Xiaflex
Xiaflex is a collagen-specific enzyme that's used as a non-surgical treatment for adults with conditions called Peyronie's disease and Dupuytren’s contracture. It works by breaking down thickened tissue in certain parts of the body. This medication is injected into specific areas of thickened tissue with the help of a trained healthcare provider at a clinic. Side effects can include swelling and pain at the injected area. There's also a risk for serious ligament or tendon damage.
What is Xiaflex (collagenase)?
What is Xiaflex (collagenase) used for?
Dupuytren’s contracture in certain adults
Peyronie’s disease in certain men
How Xiaflex (collagenase) works
Xiaflex (collagenase) is an enzyme (protein) that breaks down collagen.
For Dupuytren’s contracture, it breaks up hard tissue caused by stored up collagen in the hand. This helps straighten bent fingers.
For Peyronie's disease, it breaks up (or plaque) under the skin of the penis that causes it to curve.
Drug Facts
What are the side effects of Xiaflex (collagenase)?
Common Side Effects
- Bruising in the penis (up to 66%)
- Swelling of the penis (55%)
- Pain in the penis (45%)
- Swelling (usually of the injected hand; 73%)
- Bruising (70%)
- Bleeding at the injection site (38%)
- Injection site reaction (e.g., redness, irritation, warmth; 35%)
- Pain in the injected hand (35%)
- Tenderness (24%)
- Swelling at the injection site (24%)
Other Side Effects
- Blood blister
- Penis blister
- Itchy genitals
- Pain during injection procedure
- Painful erection
- Pain during sex
- Erectile dysfunction
- Skin color changes
- Itchiness
- Skin cut
- Skin redness
- Swollen or painful lymph nodes
- Armpit pain
Serious Side Effects
- Complications from treatment for Peyronie's disease: severe pain, swelling, or bruising on penis; blood in urine; sharp back pain
- Complications from treatment for Dupuytren's contracture: changes in sensation of touch in your finger(s); trouble bending your finger(s); deep skin cuts
- Serious allergic reaction: hives; chest pain; trouble breathing; swelling of your lips, tongue, or face; dizziness; fainting; anaphylaxis
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common—Dupuytren's contracture
Bruising or bleeding at the injection site
swelling of the hands
tearing of the skin
More common—Peyronie's disease
Itching, pain, redness, swelling, or bruise of the penis
popping sound or sensation in an erect penis
Less common—Peyronie's disease
Decreased interest in sexual intercourse
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
painful sexual intercourse
Incidence not known—Peyronie's disease
Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or tightness
difficult or labored breathing
lower back pain, possibly radiating to the legs, feet, arms, or chest
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common—Dupuytren's contracture
Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, lumps, numbness, rash, scarring, stinging, tingling, or ulceration at the injection site
bruise
flushing, redness of the skin or unusually warm skin at the injection site
itching, pain, swelling, or tenderness at the injection site
swollen, painful, or tender lymph glands in the neck or armpit
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Xiaflex (collagenase)
Pros
Directly injected into the area that's causing the problem
Can get multiple injections over time depending on your response to treatment
Cons
Must be injected by a trained healthcare provider
Commonly causes discomfort at the injection site
Unknown if safe or works well for children under 18 years old
Pharmacist tips for Xiaflex (collagenase)
For Peyronie's disease:
After your Xiaflex (collagenase) injection, it's normal to see some bruising and swelling on your penis. But call your provider right away if you have severe pain, swelling, or bruising on your penis; blood in your urine; or trouble urinating.
Your provider will teach you exercises to do at home to help stretch and straighten your penis. Do these exercises every day for 6 weeks after each treatment.
To help with healing, don't have sex between the first and second injections of a Xiaflex (collagenase) treatment cycle and for at least 4 weeks after the second injection of a treatment cycle. Ask your provider when you can have sex again after each treatment cycle.
Avoid using a vacuum erection device during treatment with Xiaflex (collagenase).
Make sure to avoid situations that could cause you to strain your stomach muscles, like straining to have a bowel movement, while you're getting treated with Xiaflex (collagenase).
For Dupuytren’s contracture:
Don't flex or extend your fingers after your Xiaflex (collagenase) injection(s) until your provider gives you further instructions. This lessens the risk of having medication leak out of the cord(s). Also, don't mess with the injected cord after your treatment.
Keep your injected hand elevated (raised) until you go to bed on the day of your injection(s).
Be sure to go to your follow-up appointment about 1 to 3 days after your Xiaflex (collagenase) injection(s). Your provider will gently stretch the affected finger to help straighten it.
Follow your provider's instructions to do finger exercises every day for a few months to help stretch your fingers. Your provider will also give you a finger splint to protect your finger and keep it straight while you sleep; use the splint for a few months after treatment.
