilzin was designated an orphan medicinal product for the treatment of Wilson's disease.
The medicine can only be obtained with a prescription.
How is Wilzin used?
Wilzin therapy should be instituted by a physician experienced in the treatment of Wilson's disease. The usual dose for adults is 50 mg three times a day with a maximum dose of 50 mg five times a day. In children the dose is reduced - please refer to the package insert. Wilzin should be taken on an empty stomach, at least an hour before or 2-3 hours after meals. Witzin is a long-term therapy. Initially it is important that patients who already have the symptoms of the disease also undergo another therapy (with a chelating agent), because Wilzin begins to benefit only after some time.
How does Wilzin work?
The active ingredient of Wilzin is the zinc cation (positively charged zinc), which blocks the absorption of the copper contained in the food. Wilzin induces the production of metallothionein, a protein that binds copper by preventing its transfer into the blood. The bound copper is then eliminated in the faeces. Reducing the amount of copper in the body improves the symptoms of the disease.
What studies have been carried out on Wilzin?
The data confirming the efficacy of Wilzin come from 255 patients. Most of these patients took the medicine as part of an "uncontrolled" study, in which Wilzin was not compared to any placebo (a dummy treatment) or to medicines already used for the treatment of
this disease. The main efficacy index of the medicine was adequate control of copper levels in patients.
What benefit has Wilzin shown during the studies?
Wilzin was effective in significantly reducing copper absorption and the amount of copper in the body. In the main study conducted, 91% of patients achieved adequate control of copper levels in the body within the first year of treatment.
What are the risks associated with Wilzin?
The most common side effect is gastric irritation. This is generally worse after the first morning dose and disappears after the first few days of therapy. This effect can be alleviated by delaying the first dose in mid-morning or taking the dose with a small amount of protein-containing foods (for example, meat). Among other side effects an increase in certain blood enzymes has been reported.
For the full list of all side effects reported with Wilzin, see the Package Leaflet.
Wilzin should not be given to patients allergic to zinc.
Why was Wilzin approved?
Because Wilson's disease is a life-threatening disease and medicines already used for treatment have side effects, the Committee for Medicinal Products for Human Use (CHMP) has decided that Wilzin's benefits are greater than its risks and has therefore recommended the release of marketing authorization for this medicinal product.
Other information:
On October 13, 2004, the European Commission issued a marketing authorization for Wilzin, valid throughout the European Union, to Orphan Europe SARL.
For the assignment of the status of an orphan medicine to Wilzin, see: //pharmacos.eudra.org/F2/register/o050.htm.
For the full version of the evaluation (EPAR) of Wilzin, click here.
Last update of this summary: 12-2005
