Introduction
Xiaflex (collagenase clostridium histolyticum) is a treatment approved for certain connective tissue disorders. These conditions involve abnormal buildup of collagen, leading to thickened or hardened tissue that can interfere with normal movement or function. In Peyronie’s disease, for example, collagen forms plaques within the penis, often linked to factors like trauma, family history, or related conditions such as Dupuytren’s contracture.1
Traditional approaches to these disorders have included oral or topical medicines, injections, traction, shockwave therapy, and even surgery. But many of these options have shown limited effectiveness, with surgery often being the only definitive solution. Xiaflex offers a new approach: when injected directly into the affected area, it works by breaking down excess collagen and influencing the biological processes that cause plaque formation. Clinical studies have shown that Xiaflex can safely reduce plaque hardness and curvature, while also improving patient satisfaction. 1
Background
Collagenase clostridium histolyticum (CCH) was first isolated in 1953. Decades later, in 1996, it was introduced as a new therapeutic option for conditions such as Dupuytren’s contracture. Researchers have identified a total of seven different collagenases, which are grouped into two main classes based on their protein structure, the type of collagen they act on, and their gene of origin. These two classes form the foundation of how CCH was developed as a treatment, since they specifically target the types of collagen (I and III) that are central to plaque formation in certain diseases.1
Approved Uses
Collagenase clostridium histolyticum (CCH) has been studied as a treatment for conditions where excess collagen causes tissue to thicken and deform over time. One such condition is Dupuytren’s contracture, which affects the hand. CCH has been used as a treatment option for this condition.2
A related condition is Peyronie’s disease (PD), which occurs when abnormal collagen build-up forms plaques in the penis.
In December 2013, the U.S. Food and Drug Administration (FDA) approved CCH, marketed as Xiaflex®, making it the only pharmacologic treatment option for Peyronie’s disease. 2
In short, XIAFLEX is indicated for the treatment of:3
- Adult patients with Dupuytren’s contracture with a palpable cord
- Adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy
Mechanism of Action
CCH contains two classes of enzymes, called AUX-I and AUX-II, that work together to break down collagen. AUX-I targets the ends of the collagen’s triple-helix structure, while AUX-II works on the internal parts of the helix with a broader reach and stronger binding ability. By acting on type I and III collagen, CCH directly dismantles the abnormal plaques responsible for Peyronie’s disease.1
Beyond breaking down collagen fibers, CCH also affects the activity of cells involved in plaque development. It reduces the overproduction of certain genes, proteins, and growth factors that contribute to the hardening and thickening of tissue. It also limits cell attachment and growth within the plaque. Importantly, CCH does not significantly affect collagen type IV—which is a key building block around blood vessels and nerves—except under very high doses or prolonged exposure. This selectivity allows CCH to mainly target diseased tissue while sparing most healthy structures.1
Administration Overview
For Dupuytren’s contracture, XIAFLEX is given by a trained healthcare provider. The medicine is prepared right before use and injected directly into the tight cord in the hand that causes the finger to bend. In a single visit, one or two joints in the same hand may be treated. About one to three days after the injection, if the finger is still bent, the doctor may carefully stretch and straighten it in what is called a finger extension procedure. If needed, the process of injection and stretching can be repeated for the same cord, with about four weeks between sessions, up to a maximum of three times. If there are other cords that also need treatment, these can be addressed during later visits.3
For Peyronie’s disease, XIAFLEX is also given only by a healthcare provider, specifically one experienced in treating male urological conditions. The medicine is prepared and injected directly into the firm plaque in the penis that is responsible for the curvature. Treatment happens in cycles, and each cycle includes two injections given one to three days apart, followed by a modeling procedure, where the provider gently stretches or straightens the penis. Sometimes, a medication may be used to create an erection temporarily, which helps the provider locate the exact area to inject. Up to four treatment cycles may be given, usually spaced about six weeks apart. However, if the curve improves to less than fifteen degrees after a cycle, or if further treatment is not considered necessary, then additional cycles are not given. 3
Adverse Effects
In Dupuytren’s contracture, most patients had some local reaction in the treated hand or finger. These were usually mild or moderate and went away within about four weeks without treatment. Common problems included swelling, bruising, bleeding, pain, or skin irritation at the injection site. Only a very small number of patients experienced tendon rupture. 3
In Peyronie’s disease, most men also experienced local side effects in the treated area. These included bruising under the skin, swelling, or pain in the penis. Most of these problems were mild or moderate and cleared up within about two weeks. A small number of patients did experience more serious injury, including corporal rupture or severe bleeding, and some cases of severe hematoma were reported.
