Last reviewed 2026-04-20 · How we verify

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE 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. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients [see Warnings and Precautions (5.2)] . Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention [see Warnings and Precautions (5.2)] . Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie’s disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program [see Warnings and Precautions (5.3)] . WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE See full prescribing information for complete 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 diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients. ( 5.2 ) XIAFLEX is available for the treatment of Peyronie’s disease only through a restricted program called the XIAFLEX REMS Program. ( 5.3 )

Common side effects

• Edema peripheral (swelling of injected hand)
• Contusion
• Injection site hemorrhage
• Injection site reaction
• Pain in injected extremity
• Penile hematoma
• Penile swelling
• Penile pain
• Pruritus
• Vasovagal syncope

Serious adverse events

• Flexor tendon rupture

Key clinical trials

• Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease (PHASE4)
• Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease (NA)
• A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) (PHASE2)
• Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease (PHASE4)
• Trial Comparing Treatment Strategies in Dupuytren's Contracture (PHASE4)
• Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks (PHASE2)
• Effectiveness of Splinting After Collagenase Injection (PHASE3)
• Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease (PHASE4)

Primary sources

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