What Is Collagenase Clostridium Histolyticum?

Collagenase clostridium histolyticum is a purified enzyme derived from the bacterium Clostridium histolyticum. This prescription medication addresses medical conditions characterized by excessive collagen accumulation, a structural protein found throughout the body. It targets these abnormal collagen deposits to help restore normal function and appearance.

How Collagenase Works

Collagen is the most abundant protein in the human body, providing structural support and elasticity to tissues like skin, tendons, and ligaments. Its structure consists of three polypeptide chains wound together to form a strong triple helix. Collagenase clostridium histolyticum functions by specifically targeting and breaking down these dense, abnormal collagen fibers.

The medication contains two distinct collagenase enzymes, AUX-I and AUX-II. AUX-I primarily attacks the C- and N-termini of the collagen molecule, while AUX-II cleaves amino acid bonds within the molecule’s core. This targeted enzymatic process, known as hydrolysis, breaks the peptide bonds within collagen’s triple-helical structure. The enzyme acts like tiny, precise scissors, cutting through tightly wound threads of collagen that form unwanted cords or plaques.

Medical Applications

Collagenase clostridium histolyticum treats specific conditions where abnormal collagen buildup leads to functional impairment or aesthetic concerns.

Dupuytren’s Contracture

In Dupuytren’s contracture, a cord of collagen-rich tissue forms beneath the skin in the palm of the hand, causing fingers to bend inward and become difficult to straighten. The injection of collagenase clostridium histolyticum directly into this palpable cord dissolves it. This enzymatic breakdown disrupts the cord, allowing for the restoration of finger extension and improved hand function. The U.S. Food and Drug Administration (FDA) approved this treatment for Dupuytren’s contracture in 2010.

Peyronie’s Disease

Peyronie’s disease involves the formation of a fibrous collagen plaque on the penis, which can lead to curvature, indentation, and pain during erection. The injection targets this collagen plaque, breaking down the hardened tissue. By dissolving the plaque, the treatment reduces penile curvature and discomfort, improving erectile function and quality of life. The FDA approved this use for men with palpable plaques and a curvature deformity of at least 30 degrees in 2013.

Cellulite

Collagenase clostridium histolyticum-aaes, marketed as Qwo, is also used to treat moderate to severe cellulite in the buttocks of adult women. Cellulite often results from fibrous septae, which are collagen bands that tether the skin to underlying tissues, creating dimples and an uneven skin surface. When injected into areas of cellulite, the enzyme disrupts these fibrous septae, releasing the tension that pulls the skin down. This diminishes the dimpling effect and improves skin appearance. This formulation received FDA approval in July 2020.

The Treatment Process

Collagenase clostridium histolyticum is administered through direct injection into the affected tissue, whether it is a collagen cord in the hand, a plaque in the penis, or the fibrous septae contributing to cellulite. These procedures are performed in a doctor’s office.

For Dupuytren’s contracture, the medication is injected into the palpable cord, often at multiple sites along its length. Following the injection, the treated hand is wrapped in a soft dressing, and patients limit motion and keep the hand elevated until bedtime. A few days after the injection, the physician performs a manual manipulation to break apart the weakened collagen cord and straighten the finger.

In the case of Peyronie’s disease, the medication is injected directly into the collagen plaque causing the curvature. A full treatment cycle involves two injections administered one to three days apart. One to three days after the second injection, the physician performs a penile modeling procedure, gently stretching and straightening the penis to reduce the deformity. Patients are also instructed on how to perform gentle stretching and straightening exercises at home for several weeks following the procedure.

Potential Side Effects and Risks

As with any medical treatment, collagenase clostridium histolyticum can cause side effects, ranging from common and localized reactions to rare but serious risks. Patients experience localized reactions at the injection site. These common effects include swelling, bruising, pain, tenderness, and itching, which are mild to moderate and resolve within two to three weeks.

For individuals receiving treatment for Peyronie’s disease, a rare but serious risk is corporal rupture, also known as penile fracture, which involves damage to the internal structures of the penis. This has been reported in approximately 0.5% of patients in clinical studies, with other serious penile injuries like severe hematoma occurring in about 3.7% of patients. Signs of such injury can include a popping sound or sensation during an erection, sudden loss of erection, significant pain, extensive bruising or swelling of the penis, or difficulty with urination. Due to these risks, the treatment for Peyronie’s disease is available only through a restricted program that includes a Risk Evaluation and Mitigation Strategy (REMS).

Allergic reactions, including severe systemic reactions like anaphylaxis, are another potential risk, as the medication contains foreign proteins. Symptoms of a serious allergic reaction can include itching, rash, hives, chest pain, dizziness, lightheadedness, trouble breathing, or swelling of the hands, face, or mouth. Other less common but serious side effects reported include fainting or near fainting, particularly if associated with severe penile pain, and localized skin and soft tissue necrosis, which may occur as a complication of penile hematoma.

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