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

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Patient Savings

Patients can save with the Copay Assistance Program

With the XIAFLEX Copay Assistance Program

Eligible patients may save on their out-of-pocket costs for each vial of XIAFLEX. Each treatment cycle consists of 2 XIAFLEX injection procedures, requiring 2 vials of XIAFLEX, and patients may save on both vials.1

~94% of eligible patients should pay $0

out of pocket with the XIAFLEX Copay Assistance Program2*

Restrictions for patients apply. See Restrictions, Terms, and Conditions below.†

*Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023.

Patient eligibility

Patients qualify for assistance under this program if:

  • They are receiving or have received XIAFLEX for an approved indication and in a manner consistent with the instructions for administration of XIAFLEX
  • They are uninsured or have insurance that is not provided by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, Veterans Affairs (VA), Medicaid, or similar federal or state programs, and this program is not otherwise prohibited by law
  • They are 18 years of age or older
  • They have paid or are obligated to pay out-of-pocket costs for a prescription of XIAFLEX

No other purchase is necessary to receive this offer.
For more information, call 1-800-743-2382.

  1. By accepting this offer, you agree to report the value received under this offer to any health insurer or other third party paying for any part of the XIAFLEX prescription if you are required to do so by benefit terms, contract, or law.
  2. This offer is not valid for prescriptions reimbursed in whole or in part by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, VA, Medicaid, or similar federal or state programs, or where otherwise prohibited by law.
  3. By accepting this offer, you agree that Endo USA, Inc. or those working on its behalf may contact your doctor to verify information about treatment that is relevant to verifying your eligibility for this offer.
  4. This offer is only valid for doses of XIAFLEX administered in the US.
  5. This offer is valid for the out-of-pocket cost for the dose of XIAFLEX only. Offer is not valid for any other products or other out-of-pocket costs (for example, office visit charges, office visit copays, or injection/administration costs), even if those costs are associated with the administration of a dose of XIAFLEX.
  6. This offer is valid only if you have not used this program within the last 30 days.
  7. The selling, purchasing, trading, or counterfeiting of this offer is prohibited.
  8. Endo USA, Inc. reserves the right to rescind, revoke, or amend this offer without notice.
  9. By participating, you understand and agree to comply with the terms and conditions of this offer as set forth above.
Efficacy of XIAFLEX
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Important Safety Information

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 ReactionsClinical 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

References: 1. XIAFLEX® [package insert]. Rochester, MI: Endo USA, Inc. 2. Data on file. DOF-XPD-31. Endo USA, Inc.; December 6, 2023.