How does XIAFLEX® work?
XIAFLEX® helps disrupt 2 collagen types within a Peyronie's plaque1
- At higher doses and longer incubation times, nonfibrillar type IV collagen was affected causing collagen lysis in small veins1
- Did not cause structural damage to arteries, nerves, or large veins that contain type IV collagen in in vitro or in vivo studies1
- There are no clinical data regarding the relative contributions of the individual collagenases to the efficacy of XIAFLEX® in the treatment of Peyronie’s disease1
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). 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.1
AUA Peyronie's disease treatment guideline for XIAFLEX®
In 2015, the American Urological Association (AUA) published a guideline that provides a clinical framework for the diagnosis and treatment of Peyronie's disease. The following guideline statements are specific to XIAFLEX®.
- Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate2
- Body of Evidence Strength Grade B in support of a Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence2
A Clinical Principle is a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature.2
What does treatment with XIAFLEX® consist of?
A treatment course of XIAFLEX® takes ~24 weeks and consists of up to 4 treatment cycles approximately 6 weeks apart1
If the curvature deformity is less than 15 degrees after the first, second, or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered.1
Each treatment cycle involves1:
See the XIAFLEX® treatment procedure
Penile modeling: Helps reduce erectile curvature and straighten the penile shaft1
Offer patients a guide for treatment and at-home modeling
Storage & preparation of XIAFLEX®
Store in refrigerator (36°F to 46°F; 2°C to 8°C).
Do not freeze. Ensure both vials are upright prior to refrigerating.
Can be kept at room temperature (68°F to 77°F; 20°C to 25°C) for up to 1 hour or refrigerate (36°F to 46°F; 2°C to 8°C) for up to 4 hours prior to administration.
If refrigerated, let stand at room temperature for approximately 15 minutes before use.