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

Mechanismof Action

XIAFLEX® injection selectively targets collagen found in Dupuytren’s contracture cords1

XIAFLEX® works to help disrupt the cord without requiring an incision1*

Please see the full Prescribing Information, including Medication Guide.


Enzymatic Disruption

Two highly selective microbial collagenases (AUX-I and AUX-II) work together to disrupt types I and III collagen found in the cords without damaging nerves, arteries, or large veins containing type IV collagen.1

Binds

Selects and binds to the collagen molecule

Unwinds

Hydrolyzes the triple helix, exposing peptide bonds2

Lyses

Cleaves the peptide bonds

  • There are no clinical data regarding relative contributions of the individual collagenases to the efficacy of XIAFLEX® in the treatment of Dupuytren’s contracture1
  • In these studies, nonfibrillar type IV collagen was affected, causing collagen lysis in small veins1

*Promptly evaluate signs and symptoms of serious injury to the injected finger/hand, as surgical intervention may be required.1

PatientIdentification

From initial treatment to retreatment, XIAFLEX® is a proven option to offer your appropriate patients1

When there is a palpable cord and a contracture, consider XIAFLEX®1

The only FDA-approved nonsurgical treatment with real-world experience in more than 100,000 adult patients with a palpable cord3*

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

Andy

PIP Contracture

Multiple & Recurrent Contractures/ Surgery Averse

Multiple & Recurrent Contractures

MP Contracture

Actor portrayals.
MP=metacarpophalangeal; PIP=proximal interphalangeal.
*Through May 2017.

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

Improvement in range of motion can occur after first injection4

Get to know a patient with a PIP contracture

ANDY

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

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

*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

Adult patients who prefer a minimally-invasive treatment may be viable candidates for XIAFLEX®5

Improvement in range of motion can occur after first injection4

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

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 2 joints 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.6

§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

Proven efficacy in treating multiple contractures1,6

Improvement in range of motion can occur after first injection4

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

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.6

Patients’ mean range of motion in MP joints nearly doubled with XIAFLEX® treatment7*

Improvement in range of motion can occur after first injection4

Get to know a patient with an MP contracture

John

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

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

*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

Dosing &Reconstitution

There are 3 steps to preparing XIAFLEX® for injection

Every box of XIAFLEX® includes1:

  • 1 single-use glass vial containing 0.9 milligrams of a sterile lyophilized powder for reconstitution
  • 1 single-use glass vial of sterile diluent

Vials should be stored upright in a refrigerator

  • Store from 2°C to 8°C (36°F to 46°F). Do not freeze1

Prepare for reconstitution

  • Let vials stand at room temperature (68°F to 77°F; 20°C to 25°C) for at least 15 minutes and no longer than 60 minutes1
  • Do not use if left at room temperature for more than 60 minutes

TIP

Remove the vials from the box to help them reach room temperature.

Visually inspect the vials before reconstitution1:

  • Cake of lyophilized powder should be intact and white in color1

A syringe is needed for reconstitution (not supplied)

  • Use a new 1-mL syringe with 0.01 mL graduations with a permanently fixed, 27-gauge ½-inch needle containing 0.58 mg of XIAFLEX®1
  • Using aseptic technique (using sterile alcohol to swab surfaces), slowly inject the proper volume of diluent into the sides of the vial containing the lyophilized powder1
    • 0.25 mL for cords affecting an MP joint
    • 0.20 mL for cords affecting an PIP joint

If treating 2 joints on the same hand in a single visit

  • Use separate vials and syringes for each reconstitution and injection1

TIP

Gently swirl the solution to ensure that all of the lyophilized powder has gone into the solution. Do not invert or shake the solution because it can denature the proteins.

