Xiaflex (Collagenase Clostridium histolyticum) - Injection

Warning:

Serious side effects are possible with Xiaflex (Collagenase Clostridium histolyticum). For this reason, the Food and Drug Administration (FDA) has a Risk Evaluation and Mitigation Strategy in place for Xiaflex to help make sure it's appropriate for people at risk for tearing of tendons or serious reactions (e.g., anaphylaxis). Using Xiaflex for Peyronie’s disease is linked to a hematoma (bad bruise) and penile fracture (broken penis). A penile fracture is a rare but emergency situation. When a penile fracture occurs, you may hear a loud popping or cracking sound as your erect penis hits a blunt force or object. Another symptom of a penile fracture includes an immediately limped penis that's bruised and swollen. If you suspect that you're experiencing symptoms of a hematoma or penile fracture, get medical help right away.

What Is Xiaflex?

Xiaflex (collagenase Clostridium histolyticum) is a treatment option for Dupuytren’s contracture (tightening of tissue in the hand) and Peyronie’s disease (tissue scarring after an injury to the penis).

Xiaflex is a biologic medication that has a group of two collagenases. Biologic medications are made from living things. In this case, these collagenases are proteins that come from Clostridium histolyticum bacteria.

Xiaflex works by breaking down collagen to relieve symptoms in Dupuytren’s contracture and Peyronie’s disease. Collagen is a connective tissue protein that's in tendons and muscles. Connective tissues provide support to many parts of your body, including bones and skin. In both Dupuytren’s contracture and Peyronie’s disease, a build-up of collagen takes place in the body.

Xiaflex is available as a prescription injection during an office visit with your healthcare provider.

Drug Facts

Generic Name: Collagenase Clostridium histolyticum

Brand Name: Xiaflex

Drug Availability: Prescription

Therapeutic Classification: Collagenase (enzyme or protein that breaks down collagen)

Available Generically: No

Controlled Substance: N/A

Administration Route: Injection

Active Ingredient: Two collagenases from Clostridium histolyticum bacteria

Dosage Form: Powder mixed with a sterile liquid to turn into a solution

What Is Xiaflex Used For?

Xiaflex is used to treat Dupuytren's contracture (tightening of tissue in the hand) and Peyronie's disease (tissue buildup in the penis after injury).

In Dupuytren's contracture, there is a build-up of collagen underneath the skin of the palm of your hand. While this build-up isn't painful, it makes it difficult to straighten one or more of your fingers. The cause of this condition is unknown. Some possible risk factors, however, may include:

In Peyronie's disease, the build-up of collagen is inside the penis. This build-up results in a curved penis. The curved penis can make sex painful and difficult. Peyronie's disease is thought to be caused by an injury to your penis. Peyronie's disease can be due to small injuries to the penis over time from vigorous sexual or nonsexual activities. Peyronie's disease may also be more common in people over 55.

Other risk factors for this condition may also include:

  • Autoimmune conditions—like lupus—where your immune system attacks parts of your body by mistake
  • Connective tissue conditions—like Ehlers-Danlos syndrome—a genetic condition with weakened connective tissues with symptoms that include loose joints
  • Diabetes
  • Erectile dysfunction (ED)
  • Genetic risk
  • History of surgery to treat prostate cancer

How to Take Xiaflex

To receive Xiaflex, you'll need to see your healthcare provider. The following are additional details on what to expect during your office visits.

Dupuytren's contracture

  1. During your office visit, the healthcare provider will inject Xiaflex into the affected joints that have a build-up of collagen. The healthcare provider can only inject up to two joints for each hand during an office visit.
  2. When you get home, try to limit movement in the treated fingers. Also, keep the treated hand elevated at bedtime.
  3. If you still have trouble straightening your fingers one to three days after your Xiaflex injections, your healthcare provider will try to straighten them for you.
  4. When you get home, you will need to wear a splint at bedtime for up to four months. You'll also need to perform some finger exercises.
  5. If necessary, your healthcare provider can inject Xiaflex in the same joint up to three times—with four-week gaps in between each injection.

Peyronie's disease

  1. During your office visit, your healthcare provider might inject another medication called alprostadil. Alprostadil is an injection that may help you have an erection. This will help your healthcare provider find the target area with collagen build-up.
  2. Once your penis is flaccid (no longer having an erection), your healthcare provider will inject Xiaflex in the target area.
  3. One to three days after the initial injection, you will return to the office for another Xiaflex injection in the same target area.
  4. One to three days after the second injection, you will return to the office again. At this visit, your healthcare provider will perform a penile modeling procedure to bend your penis in the opposite direction of the curvature.
  5. You'll need to perform your penile modeling activities every day for six weeks when you get home. One of the activities will include using gentle force to stretch your flaccid penis three times daily. Another activity includes straightening your penis during an erection and holding it for 30 seconds once daily. For both activities, use enough force that doesn't cause any pain. Don't have sex until a minimum of four weeks after the second injection—make sure that you also no longer have any bruising or swelling. A treatment cycle is considered steps two through five.
  6. If necessary, your healthcare provider can perform up to four treatment cycles—with six-week gaps in between each cycle.

