Postmarketing Experience of Intralesional Collagenase Clostridium histolyticum (Xiaflex®) Injection in Men with Peyronie’s Disease

Autor: Madison Berezansky, Edward D. Kim, Jonathan W. Angelle, Ryan C. Owen
Rok vydání: 2017
Předmět:
Zdroj: Current Sexual Health Reports. 9:74-78
ISSN: 1548-3592
1548-3584
DOI: 10.1007/s11930-017-0105-6
Popis: There are limited data on postmarketing patient outcomes, as well as safety and management of complications, with use of intralesional collagenase Clostridium histolyticum (Xiaflex®). This review aims to highlight recent postmarketing experiences and management concepts of intralesional collagenase C. histolyticum (Xiaflex®) use. Postmarketing data may help determine whether the frequency of collagenase C. histolyticum-related corporal ruptures is similar to real-world clinical experience compared to phase III clinical trials. Additionally, corporal ruptures have been observed outside the recommended abstinence period outlined by the Risk Evaluation and Mitigation Strategy protocol. These findings, coupled with compromised tissue quality observed at time of surgical repair, have led to controversies in the management of collagenase C. histolyticum-related corporal ruptures. Corporal ruptures remain a concern as reported in the Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Study trials. With evidence of advanced local tissue degradation leading to delayed corporal ruptures, an evolving management of these injuries is developing. Close observation, rather than surgical intervention, may be an appropriate treatment option for selected patients. Lengthening the recommended abstinence period from the time of the last injection may be prudent with the administration of intralesional collagenase C. histolyticum. Postmarketing efficacy data have been consistent with phase III trials.
Databáze: OpenAIRE
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