Jesse N. Mills, MD, presented “Off-Label Use of Xiaflex for Peyronie’s Disease” during the 41st Annual Ralph E. Hopkins Urology Seminar on February 3, 2022, in Jackson Hole, Wyoming.
How to cite: Mills, Jesse N. “Off-Label Use of Xiaflex for Peyronie’s Disease” February 3, 2022. Accessed Jul 2024. https://grandroundsinurology.com/off-label-use-of-xiaflex-for-peyronies-disease/
Off-Label Use of Xiaflex for Peyronie’s Disease
Jesse N. Mills, MD, Associate Clinical Professor and Director of the Men’s Clinic at UCLA, discusses the off-label use of Xiaflex (collagenase clostridium histolyticum) to treat Peyronie’s disease. These include alternative injection techniques, plaques involving the penile urethra, use for men on anticoagulation treatments, and non-goniometric deformity. Dr. Mills discusses Xiaflex’s label requirements and why he does not use it on-label, explaining that, according to the label, it is strictly for adult males over 18 with a curvature greater than 30 degrees at the start of the therapy. Additionally, the physician is directed to install the treatment while withdrawing within the needle tract. Dr. Mills asserts it does not need to be acute to fit within the label’s requirements. Next, he describes the off-label treatment using the “FAN” method, which is like a microdose, distributing the material over a greater surface area. He states that this method provides a better distribution of material, a lower complication rate of hematoma at about 5% (versus 58% from the IMPRESS trial), and is an easier technique for the physician to perform. Next, Dr. Mills describes the hematoma classification system and how to use it to guide Peyronie’s patient treatment. He explains the definitions of the acute stage, which can be either if there is a plaque less than a year old or if the plaque is still changing or evolving, and that studies show similar outcomes in patients during the acute phase. Dr. Mills continues by stating that patients on anticoagulation stronger than baby aspirin had the same rate of hematoma according to a 2020 study. He says they are likely safe to inject Xiaflex into patients on anticoagulation therapy, although this is considered off-label. Next, he discusses that the label states that physicians cannot treat a plaque involving the urethra, but there are not a lot of options to treat those patients. He explains that atypical deformities such as ventral deformities have equal outcomes to dorsal or lateral curvature, and ventral deformity had a greater improvement. He states that it is difficult to measure success with atypical deformities, but physicians could offer Xiaflex to these patients.
About The 41st Annual Ralph E. Hopkins Urology Seminar:
The Ralph E. Hopkins Urology Seminar is a multi-day meeting focused on training urologists in the latest in assessing, diagnosing, and treating urologic conditions in the clinical setting. Updates are provided on urologic cancers, stone disease, urologic reconstruction, female urology, infertility, emerging surgical techniques, and general urology. Dr. Stoffel presented this lecture during the 41st iteration of the meeting on February 3rd, 2022 in Jackson Hole, Wyoming.
For further educational activities from this conference, visit our collection page.
ABOUT THE AUTHOR
Dr. Jesse N. Mills, MD, is a clinical professor of urology at the David Geffen School of Medicine at the University of California Los Angeles (UCLA). He is division chief of andrology, director of the Men’s Clinic at UCLA, fellowship director of the UCLA male reproductive medicine and surgery program, and director of UCLA Urology Santa Monica.
Dr. Mills is internationally recognized as a thought leader in male fertility, hypogonadism, erectile dysfunction, Peyronie's disease, and microsurgery. He has performed thousands of penile implants, vasectomy reversals, varicocelectomy and complex Peyronie's disease surgeries, and Xiaflex injections over the course of his career.
Dr. Mills completed his medical degree at the University of Iowa Hospitals and Clinics in 2001, followed by his residency at the University of Colorado Health Science Center in 2007. He then completed his fellowship at Baylor College of Medicine in 2008 and received his medical board certification in urology from the American Board of Urology in 2010. His clinical specialties revolve around men's health and include male hormone management, sexual and ejaculatory dysfunction, male fertility, and Peyronie's disease. He is also the author of the bestselling book A Field Guide to Men's Health.
