Xiapex - Collagenase
What is Xiapex - Collagenase?
Xiapex is a powder and solvent for solution for injection, containing the active substance Clostridium histolyticum collagenase.
What is Xiapex - Collagenase used for?
Xiapex is indicated for the treatment of Dupuytren's contracture in adult patients. Dupuytren's contracture is a condition in which one or more fingers of the hand flex towards the palm without being able to fully extend. It is caused by a thickening of the subcutaneous tissues of the palm, which thus form "cords" responsible for the contracture of the fingers. Xiapex is indicated in patients who have chords in the palms that are thick enough to be felt to the touch.
The medicine can only be obtained with a prescription.
How is Xiapex - Collagenase used?
Xiapex should be administered by a physician adequately trained in the correct administration of the product and experienced in the diagnosis and treatment of Dupuytren's disease.
The doctor injects the appropriate dose of Xiapex directly into a palpable string in the patient's palm. Approximately 24 hours after the injection, the doctor may extend the finger by performing an "extension procedure" for approximately 10-20 seconds to facilitate the breaking of the string. You can treat one string at a time. satisfactory response with one "injection and one" extension, the procedure can be repeated at monthly intervals up to a maximum of three administrations per string. For more information on using Xiapex, including instructions for performing the extension procedure finger, please refer to the summary of product characteristics (enclosed in the EPAR).
How does Xiapex - Collagenase work?
In patients with Dupuytren's contracture, the cords in the palm that prevent finger extension are made up of fibers of a protein called collagen. Xiapex contains a mixture of two "collagenases," which are enzymes that break down collagen. When given. in a string, collagenases destroy collagen fibers, thereby weakening and degrading the string, sometimes with the help of finger extension.
The collagenases present in Xiapex are extracted from the bacterium Clostridium histolyticum.
How has Xiapex - Collagenase been studied?
The effects of Xiapex were first tested in experimental models before being studied in humans.
Xiapex was compared to placebo (a substance with no effect on the body) in two major studies involving a total of 374 adults with Dupuytren's contracture. The medicine was given to patients three times; three months after the last. an examination of the hand was performed to establish the degree of flexibility of the joints. The main measure of effectiveness was the percentage of patients in whom the most affected joint could be flexed forward by no more than 5 degrees.
What benefit has Xiapex - Collagenase shown during the studies?
Xiapex was more effective than placebo in treating Dupuytren's contracture. Among the patients who completed the first study, 64% (130 out of 203) of the subjects treated with Xiapex were able to extend their fingers by up to 5 degrees compared with 7% (7 out of 103) of the patients treated with placebo. In the second study, the percentages recorded were 44% (20 out of 45) for the Xiapex group compared to 5% (1 out of 21) for the placebo group.
What are the risks associated with Xiapex - Collagenase?
The most frequent side effects seen with Xiapex were injection site reactions such as swelling, bruising, bleeding and tenderness. Injection site reactions were very frequent and were reported by the vast majority of patients. These were mostly mild to moderate reactions and usually resolved within a week or two. For the full list of side effects reported with Xiapex, see the package leaflet.
Xiapex must not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other substances.
Why has Xiapex - Collagenase been approved?
The CHMP decided that Xiapex's benefits are greater than its risks and recommended that it be given a Marketing Authorization for this medicine.
What measures are being taken to ensure the safe use of Xiapex - Collagenase?
The company that makes Xiapex must ensure that all doctors who may use the medicine are adequately trained in the correct administration of the product and have experience in the diagnosis and treatment of Dupuytren's disease. The company must also organize a training program for physicians on the correct use and potential side effects associated with the medicine.
More information about Xiapex - Collagenase
On February 28, 2011, the European Commission granted Pfizer Limited a "Marketing Authorization" for Xiapex, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
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