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Collagenase clostridium histolyticum (Injection)

Generic name: collagenase clostridium histolyticum [ kol-AJ-e-nase-klos-TRID-ee-um-his-toe-LIT-ik-um ]
Brand name: Xiaflex
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Last updated on Jul 20, 2023.

Injection route(Powder for Solution)

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%) collagenase clostridium histolyticum-treated patients in clinical studies. In other collagenase clostridium histolyticum-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or penile "popping" sound or sensation was reported, 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%) collagenase clostridium histolyticum-treated patients.

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.

Because of the risks of corporal rupture or other serious penile injury, collagenase clostridium histolyticum is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the collagenase clostridium histolyticum REMS program .

Uses for collagenase clostridium histolyticum

Collagenase clostridium histolyticum injection is used to treat Dupuytren's contracture with a palpable cord. It is also used to treat Peyronie's disease with a palpable plaque and curvature deformity in men.

This medicine is to be given only by or under the supervision of your doctor.

Before using collagenase clostridium histolyticum

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of collagenase clostridium histolyticum injection in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of collagenase clostridium histolyticum injection in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of collagenase clostridium histolyticum

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into the cord that is causing your finger to bend or into the plaque that is causing your penis to curve.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are receiving this medicine for Dupuytren's contracture:

If you are receiving this medicine for Peyronie's disease:

Precautions while using collagenase clostridium histolyticum

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you are receiving this medicine for Dupuytren's contracture:

If you are receiving this medicine for Peyronie's disease:

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have itching, rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause bleeding or bruising at the injection site. Tell your doctor if you have blood clotting problems before receiving this medicine.

Fainting or near fainting may occur after you receive this medicine. Check with your doctor right away if you feel dizzy or faint. You may lie down until your symptoms go away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of collagenase clostridium histolyticum

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common—Dupuytren's contracture

More common—Peyronie's disease

Less common—Peyronie's disease

Incidence not known—Dupuytren's contracture

Incidence not known—Peyronie's disease

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—Dupuytren's contracture

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Tissue Permeability Modifier

Pharmacologic Class: Collagenase

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.