Xiaflex (collagenase Clostridium histolyticum)
Collagenase Enzymes, Injectable Injection Vial (EA)
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
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.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions 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.
There are no contraindication contraindications for this drug.
- Tendon rupture
There are no moderate contraindications for this drug.
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.
More Frequent
- Injection site sequelae
Rare or Very Rare
- Anaphylaxis
- Hematoma
- Lower back pain
- Rupture of corpus cavernosum of penis
- Tendon rupture
- Tissue necrosis
More Frequent
- Edema of penis
- Pain in extremities
- Pain in penis
- Penile hematoma
- Peripheral edema
Less Frequent
- Dyspareunia
- Ecchymosis
- Lacerations
- Lymphadenopathy
- Pruritus of skin
Rare or Very Rare
- Back pain
- Presyncope
- Syncope
Precautions
No enhanced messaging available.
Safety and efficacy of collagenase clostridium histolyticum have not been established in children younger than 18 years of age.
There are no adequate and well-controlled studies of collagenase clostridium histolyticum in pregnant women. Animal reproductive studies have not revealed any evidence of fetal harm. Collagenase clostridium histolyticum should be used during pregnancy only if clearly needed.
Almost all patients treated with collagenase clostridium histolyticum develop antibodies to the protein components of the drug (anti-AUX-I and anti-AUX-II); however, the clinical significance of such antibodies on a developing fetus is not known.
It is not known whether collagenase clostridium histolyticum is distributed into milk in humans. Caution is advised if the drug is administered in nursing women.
No overall differences in safety or effectiveness have been observed between geriatric patients 65 years of age and older and younger patients in clinical studies.
ICD codes
| Code | Type | Description |
|---|---|---|
| Dupuytren's contracture | ||
| M72.0 | ICD10CM | Palmar fascial fibromatosis [dupuytren] |
| Peyronie's disease | ||
| N48.6 | ICD10CM | Induration penis plastica |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.