What causes Peyronie’s disease?

  • Peyronie's disease is a localized connective tissue disorder that affects the tunica albuginea of the penis1-3
  • It is thought to occur after injury or repetitive microtrauma1-3
  • Abnormal scar tissue develops into a plaque under the skin of the penis, causing erectile curvature1-3
Watch the Mechanism for Peyronie’s Disease

Why many may go undiagnosed

Because of the embarrassment involved with Peyronie's disease, men may not seek help, leaving the condition undiagnosed.6

*Based on a survey of about 7,700 U.S. adult men with a PD diagnosis, PD-related symptoms, or a history of seeking treatment for the condition.2

Hear from actual patients

92% of men with Peyronie's disease did not receive that diagnosis the first time they saw an HCP for penile symptoms1

Percentage of men who visited an HCP for penile symptoms1
8 percent received a diagnosis
49 percent received no treatment
25 percent were advised to 'wait and see'
48 percent were diagnosed with erectile dysfunction

HCP=healthcare professional.

Peyronie's disease is a distinct disease that requires a separate diagnosis and treatment. Because it is not likely to go away on its own and may even get worse, you can help your patients by screening for it.7

Screening considerations for Peyronie's disease

Ask your patients about erectile curvature, because they may not ask you6

Clinicians should engage in a diagnostic process to document the signs and symptoms that characterize Peyronie's disease. The minimum requirements for this examination are a careful history and a physical exam of the genitalia (to assess for palpable abnormalities of the penis).8

Other conditions may be present in patients with Peyronie's disease

Depression (9), erectile dysfunction (10), hypogonadism (11), and type 2 diabetes mellitus (12)

Peyronie's disease is a distinct condition. Treatment of Peyronie's disease does not cover or imply treatment of these conditions.

When screening, take into consideration your patient's Bother as well

What is the Bother domain score?

  • Clinical trials for XIAFLEX® evaluated the Bother domain score, which is a composite of the following patient-reported items: concern about erection pain, erection appearance, and impact of Peyronie's disease on intercourse and on frequency of intercourse13,14

Why is it important?

  • Patients with erectile curvature as low as 30 degrees may have similar Bother to patients with higher degrees of curvature14

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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.


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.

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.


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.

  • Contraindications: 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
  • Corporal Rupture or Other Serious Injury to the Penis: 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. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
  • Hypersensitivity Reactions, Including Anaphylaxis: 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
  • Risk of Bleeding in Patients with Abnormal Coagulation: 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)
  • Acute Post-Injection Back Pain Reactions: Post-marketing reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity
  • Syncope and Presyncope: Most, but not all cases of syncope and presyncope in patients with Peyronie’s disease, occurred in association with post-injection penile pain and hematoma, penile pain with spontaneous erections, and pain during micturition. These potential triggers suggest a vasovagal mechanism. Make patients aware of the potential symptoms that could trigger syncope and presyncope after treatment with XIAFLEX.
    If presyncopal symptoms occur, patients should remain recumbent until symptoms resolve. Syncope may be associated with bodily injuries, including concussion, head abrasion, and other accidental injuries

Adverse Reactions

Clinical trials

  • 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.

Post-marketing experience

  • Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments
  • Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention
  • Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie’s disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported

Click for full Prescribing Information, including BOXED WARNING and Medication Guide.

References:

1.  DiBenedetti DB, Nguyen D, Zografos L, Ziemiecki R, Zhou X. A population-based study of Peyronie’s disease: prevalence and treatment patterns in the United States. Adv Urol. 2011:282503. doi:10.1155/2011/282503.
2.  Stuntz M, Perlaky A, des Vignes F, Kyriakides T, Glass D. The prevalence of Peyronie’s disease in the United States: a population-based study. PLoS One. 2016;11(2):e0150157.
3.  National Institutes of Health of the US Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Peyronie’s Disease. NIH Publication No. 14-3902. June 2014.
4.  Ralph D, Gonzalez-Cadavid N, Mirone V, et al. The management of Peyronie’s disease: evidence-based 2010 guidelines. J Sex Med. 2010;7(7):2359-2374.
5.  Jalkut M, Gonzalez-Cadavid N, Rajfer J. Peyronie’s disease: a review. Rev Urol. 2003;5(3):142-148.
6.  Hellstrom WJ. History, epidemiology, and clinical presentation of Peyronie’s disease. Int J Impot Res. 2003;15(Suppl 5):S91-S92.
7.  Bella AJ, Perelman MA, Brant WO, Lue TF. Peyronie’s disease. J Sex Med. 2007;4(6):1527-1538.
8.  Nehra A, Alterowitz R, Culkin DJ, et al. Peyronie’s disease: AUA guideline. J Urol. 2015;194(3):745-753.
9.  Nelson CJ, DiBlasio C, Kendirci M, Hellstrom W, Guhring P, Mulhall JP. The chronology of depression and distress in men with Peyronie’s disease. J Sex Med. 2008;5(8):1985-1990.
10.  El-Sakka Al. Prevalence of Peyronie’s disease among patients with erectile dysfunction. Eur Urol. 2006;49(3):564-569.
11.  Cavallini G, Biagiotti G, Lo Guidice C. Association between Peyronie disease and low serum testosterone levels: detection and therapeutic considerations. J Androl. 2012;33(3):381-388.
12.  Kendirci M, Trost L, Sikka SC, Hellstrom WJ. Diabetes mellitus is associated with severe Peyronie’s disease. BJU Int. 2007;99(2):383-386.
13.  Data on file. DOF-XPD-02. Endo Pharmaceuticals Inc; September 21, 2015.
14.  Hellstrom WJ, Feldman R, Rosen RC, Smith T, Kaufman G, Tursi J. Bother and distress associated with Peyronie’s disease: validation of the Peyronie’s disease questionnaire. J Urol. 2013;190(2):627-634.