Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing
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.
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).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.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.īecause 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. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients. 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. WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE'S DISEASEĬorporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies.
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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. 3 It is estimated that PD can affect as many as 1 in 10 men in the U.S., 4 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help. This curvature can be painful during arousal and intimacy. Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis.
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Even among men who were initially considered non-responders after the first two cycles of injections, results suggested incremental benefits with performing a full series of four CCH cycles. 1,2ĭata support that incremental reductions in penile curvature were obtained from each of the four CCH treatment cycles administered to men with PD. For all patients, treatment included penile plaque modeling. 1 CCH injections were administered in up to four treatment cycles at 6-week intervals each cycle included two injections 1-3 days apart. 1,2Ĭhanges from baseline and from the previous penile curvature measurement were calculated after each of the four treatment cycles (weeks 6, 12, 18 and 24). The analysis included men who received at least one and up to four injections of study medication. and Landon Trost, M.D.Ī post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled Phase 3 trials was conducted to evaluate incremental changes in penile curvature over the course of CCH treatment in men with PD. "Incremental Treatment Response by Cycle With Collagenase Clostridium Histolyticum for Peyronie's Disease: A Pooled Analysis of Two Phase 3 Trials" was submitted by authors Matthew Ziegelmann, M.D. "The data analysis points to the importance of patient adherence to treatment protocol for efficacy and positive therapeutic outcomes when treating PD with XIAFLEX ®," said Dr.
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