Use your expertise to release the hold of Dupuytren’s contracture with XIAPEX1


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Proven efficacy: 85% of all joints injected (172/203) showed clinical improvement*2 Sustained efficacy: 16% of successfully treated joints received further medical/ surgical treatment over the 5-year course of follow-up.3 Resumption of normal activities: The median time to recovery was 4 days4 Cost comparison: Cost of treatment compares favourably to fasciectomy5


Choose Xiapex – proven to be an effective and well-tolerated non-surgical treatment for your patients with Dupuytren’s contracture1


XIAPEX® Abbreviated Prescribing Information (Dupuytren’s contracture) (See XIAPEX Summary of Product characteristics for full Prescribing Information)


Presentation: Powder and solvent for solution for injection for intralesional use. The vial of powder contains 0.9 mg collagenase clostridium histolyticum. Indications: Treatment of Dupuytren’s contracture in adult patients with a palpable cord. Dosage: 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. The recommended dose of Xiapex is 0.58mg per injection into a palpable Dupuytren’s cord. Approximately 24-72 hours after injection, a finger extension procedure may be performed to facilitate cord disruption. Injections and finger extension procedures may be repeated up to 3 times per cord at approximately 4-week intervals. Injections in up to two cords or two affected joints in same hand can be administered. No more than 3 attempts per affected joint and up to 8 injections in total are recommended. For specific details see SmPC. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Allergic reactions - 17% of Xiapex-treated patients in phase 3 placebo-controlled clinical studies had mild allergic reactions (i.e. pruritus). Physicians must be prepared to address any severe local or systemic allergic reactions including the potential for anaphylaxis following injection, and possibly following repeated use. Tendon rupture or other serious injury to the injected extremity – Injection of Xiapex into collagen containing structures of the hand other than the Dupuytren’s cord may result in damage to those structures including possible tendon rupture or ligament damage.


Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex. 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. Use in patients with coagulation disorders – Xiapex must be used in caution in patients with coagulation disorders or those taking anticoagulants. See SmPC for details. Immunogenicity - As with any non-human protein medicinal product, patients may develop antibodies to the therapeutic protein. Long-term safety - Long-term safety of Xiapex is not fully characterised. The impact of treatment with Xiapex on subsequent surgery, if needed, is not known. Drug Interactions: Use of Xiapex in patients who have received tetracycline antibiotics e.g. doxycycline, within 14 days prior to receiving an injection of Xiapex is not recommended. Pregnancy & Lactation: Not recommended in pregnancy. Xiapex can be used during breast feeding. Driving and operating machinery: Xiapex may have a major influence on the ability to drive and use machines due to swelling and pain in the treated hand. Other minor influences include dizziness, paraesthesia, hypoesthesia, and headache. Patients must be instructed to avoid potentially hazardous tasks. Side Effects: In clinical trials, the most frequently reported adverse reactions during Xiapex therapy were local injection site reactions. Injection site reactions were very common, occurring in the vast majority of patients, were mostly mild to moderate in severity and generally subsided within 1-2 weeks post injection. Serious adverse reactions of tendon rupture, tendonitis, other ligament injury and complex regional pain syndrome related to the medicinal product were reported. Very commonly reported adverse reactions include lymphadenopathy, pruritus, ecchymosis, pain in extremity, oedema


peripheral (including injection site oedema and oedema), injection site haemorrhage, injection site pain, injection site swelling, tenderness, contusion. Commonly reported adverse reactions include lymph node pain, paresthesia, hypoesthesia, burning sensation, dizziness, headache, nausea, blood blister, blister, rash, erythema, hyperhidrosis, arthralgia, joint swelling, myalgia, axillary pain, inflammation, injection site inflammation, swelling, injection site erythema, injection site pruritus, injection site warmth, injection site vesicles. For further information refer to summary of product characteristics.


Legal Category: POM. Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden Package Quantities, Marketing Authorisation Numbers and Basic NHS Price: XIAPEX 0.9mg powder and solvent for solution for injection, EU/1/11/671/001, £572.00. Eire List Price: Available on request. Further information is available on request from: Swedish Orphan Biovitrum Ltd. Suite 2, Riverside 3, Granta Park, Great Abington, Cambridgeshire, CB21 6AD Tel: +44 (0) 1223 891854 Date of Preparation: June 2017 Company Reference: PP-2680


Adverse events should be reported.


Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard and in Ireland they can be found at www.hpra.ie


Adverse events should also be reported to Swedish Orphan Biovitrum Ltd by email: drugsafety@sobi.com


References 1. Xiapex Summary of Product Characteristics. November 2013. 2. Hurst LC, Badalamente MA, Hentz VR et al. N Engl J Med 2009; 361(10):968–79. 3. Peimer CA, et al. J Hand Surg Am. 2015; 40 (8): 1597-1605 4. Warwick D et al. The Journal of Hand Surgery (European Volume) 2014:1-9 DOI: 10.1177/1753193413519926. 5. Mehta S, Belcher HJCR. Journal of Plastic, Reconstructive & Aesthetic Surgery (2014), http://dx.doi.org/10.1016/j.bjps.2013.12.030.


PP-2778 Date of preparation: July 2017 * Clinical improvement was defined as a reduction in contracture of 50% or more from baseline 30 days after the last injection


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