Full clinical dose of XIAFLEX®

  • 0.58 mg per injection procedure into each palpable cord1

Up to 2 joints on the same hand may be treated during a single treatment visit1

  • If a patient has other palpable cords with contractures, inject those cords at another treatment visit
Volumes Needed for Reconstitution and Administration
Joints to be treated Sterile diluent
required for reconstitution1
Volume of solution
to deliver
MP Joints 0.39 mL 0.25 mL
PIP Joints 0.31 mL 0.20 mL

Prior to administration

  • Keep reconstituted solution at room temperature for up to 1 hour, or refrigerate for up to 4 hours1
  • If the reconstituted XIAFLEX® solution is refrigerated, allow it to return to room temperature for about 15 minutes before using
  • Inspect solution visually for particulate matter and discoloration prior to use. If the solution contains particulates, is cloudy, or is discolored, it should not be used and should be reported to Endo Pharmaceuticals Inc. by calling 1-800-462-36361
Reconstituted XIAFLEX® Storage
Room temperature
Up to 1 hour
Refrigerated
Up to 4 hours
Celsius 20°- 25° 2°-8°
Fahrenheit 68°-77° 36°-46°

TIP

Prior to injection, ensure there are no air bubbles in the syringe.

For complete dosing and administration for XIAFLEX®, please see the full Prescribing Information, including Medication Guide.

watch preparation video»

ProcedureOverview

Administering XIAFLEX® includes controlled injection into a palpable cord

A finger extension is done ~24–72 hours later to disrupt the cord if necessary1

XIAFLEX® should be administered by a healthcare professional (HCP) experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture.1 To be a trained injector of XIAFLEX®, HCPs must enroll in the XTRA Training Program and complete the required training.

For complete dosing and administration for XIAFLEX®, please see the full Prescribing Information, including Medication Guide.

To become a trained injector, watch the XIAFLEX® training video»

Setting PatientExpectations

Setting expectations with your patients

Prior to their XIAFLEX® treatment, be sure to inform your patients of the potential side effects and post-treatment instructions1

Actual patient ~24–72 hours after XIAFLEX® injection. Swelling and bruising at the injection site are two of the most common side effects of XIAFLEX®

COMMON SIDE EFFECTS INCLUDE:

  • Swelling of the hand or the injection site
  • Bruising or bleeding at the injection site
  • Pain or tenderness of the injection site or the hand
  • Swelling of the lymph nodes in the elbow or armpit
  • Breaks in the skin
  • Redness or warmth of the skin
  • Itching
  • Pain in the armpit

PATIENTS SHOULD CALL YOUR OFFICE IF THEY EXPERIENCE:

  • Signs of infection like fever, chills, or increased redness or swelling
  • Numbness or tingling in the treated finger(s)
  • Increased pain or tears in the skin in the treated finger(s) or hand
  • Trouble bending the injected finger(s) after swelling goes down
  • Symptoms of an allergic reaction, such as hives, swelling in the face, breathing trouble, chest pain, low blood pressure, dizziness, or fainting

Give patients instructions for what they need to do at home1

AFTER INJECTION

  • Keep the hand elevated until bedtime
  • Limit the movement of the treated finger(s)
  • Do not bend or straighten the treated finger(s)

AFTER FINGER EXTENSION

  • Do finger exercises each day as instructed
  • Wear a splint at bedtime to keep the finger(s) straight
  • Resume normal activities using the affected hand only when instructed to do so
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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.


  1. References:
  2. 1. XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.
  3. 2. Chung L, Dinakarpandian D, Yoshida N, et al. Collagenase unwinds triple helical collagen prior to peptide bond hydrolysis. EMBO J. 2004;23(15):3020-3030.
  4. 3. Data on file. DOF-XDC-26. Endo Pharmaceuticals Inc; June 9, 2017.
  5. 4. Data on file. DOF-XDC-22. Endo Pharmaceuticals Inc; January 9, 2017.
  6. 5. Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011;36(5):936-942.
  7. 6. 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. 7. Data on file. DOF-XDC-23. Endo Pharmaceuticals Inc; January 19, 2017.