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

Learn more about the distinct mechanism of action of XIAFLEX®, which patients might be right for XIAFLEX®, and dosing and administration.

XIAFLEX® OPERATES DIFFERENTLY with a distinct mechanism of action

Injection of XIAFLEX® may result in enzymatic disruption of the collagen in the Dupuytren’s cord1-3

  • Results of in vitro studies, including those of explant tissues containing Dupuytren’s cords, suggest that XIAFLEX® disrupts the predominant collagen found in cords (types I and III)1-3
  • In these studies, nonfibrillar type IV collagen was affected, causing collagen lysis in small veins. XIAFLEX® did not cause damage to the following structures containing type IV collagen1,4:
    • Nerves
    • Arteries
    • Large veins
  • Collagen disruption is thought to occur in a 3-step process. A collagenase5*:
    • Binds: selects and binds to the collagen molecule
    • Unwinds: hydrolyzes the triple helix, exposing peptide bonds
    • Lyses: cleaves the peptide bonds

* There are no clinical data regarding relative contributions of the individual collagenases (AUX-I or AUX-II) to the efficacy of XIAFLEX® in the treatment of Dupuytren’s contracture.1

Patient Identification

  • XIAFLEX® is a minimally invasive treatment option that may be appropriate for a broad range of adults with a palpable cord1
    • Patients with 20°–100° MP joint contractures
    • Patients with 20°–80° PIP joint contractures
    • Patients who have had prior surgery (fasciectomy or fasciotomy)
    • Patients who are unwilling to undergo surgery
    • Patients with palpable Dupuytren's cords affecting 2 joints in the same hand
  • Allows you to preserve surgical options for your patients1,6-8

Flexibility with multiple FDA-approved administration options

  • Palpable cords affecting 1 or 2 joints on the same hand can be treated in 1 office visit1
  • 2 palpable cords affecting 2 joints may be injected or 1 palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit, including the following patient types9*:
    • 1 MP joint and 1 PIP joint on the same finger
    • 2 MP joints on the same hand, different fingers
    • 2 PIP joints on the same hand, different fingers
    • 1 MP joint and 1 PIP joint on the same hand, different fingers
  • For patients with additional MP or PIP contractures with palpable cords in the same hand, these can be injected during subsequent office visits approximately 30 days apart1
  • Scheduling flexibility for patients and physicians’ offices1
    • Finger extension procedure may be performed ~24–72 hours after injection*

* Injection and finger extension may be performed up to 3 times per cord at approximately 30-day intervals, if needed.1

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XIAFLEX® is appropriate for a range of patients

View profiles of patients with Dupuytren’s contracture like ones you may see in your practice

Actor portrayals.

Since 2010, it is estimated that
more than 100,000 patients
have been treated with XIAFLEX®10*

* Through May 2017. Includes patients receiving initial and recurrent treatment.

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Proven efficacy with improved mean range of motion in PIP joints1*

Improvement in range of motion can occur after first injection11

Get to know a patient with a PIP contracture

Andy

  • 59 years old
  • Pastry chef
  • Enjoyed playing guitar before his contracture worsened

Before Treatment

Presentation

  • Father and brother both previously diagnosed with Dupuytren’s contracture
  • PIP contracture on fifth finger of left hand
  • Had surgery 4 years ago but contracture recurred

Assessment

  • PIP contracture with a palpable cord
  • Range of motion limited to 45°
  • Significant progression in recent months
  • Hand specialist recommended XIAFLEX®

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 crease1


* Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

One treatment cycle is injection of palpable cord with finger extension ~24–72 hours later. Injection and finger extension may be performed up to 3 times per cord at approximately 30-day intervals, if needed.1

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ADULT PATIENTS WHO PREFER A MINIMALLY-INVASIVE TREATMENT MAY BE VIABLE CANDIDATES FOR XIAFLEX®6

Improvement in range of motion can occur after first injection11

Get to know a surgery-averse patient with multiple contractures with palpable cords

Marilyn

  • 64 years old
  • Yoga instructor
  • Taught sign language classes before her contractures worsened

Before Treatment

Presentation

  • 3-year history of MP contracture on fourth finger of left hand
  • Previously treated with needle aponeurotomy
  • MP contracture recurred after 1 year, along with a PIP contracture on fourth finger of left hand

Assessment

  • 45° MP contracture with a palpable cord and a 23° PIP contracture with a palpable cord
  • Decreased range of motion
  • Patient prefers not to undergo a second needle aponeurotomy or surgery

* Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

In the trial, 65% of MP joints and 29% of PIP joints were successfully treated. Clinical success was defined as reduction in contracture to ≤5° at Day 31 after 2 concurrent injections in the same hand.9

§ One treatment cycle is injection of palpable cord with finger extension ~24–72 hours later. Injection and finger extension may be performed up to 3 times per cord at approximately 30-day intervals, if needed.1

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Proven efficacy in treating multiple contractures1,9

Improvement in range of motion can occur after first injection9

Get to know a patient with multiple and recurrent contractures

Frank

  • 63 years old
  • Travels to a different country with his wife every summer
  • Teacher
  • Enjoyed woodworking before his contractures worsened

Before Treatment

Presentation

  • Family history of Dupuytren’s contracture
  • Previously had Dupuytren’s contractures on fourth and fifth fingers
  • 2 prior recurrences in same location with surgery 10 and 20 years ago
  • 5-year progressive return of PIP contracture on fourth finger of left hand and MP contracture on fifth finger

Assessment

  • 50° PIP contracture with a palpable cord on fourth finger
  • 65° MP contracture with a palpable cord on fifth finger
  • Decreased range of motion
  • 2 cords in the same hand led hand specialist to recommend XIAFLEX®1

