Xiapex

collagenase Clostridium histolyticum

This is a summary of the European public assessment report (EPAR) for Xiapex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiapex.

What is Xiapex?

Xiapex is a powder and solvent that are made up into a solution for injection. It contains the active substance collagenase Clostridium histolyticum.

What is Xiapex used for?

Xiapex is used to treat Dupuytren’s contracture in adults. Dupuytren’s contracture is a condition where one or more fingers are bent forwards toward the palm and cannot be fully straightened. It is caused by a thickening of the tissues under the skin of the palm that form ‘cords’ pulling down on the fingers. Xiapex is to be used in patients with cords in their palms that are thick enough to be felt through the skin.

The medicine can only be obtained with a prescription.

How is Xiapex used?

Xiapex must be given by a doctor trained in the use of the medicine and experienced in diagnosing and managing Dupuytren’s contracture.

The doctor injects the appropriate dose of Xiapex directly into a cord in the patient’s palm. Around 24 hours after the injection, the finger can then be straightened by the doctor, by performing a ‘finger extension procedure’ whereby it is stretched out for around 10 to 20 seconds to help disrupt the cord. Only one cord should be treated at a time. If one injection and finger extension has not brought about a satisfactory response, the procedure may be repeated at monthly intervals up to a maximum of three injections per cord. For more information on the use of Xiapex, including instructions on finger extension procedures, see the summary of product characteristics (also part of the EPAR).

How does Xiapex work?

In patients with Dupuytren’s contracture, the cords in the palm that prevent finger from straightening are made of fibres of a protein called collagen. Xiapex contains a mixture of two ‘collagenases’, enzymes that break up collagen. When injected into a cord, the collagenases break up the collagen fibres. This weakens and disrupts the cord, sometimes with the help of finger extension.

The collagenases in Xiapex are extracted from the bacterium Clostridium histolyticum.

How has Xiapex been studied?

The effects of Xiapex were first tested in experimental models before being studied in humans.

Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren’s contracture. The patients were treated with three injections and their hands were examined three months after the last injection to see how much the finger joints could be straightened out. The main measure of effectiveness was the proportion of patients whose main affected joint could be straightened so that it was bent forwards by no more than 5 degrees.

What benefit has Xiapex shown during the studies?

Xiapex was shown to be more effective at treating Dupuytren’s contracture than placebo. Among patients who completed the first study, 64% (130 out of 203) of those receiving Xiapex could straighten their fingers to an angle of 5 degrees or less compared with 7% (7 out of 103) of patients receiving placebo. In the second study the figures were 44% (20 out of 45) for the Xiapex group and 5% (1 out of 21) for the placebo group.

What is the risk associated with Xiapex?

The most common side effects seen with Xiapex were local injection-site reactions such as swelling, bruising, bleeding and pain. Injection-site reactions were very common, occurring in the vast majority of patients. These reactions were mostly mild to moderate in severity and generally subsided within one to two weeks. 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 ingredients.

Why has Xiapex been approved?

The CHMP decided that Xiapex’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Xiapex?

The company that makes Xiapex must ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren’s contracture. The company must also carry out an educational programme for doctors on the correct use and the potential side effects associated with the medicine.

Other information about Xiapex

The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex on 28 February 2011.

For more information about treatment with Xiapex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 03/05/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

09/04/2013  Xiapex -EMEA/H/C/002048 -T/0021

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other drugs for disorders of the musculoskeletal system

Therapeutic indication

Xiapex is indicated for the treatment of Dupuytren’s contracture in adult patients with a palpable cord.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents