Xiaflex (collagenase Clostridium histolyticum)

Collagenase Enzymes, Injectable Injection Vial (EA)

Advertisement

Last reviewed · Source: First Databank (FDB) drug data

Overview

Collagenase clostridium histolyticum is an enzymatic agent containing a mixture of 2 proteinases derived from Clostridium histolyticum that hydrolyze collagen.

Collagenase clostridium histolyticum is an enzymatic agent isolated and purified from the fermentation of Clostridium histolyticum. Collagenase clostridium histolyticum is a mixture of 2 microbial collagenases, collagenase AUX-I (clostridial type I collagenase) and collagenase AUX-II (clostridial type II collagenase), in a fixed ratio. These collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiologic conditions resulting in lysis of collagen deposits.

Injection of collagenase clostridium histolyticum may result in enzymatic disruption of Dupuytren's cord, which is comprised mostly of collagen. Collagenase clostridium histolyticum injection may also result in enzymatic disruption of the predominant collagen found in Peyronie's plaques (comprised mostly of collagen). In vitro data suggest that the collagenases AUX-I and AUX-II work synergistically to hydrolyze collagen.

There are no clinical data available regarding the relative contribution of collagenase AUX-I or AUX-II to the overall efficacy of collagenase clostridium histolyticum for Dupuytren's contracture or for Peyronie's disease.

Collagenase clostridium histolyticum is not absorbed systemically to any significant degree. Following administration of a single 0.58-mg dose into the collagen cord of patients with Dupuytren's contracture, there were no detectable plasma concentrations of collagenase clostridium histolyticum for up to 30 days. In patients with Peyronie's disease, low levels of collagenase clostridium histolyticum were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration into the penile plaque.

USES: This medication is used to treat certain conditions (Dupuytren's contracture, Peyronie's disease) that are caused by a certain protein (collagen) in your body. Collagen is a tough and strong substance and is found in the knots/cords of the hand in Dupuytren's contracture or plaques in the penis in Peyronie's disease. Collagenase is a substance (enzyme) that breaks down the collagen in these knots/cords/plaques.

Generic name: collagenase Clostridium histolyticum
Pronunciation: (KOL-a-JEN-ase klos-TRID-ee-um HIS-toe-LIT-ik-um)
Drug class: Collagenase Enzymes, Injectable
Therapeutic class: Locomotor System

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

Today’s intelligence on Xiaflex

Intelligence content is not available yet.

Indications

The following indications are listed for Xiaflex:

  • Dupuytren's Contracture
  • Peyronie's Disease

Also known as: Contracture Of Palmar Fascia, Dupuytren's Fibromatosis, Fibrous Cavernitis, Hand Dupuytren's Contracture, Induratio Penis Plastica, Palmar Fascial Fibromatosis, Penile Fibromatosis, Penis Plastica, Van Buren's Disease.

Dosing

No dosing information is available for this tab.

Drug interactions

There is no enhanced messaging for this drug.

Contraindications

*Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure.

*Patients with a history of hypersensitivity to collagenase clostridium histolyticum or to collagenase used in any other therapeutic application or application method.

Adverse reactions

The most common adverse reactions reported in >=25% of patients treated with collagenase clostridium histolyticum for Dupuytren's contracture were peripheral edema (e.g., swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity.

The most common adverse reactions reported in >=25% of patients treated with collagenase clostridium histolyticum for Peyronie's disease were penile hematoma, penile swelling, and penile pain.

Precautions

No enhanced messaging available.

ICD codes

CodeTypeDescription
Dupuytren's contracture
M72.0ICD10CMPalmar fascial fibromatosis [dupuytren]
Peyronie's disease
N48.6ICD10CMInduration penis plastica

ICD code information from First Databank (FDB).

Formulary status

Search health-plan coverage for this drug by ZIP code.

Enter a ZIP code to view available health plans.

Last reviewed · Source: First Databank (FDB) drug data