REFER YOUR PATIENTS TO TRAINED INJECTORS
Trained injectors have:
- Experience in the treatment of male urological diseases
- Completed the Risk Evaluation and Mitigation Strategy
- Enrolled in the XIAFLEX® managed distribution program
When Peyronie's disease is on his mind
for your appropriate patients
In 2 large multicenter studies with XIAFLEX®, the co-primary endpoints were the percentage change from baseline to Week 52 in erectile curvature deformity and the change from baseline to Week 52 in the Bother domain score of the Peyronie's Disease Questionnaire (PDQ).1
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 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.
|1.||XIAFLEX® [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.|