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Treatment for adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

XIAFLEX® is the only FDA-approved nonsurgical treatment option for appropriate patients with Peyronie's disease and is also recommended 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

Xiaflex Patient Video from AuxiliumMarketing on Vimeo.

Mechanism of action

See how XIAFLEX® works.

Please see the full Prescribing Information, including Boxed Warning and Medication Guide.

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®.

Clinicians may administer intralesional collagenase clostridium histolyticum in combination with modeling by the clinician and by the patient for the reduction of penile curvature in patients with stable Peyronie's disease, penile curvature >30° and <90°, and intact erectile function (with or without the use of medications). (Moderate Recommendation; Evidence Strength Grade B)2

Clinicians should counsel patients with Peyronie's disease prior to beginning treatment with intralesional collagenase regarding potential occurrence of adverse events, including penile ecchymosis, swelling, pain, and corporal rupture. (Clinical Principle)2

  • 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®

STORAGE

Before Reconstitution1

Vial of XIAFLEX, temperature gauge, and vial of supplied diluent

Store in refrigerator (36°F to 46°F; 2°C to 8°C).

Do not freeze. Ensure both vials are upright prior to refrigerating.

After Reconstitution1

Temperature gauges and vial of XIAFLEX solution

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

How to prepare XIAFLEX® for injection1

Dose Preparation1

Use a new hubless syringe 0.01-mL graduations with a permanently fixed 27-gauge 0.5″ needle

Withdraw 0.25 mL of reconstituted solution (0.58 mg of XIAFLEX®) using the hubless syringe.

If solution contains particulates, is cloudy or discolored, do not use. The entire reconstituted XIAFLEX® solution contains 0.9 mg of XIAFLEX® and is for single use. Discard unused portion.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
Penis stretching when the penis is not erect, 3x per day
  • 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
Penis straightening when the penis is erect, 1x per day
  • 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

Important Safety Information for XIAFLEX®

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 combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation was reported, and in these cases, 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.

Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Because of the risks of corporal rupture or other serious penile injury, XIAFLEX® is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX® REMS Program.

  • XIAFLEX® is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX® or to collagenase used in any other therapeutic application or application method
  • Injection of XIAFLEX® into collagen‑containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX® should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen‑containing structures of the penis
  • In the double‑blind, placebo‑controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX®‑treated patients (4%) compared to placebo‑treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX® injection procedures). The incidence of XIAFLEX®‑associated pruritus was similar after each injection regardless of the number of injections administered
  • Because XIAFLEX® contains foreign proteins, severe allergic reactions to XIAFLEX® can occur. Anaphylaxis was reported in a post‑marketing clinical trial in one patient who had previous exposure to XIAFLEX® for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX® injections. The safety of more than one treatment course of XIAFLEX® is not known
  • In the XIAFLEX® controlled trials in Peyronie's disease, 65.5% of XIAFLEX®‑treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low‑dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX® in patients receiving anticoagulant medications (other than low‑dose aspirin, e.g., up to 150 mg per day) within 7 days prior to XIAFLEX® administration is not known. In addition, it is recommended to avoid use of XIAFLEX® in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low‑dose aspirin)
  • In the XIAFLEX® clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain

INDICATION

XIAFLEX® is indicated for 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.

Please see the full Prescribing Information, including Boxed Warning and Medication Guide.

References:

1.  XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.
2.  Nehra A, Alterowitz R, Culkin DJ, et al. Peyronie’s disease: AUA guideline. J Urol. 2015;194(3):745-753.