* In the trial, 65% of MP joints and 29% of PIP joints were successfully treated. Clinical success was defined as a reduction of contracture to ≤5° at Day 31 after 2 concurrent injections in the same hand.9

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Patients’ mean range of motion in MP joints nearly doubled with XIAFLEX® treatment1*

Improvement in range of motion can occur after first injection11

Get to know a patient with MP contracture

John

  • 67 years old
  • Likes to fish with his grandson
  • Attorney
  • Avid golfer before his Dupuytren’s contracture worsened

Before Treatment

Presentation

  • 5-year history of MP contracture on fourth finger of left hand
  • Contracture measured 20° at first visit with primary care physician 4 years ago
  • Primary care physician suggested watchful waiting

Assessment

  • 40° MP contracture with a palpable cord on ring finger
  • Decreased range of motion
  • John worried that the potential recovery time and risk of infection from surgery might interfere with his upcoming family vacation
  • Hand specialist recommended XIAFLEX®

* Patients may have received up to 3 injections of study medication into the cords associated with contracture of the primary joints on Days 0, 30, and 60. Assessments were made 30 days after the last injection (on Days 30, 60, or 90).1

XIAFLEX®-treated patients received a mean of 1.7 injections in the 90-day controlled period in each clinical trial.1

One treatment cycle is injection of palpable cord with finger extension ~24–72 hours later. Injection and finger extension may be performed up to 3 times per cord at approximately 30-day intervals, if needed.1

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Dosing & Administration Summary

XIAFLEX® should be administered by a healthcare professional (HCP) experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture. To be a trained injector of XIAFLEX®, HCPs must enroll in the XTRA Program and complete the required training.

Please see the full Prescribing Information for complete Dosage and Administration information.

Reconstitution

A 1-mL syringe is needed for XIAFLEX® reconstitution.1

The syringe should contain 0.01-mL graduations with a 27-gauge, ½-inch needle.1

Reconstitute XIAFLEX® lyophilized powder only with the supplied diluent prior to use.1

Note: A separate, new 1-mL hubless syringe that contains 0.01-mL graduations with a permanently fixed, 27-gauge, ½-inch needle is needed for administration. If 2 joints on the same hand are to be treated during a single treatment visit, separate vials and syringes should be used for each reconstitution and injection.

Dosing

The full clinical dose of XIAFLEX® is 0.58 mg per injection procedure into each palpable Dupuytren's cord with contracture affecting the MP or PIP joint.1

Up to 2 joints in the same hand may be treated during a single treatment visit.1

If a patient has other palpable cords with MP or PIP contractures, inject those cords at other treatment visits approximately 4 weeks apart.

Note: The entire reconstituted XIAFLEX® solution contains 0.9 mg of XIAFLEX®. Reconstituted XIAFLEX® solution remaining in the vial after the injection should be discarded.

* Use diluent vial provided in package containing 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride USP.

Administering XIAFLEX® involves a controlled injection into a palpable cord, followed by a finger extension process to facilitate cord disruption if necessary1

INJECTION PROCEDURE1†:

  • Each vial of XIAFLEX® and sterile diluent should only be used for a single injection
    • If 2 joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection1
  • The full clinical dose of 0.58 mg should be injected into each palpable cord. XIAFLEX® is injected in 3 locations of the cord during each injection procedure as noted in the XIAFLEX® Prescribing Information
    • For 2 contractures on 1 hand, start with the fifth finger and work toward the index finger
    • For 2 contractures in the same finger, start with MP and then move up to PIP
  • Administer up to 2 injections in the same hand during a treatment visit according to the injection procedure noted in the XIAFLEX® Prescribing Information
    • 2 palpable cords affecting 2 joints may be injected
    • 1 palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit
    • If a patient has additional palpable cords with contractures of MP or PIP joints, these can be treated with XIAFLEX® at additional treatment visits approximately 30 days apart

FINGER EXTENSION PROCEDURE1†:

  • At the follow-up visit, ~24–72 hours after injection(s), if a contracture remains, perform a finger extension procedure to facilitate a cord disruption
  • If 2 joints in 1 finger were treated, perform the finger extension procedure on the affected MP joint before performing the finger extension procedure on the affected PIP joint
  • Following the finger extension procedure(s), fit patient with a splint and provide instructions for use at bedtime for up to 4 months to maintain finger extension
  • Instruct the patient to perform finger extension and flexion exercises several times a day for several months

Injection and finger extension may be performed up to 3 times per cord at approximately 30-day intervals, if needed.1

Please see the full Prescribing Information for complete Dosage and Administration information.

For your appropriate adult patients with Dupuytren's contracture with a palpable cord, consider XIAFLEX®, the only FDA-approved treatment option that can be performed in your office1

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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.  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; September 14, 2015.
4.  Watt AJ, Hentz VR. Collagenase clostridium histolyticum: a novel nonoperative treatment for Dupuytren's disease. Int J Clin Rheumatol. 2011;6(2):123-133.
5.  Hart SE. A primer of collagen biology: synthesis, degradation, subtypes, and role in Dupuytren’s disease. In: Eaton C, Seegenschmiedt MH, Bayat A, Gabbiani G, Werker PMN, Wach W, eds. Dupuytren’s Disease and Related Hyperproliferative Disorders: Principles, Research, and Clinical Perspectives. 1st ed. London, England: Springer; 2012:131-142.
6.  Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011;36(5):936-942.
7.  Brandt KE. An evidence-based approach to Dupuytren’s contracture. Plast Reconstr Surg. 2010;126(6):2210-2215.
8.  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.
9.  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.
10.  Data on file. DOF-XDC-26. Endo Pharmaceuticals Inc; June 9, 2017.
11.  Data on file. DOF-XDC-22. Endo Pharmaceuticals Inc; January 9, 2017.