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Treatment for adults with Dupuytren's
contracture with a palpable cord
Hand with Dupuytren's Contracture

RECURRENCE
Dupuytren's contracture is a chronic, progressive fibroproliferative disease with no available cure, and contractures can recur following all currently available treatment modalities.9-11

Recurrence of a palpable cord can occur regardless of previous treatment9

It’s time to examine when to use XIAFLEX® in the treatment of appropriate adult patients

  • In clinical trials, XIAFLEX® was evaluated in patients who had previously had hand surgery where contracture recurred, as well as in patients who had not received prior treatment1,5
    • In CORD I and II, 38% and 53% of patients had prior surgery to treat Dupuytren's contracture, respectively

Retreatment of recurrent contractures following initial treatment with XIAFLEX®

  • A long-term, observational, Year 2 to Year 5 follow-up study recurrence of contracture and long-term safety in 645 patients who received up to 8 single injections of XIAFLEX® 0.58 mg in a previous Phase 3 open-label or double-blind with open-label extension study. A subset of these patients (N=52) was retreated with up to 3 injections of XIAFLEX® 0.58 mg in a recurrent joint that was previously successfully treated (ie, contracture reduction to ≤5° at the Day 30 visit after the last XIAFLEX® injection in previous study)1
    • In recurrent joints, 65% (20/31) of MP and 45% (9/20) of PIP joints achieved clinical success* after retreatment with up to 3 injections of XIAFLEX®1†
    • No new safety signals were identified among patients who were retreated with XIAFLEX®1

*Clinical success was defined as a reduction in contracture to 0°–5° 30 days after last XIAFLEX® injection.1,12

Recurrence was defined as an increase in joint contracture by ≥20° in the presence of a palpable cord or the joint underwent medical or surgical intervention primarily to correct a new or worsening contracture in that joint.1

Consider XIAFLEX® for your appropriate adult patients' initial treatment and retreatment
of Dupuytren's contracture with a palpable cord1

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Important Safety Information for XIAFLEX®

  • XIAFLEX® is contraindicated in patients with a history of hypersensitivity to XIAFLEX® or to collagenase used in any other therapeutic application or application method
  • In the controlled and uncontrolled portions of clinical trials in Dupuytren's contracture, flexor tendon ruptures occurred after XIAFLEX® injection. Injection of XIAFLEX® into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX® should be injected only into the collagen cord with a MP or PIP joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion should not be more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease
  • Other XIAFLEX®-associated serious local adverse reactions in the controlled and uncontrolled portions of the studies included pulley rupture, ligament injury, complex regional pain syndrome (CRPS), sensory abnormality of the hand, and skin laceration (tear). In a historically controlled post-marketing trial, the incidence of skin laceration (22%) was higher for subjects treated with two concurrent injections of XIAFLEX® compared with subjects treated with up to three single injections in the placebo-controlled premarketing trials (9%). 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 injected finger/hand should be promptly evaluated because surgical intervention may be required
  • In the controlled portions of the clinical trials in Dupuytren's contracture, a greater proportion of XIAFLEX®-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX®-associated pruritus increased after more XIAFLEX® injections in patients with Dupuytren's contracture
  • Because XIAFLEX® contains foreign proteins, severe allergic reactions to XIAFLEX® can occur. Anaphylaxis was reported in a post-marketing clinical study in one patient who had previous exposure to XIAFLEX® for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX® injections
  • In the XIAFLEX® trials in Dupuytren's contracture, 70% and 38% of XIAFLEX®-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX® in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX® administration is not known. In addition, it is recommended to avoid use of XIAFLEX® in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
  • In the XIAFLEX® clinical trials for Dupuytren's contracture, the most common adverse reactions reported in ≥25% of patients treated with XIAFLEX® and at an incidence greater than placebo were edema peripheral (eg, swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity

INDICATION

XIAFLEX® is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.

Please see the full Prescribing Information, including Medication Guide.

References:

1.  XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.
2.  Raven RB 3rd, Kushner H, Nguyen D, Naam N, Curtin C. Analysis of efficacy and safety of treatment with collagenase clostridium histolyticum among subgroups of patients with Dupuytren contracture. Ann Plast Surg. 2014;73(3):286-290.
3.  Hurst LC, Badalamente MA, Hentz VR, et al; for CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009;361(10):968-979.
4.  Data on file. DOF-XDC-07. Endo Pharmaceuticals Inc; July 29, 2015.
5.  Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren’s disease. J Hand Surg Am. 2010;35(12):2027-2038.
6.  Data on file. DOF-XDC-08. Endo Pharmaceuticals Inc; July 24, 2015.
7.  Gaston RG, Larsen SE, Pess GM, et al. The efficacy and safety of concurrent collagenase clostridium histolyticum injections for 2 Dupuytren contractures in the same hand: a prospective, multicenter study. J Hand Surg Am. 2015;40(10):1963-1971.
8.  Data on file. DOF-XDC-03. Endo Pharmaceuticals Inc; July 21, 2015.
9.  Hay DC, Louie DL, Earp BE, Kaplan FT, Akelman E, Blazar PE. Surgical findings in the treatment of Dupuytren’s disease after initial treatment with clostridial collagenase (Xiaflex). J Hand Surg Eur Vol. 2014;39(5):463-465.
10.  Syed F, Thomas AN, Singh S, Kolluru V, Emeigh Hart SG, Bayat A. In vitro study of novel collagenase (XIAFLEX®) on Dupuytren’s disease fibroblasts displays unique drug related properties. PLoS One. 2012;7(2):e31430.
11.  Townley WA, Baker R, Sheppard N, Grobbelaar AO. Dupuytren’s contracture unfolded. BMJ. 2006;332(7538):397-400.
12.  Data on file. DOF-XDC-09. Endo Pharmaceuticals Inc; June 10, 2015.