Xiaflex

Generic name:

Collagenase clostridium histolyticum

Drug class:

Enzymatic therapy (collagenase)

Dosage form:

Lyophilized powder for reconstitution; single-use vials

Root of administration:

Intralesional injection

Dose:

Dupuytren contracture: 0.58 mg per injection per cord; up to 3 injections per 30-day cycle; maximum 3 cycles.

Peyronie’s disease: 0.58 mg per injection; two injections per cycle 1–3 days apart; up to 4 cycles with at least 6 weeks between cycles.

Varies by indication; consult label.

Mechanism of action:

Specific collagenases (AUX-I and AUX-II) hydrolyze type I and III collagen, cleaving the fibrous cords in Dupuytren contracture or plaques in Peyronie’s disease, thereby reducing contracture and curvature.

Drug usage cases:

• Dupuytren contracture with palpable cord(s) causing finger contracture
• Peyronie’s disease with stable penile curvature and palpable plaque
• Off-label: Ledderhose disease (plantar fibromatosis)
• Off-label: Frozen shoulder (adhesive capsulitis)
• Off-label: Other superficial fibrotic disorders

Drug contra indications:

• Hypersensitivity to collagenase or any excipient
• Infection at the injection site (e.g., cellulitis)
• Open wounds or ulcers in the treatment area
• Known bleeding diathesis or concurrent anticoagulant therapy
• Neuromuscular disorders affecting the hand or penis
• Peyronie’s disease with calcified plaques

Side effects:

• Injection site hemorrhage
• Swelling, pain, bruising, edema
• Injection site reactions (redness, tenderness, pruritus)
• Lymphadenopathy
• Muscle spasms (Dupuytren contracture)
• Painful erection, penile swelling, hematoma (Peyronie’s disease)
• Allergic reactions, including anaphylaxis
• Tendon or ligament rupture
• Neuropraxia or nerve injury
• Rash, urticaria

Warnings:

• Anaphylaxis and serious allergic reactions; ensure emergency medications and equipment are available
• Tendon rupture or ligament injury; assess risk and counsel patients to limit use of the treated area after injection
• Injection site hemorrhage and hematoma; apply firm pressure post-injection
• Peyronie’s disease: risk of penile fracture; advise sexual abstinence until healing
• Avoid injecting near neurovascular structures to prevent nerve injury
• Monitor for hypersensitivity; discontinue if severe reaction occurs
• Use aseptic technique to minimize infection risk

Use during pregnancy or breastfeeding:

Pregnancy: Animal studies have not demonstrated adverse fetal effects, but no adequate human studies exist. Use only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding: It is unknown whether collagenase is excreted in human milk. Consider discontinuing breastfeeding or the drug, taking into account the importance of treatment to the mother.