XIAFLEX in Los Gatos and Mountain View, CA

Understand the Risks

Risks of Corporal Rupture and Penile Injury in Peyronie's Treatment

When being treated with Xiaflex Mountain View patients are typically covered by Medicare and most PPO health insurance plans. Dr Karpman’s office will check your insurance benefits prior to scheduling your injections so that you are aware of any out of pocket costs for the procedure. Patients who receive Xiaflex are not allowed to have sex or masturbate for 2 weeks after the final injection. Penile fracture has occurred in clinical studies in men who had sex within 2 weeks of their final injection. The actual incidence of this occurrence is very low and listed below. Below are pictures of a patient before and after Xiaflex treatment.

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.