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Understanding XIAFLEX® treatment procedure

Take an in-depth look at the treatment procedure for XIAFLEX® with one of the country's well-established injectors of XIAFLEX®, Dr. Martin Gelbard.

Dr. Gelbard is a urologist with more than 30 years of experience in the study of Peyronie's disease. He has also served as the principal investigator in several studies, and had been involved with the 2 pivotal clinical trials for XIAFLEX®.

This menu will become active after the presentation of the Boxed Warning. Please see Important Safety Information throughout this video.

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

Additional videos

Mechanism of disease: Watch the mechanism for Peyronie’s disease.


Learn about the pathologic wound healing that is characteristic of Peyronie's disease.

XIAFLEX® should be administered by a trained injector

XIAFLEX® should only be administered by a doctor experienced in the treatment of male urological diseases who has completed required Risk Evaluation and Mitigation Strategy (REMS) training for use of XIAFLEX® in the treatment of Peyronie's disease.1

Trained injectors of XIAFLEX® have satisfied the required components of the XIAFLEX® REMS Program, including1:

  • Certification with the program by enrollment and completion of training in the administration of XIAFLEX® treatment for Peyronie's disease
  • Providing a healthcare setting that is certified with the program to ensure that XIAFLEX® is only dispensed for use by trained injectors

To learn more about becoming a trained injector of XIAFLEX®, visit www.XIAFLEXREMS.com or call 1-877-313-1235.

XIAFLEX® REMS Program

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh the risks. Endo has worked with the FDA to develop the XIAFLEX® REMS Program.

Because of the risks of corporal rupture and other serious injuries to the penis in the treatment of Peyronie's disease, XIAFLEX® is available only through the XIAFLEX® REMS Program.

Download these forms to assist with patient education, access, and reimbursement for XIAFLEX®

For your patients: educational materials for download

Peyronie's Disease Discussion Guide

Help patients get the conversation started using the helpful questions in this discussion guide.

Patient Treatment Brochure

Educate patients starting out with XIAFLEX® on the 2 equally important parts of their treatment: working with a urologist and the important role patients play at home with penile modeling.

For healthcare professionals: helpful materials for download

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Specialty Sales Professional

Your Specialty Sales Professional (SSP) is your primary resource for information and process support related to XIAFLEX®

Check the information below that interests you. We will match you with a local XIAFLEX® representative who will contact you promptly.

Field Reimbursement Manager

Field Reimbursement Managers (FRM) are highly trained, field-based, Endo Pharmaceuticals reimbursement specialists

To address any case-specific coding, billing, and reimbursement questions, your SSP can refer you to a designated FRM.

Check the information below that interests you. We will match you with a local XIAFLEX® representative who will contact you promptly.

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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.

Reference:

1.  XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.