Xiapex is supplied in single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution. Sterile diluent for reconstitution is supplied in the package in a single-use glass vial containing 3 ml of 0.3 mg/ml calcium chloride dihydrate in 0.9% sodium chloride. Xiapex must be reconstituted with the provided diluent prior to use.
Xiapex treatment - improvement possible in 7 weeks1
A treatment course consists of a maximum of 4 treatment cycles. Each treatment cycle consists of 2 Xiapex injection procedures and one in-office penile modeling procedure. The second Xiapex injection procedure occurs 1 to 3 days after the first injection. The in-office penile modeling procedure is performed 1 to 3 days after the second injection of the treatment cycle (see picture above). It is necessary to identify the treatment area prior to each treatment cycle.
After the third office visit of each treatment cycle, the patient performs approximately 6 weeks of daily, at home penile modeling activities.
Up to 4 treatment cycles (for a total of 8 injection procedures and 4 modeling procedures) may be administered per plaque causing the curvature deformity. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the healthcare provider determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.2
- Reconstitution with supplied diluent
- Induction of erection, localization of the plaque
- Injection of Xiapex
- Penile modeling procedure
Prior to reconstitution, the vials of lyophilized powder of Xiapex and sterile diluent should be stored in a refrigerator at 2°C to 8°C. Do not freeze.
Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and check the labels on both the diluent vial and the lyophilized powder vial to make sure they have not expired. Allow the 2 vials to stand at room temperature for at least 15 minutes but no longer than 60 minutes.
- Xiapex Summary of Product Characteristics.
- Gelbard et al. J Urology 2013;190:199-207.