Mechanism of Action

XIAFLEX® is a combination of 2 types of collagenase (AUX-I and AUX-II) that appear to work synergistically to provide hydrolyzing activity on collagen in the palpable cord.1

Injection of XIAFLEX into a Dupuytren's cord, which is composed mostly of collagen, may result in enzymatic disruption of the cord.1

Important Safety Information

Tendon rupture or other serious injury to an injected extremity can occur with XIAFLEX. XIAFLEX should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture.

Video 1 of $n

Please see full and .

What is XIAFLEX®?

XIAFLEX is the only FDA-approved minimally invasive treatment option for adult patients with Dupuytren’s contracture with a palpable cord.

USED IN A BROAD RANGE OF CONTRACTURE SEVERITIES:

  • XIAFLEX has shown to be efficacious in clinical trials, including the largest placebo-controlled clinical trial for Dupuytren’s contracture1-3

  • Treatment with XIAFLEX is an office-based procedure that does not require an incision to administer1

Important Safety Information

  • XIAFLEX is contraindicated in patients with a history of severe allergic reaction 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), and sensory abnormality of the hand

  • 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. Although there were no severe allergic reactions observed in the XIAFLEX clinical studies (eg, those associated with respiratory compromise, hypotension, or end-organ dysfunction), an anaphylactic reaction was reported in a post-marketing clinical study in a patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture, demonstrating that severe reactions including anaphylaxis can occur following XIAFLEX injections. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known

  • 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

Please see full Prescribing Information and Medication Guide.

References

  1. XIAFLEX [package insert]. Auxilium Pharmaceuticals Inc.; 2012.
  2. Hurst LC, Badalamente MA, Hentz VR, et al; for CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl Med. 2009;361(10):968-979.
  3. Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase clostridium histolyticum: a new nonsurgical treatment for Dupuytren's diseases. J Hand Surg Am. 2010;35(12):2027-2038.
This site is intended for
US healthcare providers only.
Visit the patient website.
Mail Print page Receive Updates Request a Rep Find a Specialist Important Safety Information