Collagenase clostridium histolyticum
XIAFLEX
What it isBacterial collagenase injected into the lesion; Dupuytren contracture and Peyronie disease.
Why this oneIt dissolves the cord without surgery, allowing office treatment.
What limits itCorporal rupture in Peyronie disease, and tendon rupture in Dupuytren. Injection must be precisely placed.
FDA-approved for
- Dupuytren contracture with a palpable cord (2010)
- Peyronie disease (2010)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Dupuytren's contracture with a palpable cord | Adults | 0.58 mg injected into the palpable cord (MP or PIP joint contracture) | Repeat up to 3 times per cord at ~4-week intervals | 0.58 mg per injection; up to 2 cords/joints per hand per visit |
| Peyronie's disease (palpable plaque, curvature deformity >=30 degrees) | Adult men | 0.58 mg into target plaque, 2 injections 1–3 days apart per treatment cycle | Up to 4 treatment cycles at ~6-week intervals | 0.58 mg per injection |
Renal Undefined
Hepatic Undefined
Dupuytren's: up to 3 injections per cord at ~4-week intervals; Peyronie's: up to 4 cycles at ~6-week intervals
Instructions
- Administered by a healthcare provider experienced in the relevant procedures; reconstitute with the supplied diluent only
- Dupuytren's: perform a finger extension procedure ~24–72 h after injection if contracture persists
- Peyronie's: perform a penile modeling procedure 1–3 days after the second injection of each cycle
- Stop Peyronie's cycles if curvature <15 degrees or further treatment not indicated
Contraindications
- Peyronie's plaques that involve the penile urethra
Cautions
- Tendon rupture/serious injury to injected finger/hand (Dupuytren's)
- Corporal rupture/serious penile injury (Peyronie's)
- Hypersensitivity reactions including anaphylaxis
- Use with caution in patients with abnormal coagulation or on anticoagulants (other than low-dose aspirin)
- Acute post-injection back pain
- Syncope and presyncope
Adverse reactions
- Dupuytren's: peripheral edema (hand swelling), contusion, injection site hemorrhage/reaction, pain in injected extremity
- Peyronie's: penile hematoma, penile bruising, penile pain
Pregnancy Pregnancy Category B; no adequate human studies; use only if clearly needed; systemic exposure is minimal after local injection.
Lactation It is not known whether collagenase clostridium histolyticum is excreted in human milk; exercise caution in nursing women.
⚠ BOXED WARNING
- Corporal rupture in Peyronie disease
Classes and tags
Clinical profile
Mechanism of action: Collagenase clostridium histolyticum ballicule
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