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

WELCOME TO THE XTRA PROGRAM
The XIAFLEX® Training Resources for Administration (XTRA) Program provides physicians and their offices access to all existing injector training, resources, and information about the managed distribution enrollment needed to get started with XIAFLEX®.

XIAFLEX® PROCEDURE TRAINING VIDEO

Only physicians who have completed the necessary training and enrollment can inject XIAFLEX®

Self Test

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Preparation

Where Innovation meets technique

Question 1 of 2

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Before use, for how long should the vials containing XIAFLEX® and the diluent be left to stand at room temperature?

Question 2 of 2

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Fill in the blanks: When reconstituting XIAFLEX®, use ____ mL of sterile diluent for an MP joint and _____ mL of sterile diluent for a PP joint.

Self Test

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Injection Procedure

Where Innovation meets technique

Question 1 of 3

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The proper site of injection for XIAFLEX® is:

Question 2 of 3

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The amount of reconstituted XIAFLEX® that should be injected at each location along the cord is:

Question 3 of 3

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When injecting XIAFLEX®, it is important to:

Self Test

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Finger Extension Procedure

Where Innovation meets technique

Question 1 of 3

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What is the maximum number of attempts that should be made to disrupt the cord during the follow-up visit?

Question 2 of 3

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Injections and finger extension procedures may be administered up to ___ times per cord, at approximately 4-week intervals.

Question 3 of 3

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What should patients be instructed to do following the finger extension procedure?

XIAFLEX® managed distribution program

XIAFLEX® managed distribution program

  • Only enrolled, qualified physicians have access to XIAFLEX®
  • Only enrolled healthcare sites may receive XIAFLEX® orders

How to become a trained injector

Download a PDF training guide

Physicians are required to view the training and safety materials.

FREQUENTLY ASKED QUESTIONS

What is the proper place to position the needle for the injection procedure?

To determine the proper site for injection, locate the area where the contracting cord is maximally separated from the underlying flexor tendons, and where the skin is not intimately adhered to the cord.1
For complete details on the appropriate injection procedure for XIAFLEX®, visit the Dosing & Administration page.

Can anesthesia be used with XIAFLEX®?

Use of local anesthetic is not recommended prior to the injection procedure, as it may interfere with proper placement of the needle.1
However, local anesthetic may be used for the finger extension procedure to help with patient comfort.1
To learn more about the appropriate administration of XIAFLEX®, visit the Dosing & Administration page.

When should the finger extension procedure be performed?

The finger extension procedure may be performed ~24 to 72 hours after the injection of XIAFLEX® if a contracture persists.1
Read more about performing the finger extension procedure on the Dosing & Administration page.

Can XIAFLEX® be used for severe PIP contractures?

Yes. In fact, XIAFLEX® demonstrated efficacy in patients with PIP contractures up to 80 degrees.1
Learn more about how XIAFLEX® helped correct contractures and increased range of motion in PIP and MP joints on the Clinical Data page.

What is the process for acquiring XIAFLEX®?

Only physicians who have completed the necessary training and enrollment can obtain and inject XIAFLEX®. Once a practice is enrolled in the managed distribution program, there are 2 ways to acquire XIAFLEX®—via a Specialty Distributor (Besse Medical) or a Specialty Pharmacy (US Bioservices).
For more information on the acquisition process, go to the Acquiring XIAFLEX® page.

INTEGRATING XIAFLEX® INTO YOUR PRACTICE

Once you have completed the procedure training and enrolled in the XIAFLEX® managed distribution program, your practice is ready to schedule appropriate adult patients with Dupuytren’s contracture with a palpable cord to be treated with XIAFLEX®.

Consider the following for integrating XIAFLEX® into your practice:

Identification of patients

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

Obtaining XIAFLEX®

  • There are 2 options for obtaining XIAFLEX® (subject to payor requirements)
    • BUY-AND-BILL:
      Purchase XIAFLEX® from a Specialty Distributor and receive reimbursement from the payor after XIAFLEX® is administered.
    • SPECIALTY PHARMACY:
      Obtain XIAFLEX® through a Specialty Pharmacy, which will bill the payor for XIAFLEX® based on a patient's insurance plan.

Supplies and product storage

  • XIAFLEX® is supplied as a sterile, lyophilized powder (white cake) in single-use, glass vials containing 0.9 mg of collagenase clostridium histolyticum1
  • XIAFLEX® must be reconstituted with the provided sterile diluent prior to use1
  • Prior to reconstitution, both XIAFLEX® lyophilized powder and sterile diluent should be kept refrigerated at 2°C–8°C (36°F–46°F)1
  • XIAFLEX® is administered using a 1-mL hubless syringe that contains 0.01 mL graduations with a 27-gauge 0.5-inch needle (not supplied)1
  • A separate 1-mL syringe that contains 0.01 mL graduations with a 27-gauge 0.5-inch needle (not supplied) is used for reconstitution1

Patient scheduling

Schedule initial visit for the injection and follow-up visit for the finger extension procedure if the contracture persists ~24–72 hours later.1

  • Determine follow-up visits. Be sure to schedule all anticipated patient treatment visits in advance, as needed. Inject up to 2 cords in the same hand at a treatment visit. If a patient has other cords with MP or PIP contractures, inject those cords at other treatment visits approximately 4 weeks apart

Reimbursement

See More

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.  Starkweather KD, Lattuga S, Hurst LC, et al. Collagenase in the treatment of Dupuytren’s disease: an in vitro study. J Hand Surg Am. 1996;21(3):490-495.
3.  Data on file. DOF-XDC-18. Endo Pharmaceuticals Inc; July 24, 2015.
4.  Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011;36(5):936-942.
5.  Brandt KE. An evidence-based approach to Dupuytren’s contracture. Plast Reconstr Surg. 2010;126(6):2210-2215.
6.  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.