Most side effects settle on their own, but because some can be serious, it is important to stay alert after treatment and inform your doctor if you notice anything unusual.3
Precautions
XIAFLEX should not be used in certain cases. It is not given for Peyronie’s plaques that involve the urethra because of the possible risk to that area. It should also not be used in anyone who has had allergic reactions to XIAFLEX or to collagenase used in other treatments.
Allergic reactions can occur with XIAFLEX. Some patients reported mild itching, while rare cases of severe allergic reactions, including anaphylaxis, have also happened. Because of this, doctors need to be prepared to treat serious allergic responses if they occur. 3
There is also a risk of bleeding or bruising after injection. Many patients in clinical trials developed bruising or bleeding at the injection site. Because of this, XIAFLEX is not recommended for people with certain blood clotting problems or those taking anticoagulants (other than low-dose aspirin). 3
Some people treated for Peyronie’s disease reported sudden back pain right after injection, which could spread to the legs, arms, or chest. These episodes usually went away within minutes to half an hour, but sometimes lasted longer and required pain relief.
In both Dupuytren’s contracture and Peyronie’s disease, some patients fainted or felt faint (presyncope). This sometimes happened right after the injection or procedure, often linked with pain or bruising. Fainting can occasionally cause injuries like falls or head bumps. Patients are advised to lie down if they start feeling lightheaded until the feeling passes.3
Clinical Data
In Dupuytren’s contracture, two major studies tested XIAFLEX in adults with bent fingers. Patients could get up to three injections, followed by gentle finger stretching, splinting at night, and daily exercises. More people treated with XIAFLEX were able to straighten their finger close to normal compared to those who got placebo. After just one injection, 39% and 27% of patients in the two studies reached near-normal straightening, versus only 1% and 5% with placebo. A long-term follow-up (up to five years) showed that some successfully treated joints did see the contracture return. 3
In Peyronie’s disease, two trials tested XIAFLEX in men with a penile curvature of at least 30 degrees. Treatment included up to four cycles of injections, each followed by a modeling procedure done by the doctor and more modeling at home. By one year, XIAFLEX significantly improved curvature compared to placebo. The degree of improvement was similar whether the starting bend was moderate (30–60 degrees) or more severe (61–90 degrees).3
Conclusion
XIAFLEX (collagenase clostridium histolyticum) is an approved treatment option for adults with Dupuytren’s contracture and for men with Peyronie’s disease. Clinical studies have shown that it can meaningfully improve finger contractures and penile curvature compared to placebo. While most side effects are mild to moderate and resolve on their own, some can be more serious, which is why treatment is always performed by trained healthcare professionals. For patients and caregivers, XIAFLEX represents a non-surgical approach that can help manage conditions where excess collagen leads to contracture or curvature.
Note:
This information is provided for educational purposes only and is not a substitute for medical advice. Patients should always consult their doctor or qualified healthcare provider to discuss whether XIAFLEX is appropriate for their condition, and to understand the possible risks and benefits of treatment.
Disclaimer:
Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import.
References
- Peak TC, Mitchell GC, Yafi FA, Hellstrom WJ. Role of collagenase clostridium histolyticum in Peyronie's disease. Biologics. 2015;9:107-116. Published 2015 Sep 29. doi:10.2147/BTT.S65619
- Ahn ST, Moon DG. Collagenase clostridium hystolyticum in the management of Peyronie's disease. Transl Androl Urol. 2017;6(2):305-307. doi:10.21037/tau.2017.01.15
- XIAFLEX PRESCRIBING INFORMATION
