What is Xiapex - Collagenase?
Xiapex is a powder and solvent for solution for injection, containing the active ingredient collagenase of Clostridium histolyticum.
What is Xiapex - Collagenasi used for?
Xiapex is indicated for the treatment of Dupuytren's contracture in adult patients. Dupuytren's contracture is a condition whereby 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, thus forming "cords" responsible for the contraction of the fingers. Xiapex is indicated in patients with sufficiently thick ropes in their palms to be perceived by touch.
The medicine can only be obtained with a prescription.
How is Xiapex - Collagenasi used?
Xiapex must be administered by a doctor who has been adequately trained in the correct administration of the product and is experienced in diagnosing and treating Dupuytren's disease.
The doctor injects the appropriate dose of Xiapex directly into a palpable cord in the patient's palm. About 24 hours after the injection the doctor can extend the finger performing an "extension procedure" for about 10-20 seconds, in order to facilitate the breaking of the rope. One rope can be treated at a time. If a satisfactory response with an injection and extension is not obtained, the procedure can be repeated at monthly intervals up to a maximum of three administrations per cord. For more information on the use of Xiapex, including instructions for performing the finger extension procedure, see the summary of product characteristics (included with the EPAR).
How does Xiapex - Collagenasi work?
In patients with Dupuytren's contracture, the cords in the palm that prevent the extension of the fingers are made of fibers of a protein called collagen. Xiapex contains a mixture of two "collagenases", ie enzymes that cause collagen breakdown. Collagenases destroy collagen fibers when given in a cord. In this way the rope is weakened and degraded, sometimes with the help of the extension of the finger.
The collagenases present in Xiapex are extracted from the bacterium Clostridium histolyticum.
What studies have been carried out on Xiapex - Collagenasi?
The effects of Xiapex were first tested in experimental models before being studied in humans.
Xiapex has been compared to placebo (an ineffective substance on the body) in two major studies involving a total of 374 Dupuytren's adult subjects. The medicine was given to patients three times; three months after the last injection a hand examination was carried out to determine the degree of joint flexibility. 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 subjects treated with Xiapex were able to extend their fingers up to 5 degrees compared to 7% (7 of 103) of patients treated with placebo. In the second study, the percentages recorded were 44% (20 of 45) for the group treated with Xiapex compared to 5% (1 of 21) for the placebo group.
What are the risks associated with Xiapex - Collagenasi?
The most frequent side effects seen with Xiapex were reactions at the injection site such as swelling, bruising, bleeding and tenderness. Injection site reactions have been very frequent and have been reported by the vast majority of patients. These were mostly mild to moderate reactions and generally resolved within a week or two. For the full list of all side effects reported with Xiapex, see the Package Leaflet.
Xiapex should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other substances.
Why has Xiapex - Collagenasi been approved?
The CHMP decided that Xiapex's benefits are greater than its risks and recommended that it be given marketing authorization.
What measures are being taken to ensure the safe use of Xiapex - Collagenasi?
The company that makes Xiapex must ensure that all doctors who could use the medicine are properly 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 doctors on the correct use and potential side effects associated with the medicine.
More information on Xiapex - Collagenasi
On 28 February 2011, the European Commission granted a marketing authorization valid for the Xiapex, valid throughout the European Union, to Pfizer Limited. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 01-2011.
