Introduction
Xiaflex (collagenase clostridium histolyticum) is a biologic medication approved by the FDA for the treatment of adult patients with Dupuytren's contracture with a palpable cord and Peyronie's disease. It represents a minimally invasive alternative to surgical intervention for these connective tissue disorders.
Mechanism of Action
Xiaflex contains purified bacterial collagenases that work by enzymatically lysing collagen deposits in affected tissues. The medication specifically targets types I and III collagen, which are the primary collagen types found in Dupuytren's cords and Peyronie's disease plaques. This enzymatic degradation leads to the breakdown of excessive collagen accumulation, allowing for improved mobility and function.
Indications
- Dupuytren's contracture: Treatment of adult patients with Dupuytren's contracture with a palpable cord
- Peyronie's disease: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees
Dosage and Administration
For Dupuytren's contracture:- 0.58 mg per injection into the palpable cord
- Up to 3 injections per cord per treatment session (0.25 mL each)
- Repeat injections may be administered approximately 4 weeks apart
- 0.58 mg per injection into the Peyronie's plaque
- Maximum of 2 injections per treatment session (0.25 mL each)
- Treatment cycles may be repeated every 6 weeks
- Must be administered by healthcare professionals trained in injection technique
- Reconstitute with supplied diluent
- Administer within 60 minutes of reconstitution
- Use proper aseptic technique
- Renal impairment: No dosage adjustment required
- Hepatic impairment: No dosage adjustment required
- Elderly: No dosage adjustment required
Pharmacokinetics
- Absorption: Local injection with minimal systemic absorption
- Distribution: Primarily localized to injection site
- Metabolism: Degraded by proteolytic enzymes
- Elimination: Systemic components eliminated via renal pathway
- Half-life: Approximately 1-2 hours for systemic components
Contraindications
- Hypersensitivity to collagenase clostridium histolyticum or any excipients
- Administration to areas other than the cord (Dupuytren's) or plaque (Peyronie's)
- Use in children and adolescents
Warnings and Precautions
- Tendon ruptures: Serious tendon injuries may occur
- Ligament damage: Potential for ligament injury
- Nerve injury: Peripheral nerve injury possible
- Corporal rupture: Serious penile injury in Peyronie's treatment
- Hypersensitivity reactions: Including anaphylaxis
- Ecchymosis/bleeding: Increased risk in patients on anticoagulants
- Penile hematoma: Common in Peyronie's treatment
Drug Interactions
- Anticoagulants: Increased risk of bleeding (careful risk-benefit assessment required)
- Antiplatelet agents: Potential increased bleeding risk
- No formal drug interaction studies conducted
Adverse Effects
Common adverse reactions:- Edema
- Contusion
- Injection site hemorrhage
- Pain
- Tenderness
- Lymphadenopathy
- Pruritus
- Skin laceration
- Tendon rupture or ligament damage
- Nerve injury
- Corporal rupture (Peyronie's)
- Severe allergic reactions
- Skin tear
Monitoring Parameters
- Pre-treatment: Physical examination of affected area
- During treatment: Monitor for injection site reactions
- Post-injection: Evaluate for adverse effects including tendon/ligament integrity
- Follow-up: Assess range of motion (Dupuytren's) or curvature (Peyronie's)
- Allergic reactions: Monitor for signs of hypersensitivity
Patient Education
- Expect local swelling, bruising, pain, or tenderness at injection site
- Report any severe pain, numbness, tingling, or weakness immediately
- Avoid manipulating or stretching the treated area until advised by healthcare provider
- Understand proper aftercare instructions
- Recognize signs of allergic reaction (rash, itching, swelling, dizziness)
- Follow-up appointments are essential for optimal outcomes
- Discuss all medications with healthcare provider before treatment
References
1. FDA prescribing information: Xiaflex (collagenase clostridium histolyticum) 2. Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009;361(10):968-979. 3. Gelbard M, Goldstein I, Hellstrom WJ, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of Peyronie's disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013;190(1):199-207. 4. Warwick D, Arner M, Pajardi G, et al. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015;40(2):124-132. 5. American Urological Association Guidelines on Peyronie's Disease (2015) 6. American Society for Surgery of the Hand guidelines on Dupuytren's disease