Collagenase clostridium histolyticum

XIAFLEX

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Pronunciation: kol-a-jen-ays-klos-trid-ee-um-his-toe-LIT-ik-um

Collagenase clostridium histolyticum ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Collagenase clostridium histolyticum ballicule

Collagenase clostridium histolyticum XIAFLEX mascot mnemonic cartoon — Visual mnemonic: Collagenase clostridium histolyticum mascot

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 ↗

BOXED WARNING Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease; available only through the Xiaflex REMS Program.

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

Available strengths

inj 0.9 mg/vial

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.

Cost

Collagenase clostridium histolyticum (XIAFLEX)

Strength		#/mo	generic $/unit	CostPlus
0.9 mg/vial	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Collagenase clostridium histolyticum is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNING

Corporal rupture in Peyronie disease

Classes and tags

Antineoplastic drugs

Clinical profile

Therapeutic safety burden3 / 4

Sedation liability0 / 4

Direct muscarinic antagonism0 / 4

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