XIAFLEX® is the only FDA-approved nonsurgical treatment option for appropriate patients with Peyronie's disease and is also included in the AUA Guideline. Learn about mechanism of action, the AUA Guideline, treatment overview, and post-procedure care.
XIAFLEX® helps disrupt Peyronie's plaque collagen1
- In vitro studies suggest that XIAFLEX® disrupts 2 predominant types of collagen found in Peyronie's plaque1
- Following this enzymatic disruption of the plaque, penile curvature deformity and patient Bother caused by Peyronie's disease are reduced1
Mechanism of action
See how XIAFLEX® works.
AUA Peyronie's disease treatment guideline for XIAFLEX®
In 2015, the AUA published a guideline that provides a clinical framework for the diagnosis and treatment of Peyronie's disease. The following guideline statements are specific to XIAFLEX®.
- Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate2
- Body of Evidence Strength Grade B in support of a Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence2
A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature.2
Storage and preparation of XIAFLEX®
Store in refrigerator (36°F to 46°F; 2°C to 8°C).
Do not freeze. Ensure both vials are upright prior to refrigerating.
Keep, if necessary, at room temperature (68°F to 77°F; 20°C to 25°C) for up to 1 hour or refrigerate (36°F to 46°F; 2°C to 8°C) for up to 4 hours.
If refrigerated, let stand at room temperature for approximately 15 minutes before use.1
XIAFLEX® can be administered in office1
Please see the full Prescribing Information to learn about Dosing and Administration information for XIAFLEX®.
- During both the first and second office visits, XIAFLEX® 0.58 mg is injected into the Peyronie's plaque collagen 1 to 3 days apart1
- After the injection appointments (1 to 3 days after the second injection of the cycle), the healthcare professional (HCP) modeling is performed to stretch and elongate the plaque1
- This procedure helps relieve penile curvature deformity and straighten the penile shaft
Up to 4 treatment cycles may be administered1*
- Patients should be instructed to self-perform penile modeling activities at home each day for the 6-week period following the HCP penile modeling procedure of each treatment cycle1
* If the curvature deformity is less than 15° after the first, second, or third treatment cycle, or if the HCP determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.1
A treatment course of XIAFLEX® with up to 4 treatment cycles takes approximately 24 weeks to complete1
Each treatment cycle consists of 2 XIAFLEX® injection procedures and penile modeling1
If the curvature deformity is <15° after the first, second, or third treatment cycle, or if the HCP determines that further treatment is not clinically indicated, then subsequent treatment cycles should not be administered1
Penile modeling: Your patients' important role in treatment
In addition to the in-office penile modeling procedure, patients should be instructed to self-perform penile modeling activities at home each day for the 6-week period following the investigator penile plaque modeling visit of each treatment cycle as follows1:
- During spontaneous erections, gently attempt to straighten the penis without producing pain and hold the penis in a straightened position for 30 seconds
- The flaccid penis should be gently stretched 3 times daily. Slow, gentle force should be used without producing pain
- Patient should grasp the tip of the penis with the fingers of one hand and hold the base of the penis with the fingers of the other hand (see diagram)
- The penis is gently pulled away from the body to its full length
- The stretch is held for 30 seconds
- The patient should then let go to allow the penis to return to its normal, unstretched length
- This stretching activity should be performed 3 times each day, only when the penis is not erect
- If the patient has a spontaneous erection not related to sexual activity, an attempt should be made to straighten the penis by gently bending the shaft in the opposite direction of the curve, but not so forcefully so as to produce significant pain or discomfort
- The penis should then be held in this more straightened position for 30 seconds, then let go
- This straightening activity should be performed only 1 time each day. If your patient does not have a spontaneous erection, he should not attempt the penis straightening activity