Storage

You can only receive Xiaflex during office visits with your healthcare provider. Therefore, you don't need to worry about how to store the medication or how to travel with it.

Off-Label Uses

Currently, Xiaflex has no off-label uses.

How Long Does Xiaflex Take to Work?

How long Xiaflex takes to work will vary per person. Your healthcare provider will regularly follow up while you're receiving Xiaflex. If necessary, your healthcare provider will offer you more treatment sessions.

What Are the Side Effects of Xiaflex?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects with Xiaflex for Dupuytren's contracture include:

  • Bruising
  • Injection site reaction
  • Injection site bleeding
  • Pain in your treated arm
  • Swelling in your injected hand

For the treatment of Peyronie's disease with Xiaflex, common penis-related side effects might include:

  • Bleeding
  • Pain
  • Swelling

Severe Side Effects

Severe side effects are possible with Xiaflex. Get medical help right away if you have the following serious side effects:

  • Severe allergic reaction: If you have a severe allergic reaction to Xiaflex, you might have breathing difficulties, dizziness or fainting, and hives. Seek medical attention immediately.
  • Tendon rupture: Xiaflex may damage, break, and weaken your hand's tendon or ligament connective tissues. After receiving Xiaflex, you might experience some swelling. After the swelling goes away, let your healthcare provider know right away if you have symptoms like not being able to bend your fingers toward your wrist or use your treated hand.
  • Other serious hand-related injuries: Xiaflex is also linked with a risk of skin tears or skin necrosis (death). Symptoms in your treated hand may include numbness or tingling sensation, tears in your skin, and worsening pain.
  • Penile fracture or other serious penis-related injuries: Using Xiaflex for Peyronie’s disease is linked to a hematoma (bad bruise) and penile fracture (broken penis). When a penile fracture occurs, you may hear a loud popping or cracking sound as your erect penis hits a blunt force or object. Another symptom of a penile fracture includes an immediately limped penis that's bruised and swollen.
  • After-injection back pain: After receiving Xiaflex, you might experience severe lower back pain that moves to your legs, feet, arms, and chest. Symptoms may also include back spasms and walking difficulties. While these symptoms typically go away within 15 minutes, they may last longer.

Long-Term Side Effects

Many of Xiaflex's severe side effects are also its potential long-term side effects.

Report Side Effects

Xiaflex may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or call the FDA by phone (800-332-1088).

Dosage: How Much Xiaflex Should I Take?

Your healthcare provider will determine and administer your dosage of Xiaflex.

Modifications

Your healthcare provider might slightly modify (change) your Xiaflex treatment under the following situations:

Pregnant parents: There are limited safety and effectiveness data about Xiaflex in pregnant parents. Animal studies suggest a low chance for negative effects on the unborn fetus, but use Xiaflex with caution during pregnancy. Talk with your healthcare provider to weigh the benefits and risks of using Xiaflex while pregnant.

Nursing parents: It's unknown if Xiaflex is present in breastmilk. Since many medications tend to be present in breastmilk, use caution with Xiaflex while nursing. If you have any questions or concerns about using Xiaflex while nursing, reach out to your healthcare provider.

Missed Dose

Xiaflex is a medication that's only injected during office visits. At some of your appointments, your healthcare provider may also help straighten your finger or perform a penile modeling procedure.

If you miss any of your appointments, reach out to your healthcare provider to reschedule as soon as possible.

In between some of your appointments, your healthcare provider will probably recommend at-home finger exercises (Dupuytren's contracture) and penile modeling activities (Peyronie's disease).

Try to find ways to keep your appointments and routinely perform the recommended exercises and activities. You may delay treatment of your Dupuytren's contracture condition or Peyronie's disease if you miss too many appointments or forget to do your exercises or activities.

Overdose: What Happens If I Take Too Much Xiaflex?

Xiaflex's prescribing information didn't include a lot of overdose-related details. If you received too much Xiaflex, however, you might experience more severe side effects at your injection site. You may also have a higher chance of serious side effects, such as tendon rupture or penile fracture.

If you suspect that you're experiencing life-threatening side effects, seek immediate medical attention.

What Happens If I Overdose on Xiaflex?

If you think you or someone else may have overdosed on Xiaflex, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Xiaflex, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you are receiving this medicine for Dupuytren's contracture:

  • Using this medicine may cause injury to the blood vessels, tendons, or ligaments of the hand. Tell your doctor right away if you have pain or numbness in your hand or arm, tears in the skin of your treated finger or hand, trouble bending the finger after the swelling goes down, or bleeding at the injection site.
  • This medicine may cause infection. Tell your doctor right away if you have a fever, chills, or increasing redness or swelling of your hand.

