XIAFLEX® (collagenase clostridium histolyticum) — A nonsurgical option for Dupuytren’s contracture

XIAFLEX^®—an FDA-approved nonsurgical treatment for adults with Dupuytren’s contracture when a “cord” can be felt.

Dupuytren's contracture is a condition caused by a buildup of collagen in the hand. Over time, it can form a rope-like cord under the skin that causes fingers to bend toward the palm so they can't be straightened.

To treat Dupuytren's contracture, XIAFLEX^® is injected into the “cord” that can be felt. While the mechanism is not fully known, XIAFLEX^® is thought to attach to the collagen that makes up the cord, unwinding it and eventually breaking it down.

Nonsurgical XIAFLEX^® is administered in a doctor's office and requires no general anesthesia. The XIAFLEX^® procedure can only be given by a Hand Specialist trained to use XIAFLEX^®.

A Hand Specialist may consider treatment with XIAFLEX^® if you have a cord that can be felt, along with:

• Contractures ranging from less severe to more severe^§
• Multiple contractures in 1 hand. Up to 2 cords in 1 hand may be treated during 1 office visit
• Contractures that have come back. Dupuytren’s contracture may come back no matter what treatment option you use. If your condition returns after treatment, nonsurgical XIAFLEX^® may be used again

Studies show that prescription XIAFLEX^®, along with a finger extension procedure, may help straighten or nearly straighten the affected finger and improve range of motion after up to 3 injections.

XIAFLEX^® can cause serious side effects such as tendon rupture or ligament damage.

XIAFLEX^® has a $0 copay for most eligible patients with commercial insurance plans through the XIAFLEX^® Copay Assistance Program.^*

^*Based on analysis of claims filed September 2011 through March 2018.

^§In clinical trials, XIAFLEX^® was used to treat metacarpophalangeal joint contractures of 20-100° or proximal interphalangeal joint contractures of 20-80°

IMPORTANT SAFETY INFORMATION FOR XIAFLEX

Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX. See Important Safety Information below.

What Kind of Results Are Possible?

Individual results may vary. The following are real-world examples of treatment with XIAFLEX^®:

The patient shown above had a cord that could be felt, causing a contracture of the MP (metacarpophalangeal) joint of the left ring finger. The cord was injected with XIAFLEX^®, and a finger extension procedure was performed 48 hours later.

The patient shown above had a cord that could be felt, causing a contracture of the MP and PIP (proximal interphalangeal) joints of the left pinky finger. The cord was injected with XIAFLEX^® at each location, and a finger extension procedure was performed for each joint 48 hours later.­­

These patients had finger extensions performed by a physician; were fitted with a splint; and were instructed to use a splint at bedtime for up to 4 months and perform daily finger exercises.

In studies, patients received up to 3 injections of XIAFLEX^® or placebo into a cord that could be felt at approximately 4-week intervals.

The most common side effects with XIAFLEX^® for the treatment of Dupuytren’s contracture include swelling of the injection site or the hand; bruising or bleeding at the injection site; pain or tenderness of the injection site or the hand; swelling of the lymph nodes (glands) in the elbow or armpit; itching; breaks in the skin; redness or warmth of the skin; and pain in the armpit.

If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX^®. For more information, ask your healthcare provider or pharmacist.

Find a Hand Specialist

Hear From Patients Like You

Since 2010, it is estimated that more than 190,000 adult patients with Dupuytren’s contracture have been prescribed XIAFLEX^®.^†  Watch a few of their stories.

^†From February 2010 through May 2022.

IMPORTANT SAFETY INFORMATION FOR XIAFLEX (collagenase clostridium histolyticum)

WHAT IS XIAFLEX^®?

XIAFLEX is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt. It is not known if XIAFLEX is safe and effective in children under the age of 18.

IMPORTANT SAFETY INFORMATION FOR XIAFLEX

Do not receive XIAFLEX if you have had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

• Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit
• Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit
• Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:
  • hives
  • swollen face
  • breathing trouble
  • chest pain
  • low blood pressure
  • dizziness or fainting

• Fainting. Fainting (passing out) or near fainting can happen in people who receive XIAFLEX, especially following finger procedures
  If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.

• Increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines if you are unsure.

The most common side effects with XIAFLEX for the treatment of Dupuytren’s contracture include:

• swelling of the injection site or the hand
• bruising or bleeding at the injection site
• pain or tenderness of the injection site or the hand
• swelling of the lymph nodes (glands) in the elbow or armpit
• itching
• breaks in the skin
• redness or warmth of the skin
• pain in the armpit

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist.

Click for full Prescribing Information, including Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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XIAFLEX^® is a registered trademark of Endo International plc or one of its affiliates.

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