Collagenase clostridium histolyticum

XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX is a combination of bacterial collagenases indicated for the treatment of: Adult patients with Dupuytren’s contracture with a palpable cord. Adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Injection of XIAFLEX into a Dupuytren’s cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord. The signs and symptoms of Peyronie’s disease are caused by a collagen plaque. Injection of XIAFLEX into a Peyronie’s plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie’s disease are reduced. Results of in vitro studies, including those of explant tissues containing Peyronie’s plaques, suggest that XIAFLEX disrupts the predominant collagen found in plaques (Types I and III).

Dupuytren’s Contracture. XIAFLEX should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren’s contracture. Reconstitute XIAFLEX lyophilized powder with only the supplied diluent prior to use. Inject 0.58 mg of XIAFLEX into each palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint according to the injection procedure. Up to two joints in the same hand may be treated during a treatment visit. Approximately 24 to 72 hours following an injection, perform a finger extension procedure if a contracture persists. Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals. Inject up to two cords in the same hand at a treatment visit.

XIAFLEX is contraindicated in: the treatment of Peyronie’s plaques that involve the penile urethra due to potential risk to this structure. patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method. Peyronie’s plaques that involve the penile urethra. History of hypersensitivity to XIAFLEX or to collagenase used in other therapeutic applications

Boxed warning: Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044, 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Tendon rupture or serious injury to the injected finger/hand: Avoid injecting XIAFLEX into tendons, nerves, blood vessels, or other collagen-containing structure of the hand. Injection into these structures may result in possible permanent injury, such as tendon rupture, ligament damage, or skin laceration.

The following serious adverse reactions are discussed in greater detail elsewhere in the labeling: Tendon ruptures or other serious injury to the injected extremity Corporal rupture (penile fracture) and severe penile hematoma Hypersensitivity Reactions, Including Anaphylaxis Risk of Bleeding in Patients with Abnormal Coagulation Acute Post-Injection Back Pain Reactions Syncope and Presyncope The most common adverse reactions (≥25%) are: Dupuytren’s Contracture: edema peripheral (e.g., swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, pain in the injected extremity. Peyronie’s Disease: penile hematoma, penile swelling and penile pain

Anticoagulant drugs: XIAFLEX should be used with caution in patients receiving concomitant anticoagulants (except for low-dose aspirin).

Do not freeze. and Stability Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration.