Preparation<sup>1,10</sup>

Each Xiapex box contains one single-use vial of Xiapex powder and one single-use vial of diluent for reconstitution (contains 0.3 mg/ml calcium chloride dihydrate). Two hubless syringes with 0.01 ml graduation and a permanently fixed needle (26/27 gauge) are required (one for reconstitution and one for administration).

Preparation volumes
Sterile diluent required for reconstitution Injection vol. to deliver Xiapex 0.58 mg dose
MP JOINT 0.39 ml MP JOINT 0.25 ml
PIP JOINT 0.31 ml PIP JOINT 0.20 ml


Procedure1,10

Day 1 - Xiapex injection procedure
Inject reconstituted Xiapex (0.58 mg/injection) into palpable Dupuytren’s cord. Wrap treated hand in soft, bulky gauze dressing. Instruct patient not to attempt to disrupt the cord themselves. Up to two cords or two affected joints in the same hand can be treated according to the injection procedure during a treatment visit. Two palpable cords affecting two joints or one palpable cord affecting two joints in the same finger may be injected at two locations. When administering two injections in the same hand during a treatment visit, begin with the affected finger in the most ulnar aspect of the hand and continue toward the radial aspect (eg, fifth finger to index finger). Within each finger, begin with the affected joint in the most proximal aspect of the finger and continue toward the distal aspect (eg, MP to PIP).

Each injection contains a 0.58 mg dose. If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.

24-72 hours - Finger extension procedure
Perform finger extension procedure approximately 24-72 hours hours post-injection in order to facilitate cord rupture (local anaesthesia use permitted). No more than three attempts to disrupt the cord should be performed. Fit the patients with a splint after the procedure. If cords of two affected joints in one finger were treated, perform the finger extension procedure on the cord affecting the MP joint before performing the procedure on the cord affecting the PIP joint.

30 days later - Follow-up visit
If greater response is required, cord injection and finger extension procedure can be repeated up to three times per cord at ≈ 30 day intervals. 

Storage1

Refrigeration

The single-dose vial of Xiapex and the single-dose vial containing solvent for injection for reconstitution should be kept refrigerated between 2°C and 8°C.

Before reconstitution, both vials should be removed from the refrigerator and allowed to stand at room temperature (20 to 25°C), for at least 15 minutes, but no longer than 60 minutes.

IMPORTANT

Xiapex must be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and management of Dupuytren’s disease.

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Dupuytren’s disease

Peyronie’s disease