Xiaflex

Xiaflex^® (collagenase clostridium histolyticum) is an injectable treatment approved by the United States Food and Drug Administration (FDA) to treat conditions involving an excessive buildup of collagen, a structural protein in the body’s connective tissues. These conditions include Dupuytren’s contracture, where thickened tissue causes fingers to bend toward the palm, and Peyronie’s disease, in which scar tissue in the penis causes curved, painful erections.

Xiaflex works by breaking down collagen deposits via the enzyme collagenase, which helps restore mobility and reduce curvature in the affected areas of the body. 

In clinical trials, Xiaflex has been shown to effectively reduce penile curvature from Peyronie’s disease without the need for invasive surgery. However, the treatment may cause side effects when used for this condition, such as penile hematoma, penile swelling, and penile pain. Multiple injections may be required for optimal results. Proper administration by a trained healthcare provider is essential in order to minimize risks and maximize benefits.

Xiaflex (collagenase clostridium histolyticum) is indicated for:

• The treatment of adult patients with Dupuytren’s contracture with a palpable cord

• The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Combination of bacterial collagenases

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 (e.g., swelling of the injected hand)

• Bruising

• Injection site hemorrhage,

• Injection site reaction

• Pain in the injected extremity

Peyronie’s Disease

The most frequently reported adverse drug reactions reported with ≥25% of patients treated with Xiaflex and at an incidence greater than placebo were:

• Penile hematoma

• Penile swelling

• Penile pain

The cost of Xiaflex may vary depending on where you buy it and your insurance plan. The average retail price of Xiaflex is about $7,430 for one injection, but most health insurance plans cover Xiaflex, and the drug’s manufacturer offers a Copay Assistance Program that reduces the cost to as low as $0 for eligible people. People who do not have health insurance may be eligible to receive Xiaflex free of charge; ask your healthcare provider’s office for more information.

You can get a prescription for Xiaflex after being evaluated by your primary care provider or a specialist who can determine if the medicine is right for you based on factors like your symptoms and medical history.

• Peyronie’s plaques that involve the penile urethra

• History of hypersensitivity to Xiaflex or to collagenase used in other therapeutic applications

• Drug interactions: Anticoagulant drugs

• Tendon rupture or serious injury to the injected finger/hand

• Corporal rupture (penile fracture) or other serious injury to the penis

• Hypersensitivity reactions, including anaphylaxis

• Patients with abnormal coagulation: Use with caution

• Acute post-injection back pain reactions

• Fainting and lightheadedness

WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE

Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) Xiaflex-treated patients in clinical studies. In other Xiaflex-treated patients (9 of 1044; 0.9%), a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) Xiaflex-treated patients.

Xiaflex is available for the treatment of Peyronie’s disease only through a restricted program called the Xiaflex REMS Program.

There are other treatments for Peyronie’s disease and Dupuytren’s contracture. Some treatments may be better suited to you than others. If you’re interested in an alternative to Xiaflex, connect with a healthcare provider who can help you evaluate your options.

Treatment options for Peyronie’s disease include:

• Penile traction therapy, which uses a device designed to stretch the penis

• Other injectable medications, including interferon-α2b and verapamil (Verelan^®), prescribed off-label at the discretion of a healthcare provider 

• Oral medications and supplements, such as potassium para-aminobenzoate, vitamin E, or pentoxifylline (Pentoxil^®), prescribed off-label at the discretion of a healthcare provider

• Shockwave therapy

• Surgery

Treatment options for Dupuytren’s contracture include:

• Physical therapy

• Radiation

• Steroid injections

• Surgery

• Amputation

*This information is from the label for brand name Xiaflex^®. See the Full Prescribing Information for more complete information. Collagenase clostridium histolyticum, the active ingredient in Xiaflex, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient collagenase clostridium histolyticum.