Xiapex is shown to be well-tolerated with a manageable safety profile<sup>1</sup>

Most of the side effects that occured in the clinical studies were mild or moderate in severity and were localised to the hand treated. They generally subsided within 1-2 weeks post-injection.1,2,3

Clinical trials
Serious adverse reactions were uncommon (>1/100 to <1/100).1 Three cases of tendon rupture and one case of other ligament injury were reported in Xiapex clinical studies. No permanent nerve injury was reported with Xiapex.1

The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in Study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren’s contracture (CORD I and CORD II, n=249) (skin laceration 8.8%). There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (ie, most adverse events were local to the treated extremity and of mild or moderate intensity).1

Cases of skin laceration requiring skin graft after finger extension procedures have been reported post-marketing. Signs or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be promptly evaluated because surgical intervention may be required.1


IMPORTANT

Xiapex must be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and management of Dupuytren’s disease.1


Patients with treatment-related adverse events from the clinical development programme <sup>10</sup>
Adverse reaction Xiapex (n=1082)
Odema peripheral 76.7%
Cortusion 54.2%
Injection-site pain 40.6%
Pain in extremity 35.8%
Injection-site haemorrhage 34.0%
Tenderness 28.5%
Injection-site swelling 24.5%
Ecchymosis 17.9%
Pruritus 12.5%
Skin laceration 10.9%
Lymphadenopathy 10.9%
Blood blister 9.0%
Axillary pain 6.7%
Injection-site pruritus 5.3%
Haematoma 5.2%

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Dupuytren’s disease

Peyronie’s disease