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How does XIAFLEX® work?

XIAFLEX® helps disrupt 2 collagen types within a Peyronie's plaque1

  • At higher doses and longer incubation times, nonfibrillar type IV collagen was affected causing collagen lysis in small veins1
  • Did not cause structural damage to arteries, nerves, or large veins that contain type IV collagen in in vitro or in vivo studies1
  • There are no clinical data regarding the relative contributions of the individual collagenases to the efficacy of XIAFLEX® in the treatment of Peyronie’s disease1

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.1

AUA Peyronie's disease treatment guideline for XIAFLEX®

In 2015, the American Urological Association (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

What does treatment with XIAFLEX® consist of?

A treatment course of XIAFLEX® takes ~24 weeks and consists of up to 4 treatment cycles approximately 6 weeks apart1

HCP=healthcare professional.

If the curvature deformity is less than 15 degrees after the first, second, or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered.1

The safety of more than one treatment course of XIAFLEX® is not known.1

Each treatment cycle involves1:

  • 3 office visits over the course of 3–7 days
  • Each cycle begins with the injection of XIAFLEX® into the palpable Peyronie's plaque
  • The second injection is performed 1–3 days later
    • Based on patient's penile swelling, you can assess if he is ready for the second injection
  • In-office modeling is performed 1–3 days after the second injection
  • The patient then performs at-home modeling for approximately 6 weeks

See the XIAFLEX® treatment procedure

Penile modeling: Helps reduce erectile curvature and straighten the penile shaft1

Offer patients a guide for treatment and at-home modeling

Storage & preparation of XIAFLEX®

Storage

Before Reconstitution1

Vial of XIAFLEX® and vial of the 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

Vial of XIAFLEX® solution

Can be kept 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 prior to administration.

If refrigerated, let stand at room temperature for approximately 15 minutes before use.

See how an experienced injector reconstitutes XIAFLEX®

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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, eg, 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.
3.  Data on file. DOF-XPD-03. Endo Pharmaceuticals Inc; January 7, 2016.
4.  Data on file. DOF-XPD-04. Endo Pharmaceuticals Inc; January 7, 2016.