If you are receiving this medicine for Peyronie's disease:

  • This medicine may cause penile fracture (corporal fracture) or other serious injury to the penis. It may damage the tubes in your penis (corpora) during erection after receiving this medicine. Call your doctor right away if you have the following symptoms: a popping sound or sensation in an erect penis, sudden loss of the ability to maintain an erection, bruising, swelling, or pain in your penis, trouble urinating or blood in your urine.
  • Tell your doctor right away if you have sudden lower back pain moving to your legs, feet, arms, or chest, or difficulty in walking after receiving this medicine.
  • You may take over-the-counter (OTC) pain medicines if you have mild to moderate pain in your penis.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have itching, rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause bleeding or bruising at the injection site. Tell your doctor if you have blood clotting problems before receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Take Xiaflex?

Before receiving Xiaflex injections, talk with your healthcare provider if the following applies to you:

  • Severe allergic reaction: If you have a severe allergic reaction to Xiaflex or any of its components (ingredients), then Xiaflex isn't an ideal treatment option for you.
  • Pregnant parents: Animal studies suggest that Xiaflex is unlikely to have negative effects on an unborn fetus, but use Xiaflex with caution. Talk with your healthcare provider to weigh the benefits and risks of using Xiaflex during your pregnancy.
  • Nursing parents: It's unknown if Xiaflex is present in breastmilk. With many medications being present in breastmilk, however, use Xiaflex with caution while nursing. If you have questions or concerns about using Xiaflex while nursing, speak with your healthcare provider.
  • Children: There is no safety or effectiveness information about Xiaflex in children less than 18 years of age.
  • Older adults: There are no safety and effectiveness differences for Xiaflex between older adults—people over 65 years of age—and younger adults.
  • People with a bleeding condition: People with a bleeding condition—like von Willebrand disease—might have a higher risk of injection-site bleeding, hematoma (bad bruising), and ecchymosis (discolored skin from bruising). Therefore, Xiaflex's prescribing information recommends against using Xiaflex in people with a bleeding condition.

What Other Medications Interact With Xiaflex?

If you've taken a blood thinner—like Coumadin (warfarin)—within the last seven days, avoid using Xiaflex. Combining a blood thinner with Xiaflex might raise the risk of the following side effects:

  • Discolored skin due to bruising
  • Hematoma
  • Injection-site bleeding

For more detailed information about medication interactions with Xiaflex, talk with your healthcare provider.

What Medications Are Similar?

Both Xiaflex and Qwo contain collagenases that come from Clostridium histolyticum bacteria.

While both medications are very similar, the FDA approved each for different uses. Xiaflex is approved for Dupuytren's contracture and Peyronie's disease. Qwo, on the other hand, is approved to treat cellulite (fat deposits under the skin) of the buttocks (butts) in adults assigned female at birth.

Currently, there are no other injectable collagenases available—especially for the treatment of Dupuytren's contracture and Peyronie's disease. While there's no worldwide agreement for the treatment of Dupuytren's contracture, collagenase is the standard in the United States. Experts also provide a moderate recommendation for collagenase in the treatment of Peyronie's disease.

Frequently Asked Questions

  • Where is Xiaflex available?

    You can only receive Xiaflex as an injection during an office visit with your healthcare provider.

  • How much does Xiaflex cost?

    Xiaflex is a biologic medication. It also doesn't have any available biosimilars, which could be slightly more affordable options. As a result, Xiaflex is typically expensive. If cost is a concern, Xiaflex's manufacturer does offer a copay assistance program for people with commercial or no insurance. For eligibility questions, visit the Endo Pharmaceuticals website for Dupuytren's contracture or call 1-877-942-3539. You can also visit the website for Peyronie's disease or call 1-800-743-2382.

  • How fast does Xiaflex work?

    How fast Xiaflex works will vary per person. Try to keep up with your follow-up appointments. Your healthcare provider will assess whether multiple treatment sessions are necessary.

How Can I Stay Healthy While Taking Xiaflex?

Consider the following general tips to stay healthy with Xiaflex:

  • Keep up with your appointments to not delay treatment of your condition.
  • Limit finger movements for one to three days after receiving a Xiaflex injection for Dupuytren's contraction.
  • Perform at-home finger exercises in between some appointments according to your healthcare provider's recommendations.
  • Perform at-home penile modeling activities in between some appointments according to your healthcare provider's recommendations.
  • Don't have sex for at least four weeks from the second injection of your treatment cycle for Peyronie's disease. Also, before having sex, make sure that you're no longer bruising or swelling.
  • Notify your healthcare provider of any concerning side effects.
  • Inform your healthcare provider of any changes to your medications or pregnancy status.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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