Frequently asked questions about Xiaflex (collagenase)
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What are the risks and warnings for Xiaflex (collagenase)?
Xiaflex (collagenase) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious injury to the penis (for Peyronie's disease only)
Xiaflex (collagenase) should only be injected by a trained healthcare provider. When treating Peyronie's disease, providers are trained to avoid injecting into the urethra (a structure needed for urination), nerves, blood vessels, erectile tissue inside the penis, or other collagen-containing structures of the penis. Injection into these areas can cause severe injury, such as a penile fracture. In some serious situations, surgery might be necessary.
Because of the serious risk for penile injury, Xiaflex (collagenase) is only available through a restricted Risk and Evaluation Mitigation Strategy (REMS) program called the Xiaflex REMS program. This program helps make sure that only trained providers inject this medication, people are made aware of its risks, and only certified healthcare settings provide it.
Tendon rupture or serious injury to the injected finger or hand (for Dupuytren's contracture only)
Xiaflex (collagenase) should only be injected by a trained healthcare provider. When treating Dupuytren’s contracture, providers are trained to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. Injection into these areas can cause permanent or severe injury, such as tendon rupture, ligament damage, or deep skin cuts. In some serious situations, surgery might be necessary.
Allergic reactions
Risk factors: More injections of Xiaflex (collagenase) than recommended
Some people who got more injections of Xiaflex (collagenase) than recommended had mild allergic reactions, such as itching. In addition, it's possible to have severe allergic reactions to Xiaflex (collagenase). This can include anaphylaxis (e.g., closing of the throat). Tell your provider or get medical help right away if you feel itchy, dizzy, or faint or if you have hives, chest pain, trouble breathing, or swelling of your lips, tongue, or face.
Bleeding risk
Risk factors: Medical history of blood clotting problems | Taking blood thinners
In clinical studies of people with Dupuytren’s contracture, Xiaflex (collagenase) commonly caused bruising or bleeding at the injection site on the hand. In clinical studies of people with Peyronie's disease, Xiaflex (collagenase) also often caused bruising at the injection site on the penis.
Bleeding can be especially dangerous if you have a history of a clotting problem or if you're taking blood thinners because these factors can raise your risk of bleeding even more. Make sure to tell your provider about your full medical history and all the medications you're taking before you start Xiaflex (collagenase) treatments.
Sudden back pain after injections
Risk factors: Treating Peyronie's disease
Some people with Peyronie's disease reported having sudden back pain immediately or within minutes after Xiaflex (collagenase) injections. The feeling can either be mild or quite severe and can spread to the legs, arms, and chest. Usually, this pain only happens after you've gotten a few injections already; it typically doesn't happen after the first injection. This pain usually goes away after about half an hour, and you usually don't need any additional medications to help treat the pain. Let your provider know if you have any back pain after your injection(s).
Lightheadedness and fainting
Some people who were treated with Xiaflex (collagenase) felt lightheaded or have fainted. For people with Peyronie's disease, most cases were related to having pain in the penis or pain while urinating after injections. For people with Dupuytren's contracture, most cases were related to the treatment procedure or pain from the injections; these symptoms typically happened right after or within 1 to 2 days after the procedure. Lie down if you feel lightheaded or faint until these symptoms go away so you don't hurt yourself.
Xiaflex (collagenase) dosage forms
Typical dosing for Xiaflex (collagenase)
This medication is given as an injection directly into the scar tissue by a trained healthcare provider. Your provider will determine how many treatments of Xiaflex (collagenase) you need based on how you respond to the medication.
Dupuytren’s contracture: Your provider will inject 0.58 mg directly into the cord of tissue in your hand. You can get an injection in up to two joints in your hand during a treatment visit. You can have up to 3 treatment visits that are each one month apart.
Peyronie's disease: Your provider will inject 0.58 mg directly into a bump in your penis (Peyronie's plaque). This is followed by a second injection 1 to 3 days later. Your provider will inject Xiaflex (collagenase) into the plaque that's causing the penis to bend. You might need up to 4 treatment cycles that are each six weeks apart.
Interactions between Xiaflex (collagenase) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Xiaflex (collagenase) contraindications
Peyronie’s plaques that involve the penile urethra (tube that lets urine out of the body)
Allergy to other collagenase products
Xiaflex (collagenase) images
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References
Best studies we foundAlipour, H., et al. (2016). Therapeutic applications of collagenase (metalloproteases): A review. Asian Pacific Journal of Tropical Biomedicine.
American Society for Surgery of the Hand. (2021). Dupytren’s contracture.
Endo Pharmaceuticals Inc. (2022). Xiaflex- collagenase clostridium histolyticum kit [package insert]. DailyMed.
Gelbard, M., et al. (2013). Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. The Journal of Urology.
Hurst, L. C., et al. (2009). Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. The New England Journal of Medicine.
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