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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

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 more than 11,000 adult men who were queried about a diagnosis of Peyronie's disease in the US, a history of seeking care for the disease, or having related symptoms.1

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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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.  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.