Collagenase Clostridium Histolyticum

What it is and how it works

A mixture of two collagenases (AUX-I and AUX-II) produced by Clostridium histolyticum. Injected directly into a collagen cord or plaque, it hydrolyses interstitial collagen types I and III, causing enzymatic disruption of the cord or plaque.

Indications

Dupuytren’s contracture in adults with a palpable cord; in some markets also Peyronie’s disease with a palpable plaque and curvature deformity.

Dosage and administration (summary)

Dupuytren’s contracture: 0.58 mg injected into a palpable cord by a physician experienced in the procedure, followed by a finger extension procedure about 24–72 hours later; injections may be repeated at approximately 4-week intervals, up to 3 injections per cord.

Contraindications

Hypersensitivity to collagenase or to any excipient; in Peyronie’s disease, involvement of the penile urethra.

Warnings and precautions

Tendon or ligament rupture and other serious injury of the injected extremity can occur; the product must be injected only into the cord. Penile fracture (corporal rupture) has been reported in Peyronie’s disease. Use with caution in patients with coagulation disorders or taking anticoagulants; severe allergic reactions may occur.

Pregnancy

Data are limited; avoid in pregnancy unless clearly necessary.

Storage and supply

Store refrigerated at 2–8 °C; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.