Collagenase clostridium histolyticum Injection Advanced Patient Information - Drugs.com

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# Collagenase clostridium histolyticum (Injection)

Medically reviewed by Drugs.com. Last updated on Aug 6, 2022.

Injection route(Powder for Solution)

Warning: Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's diseaseCorporal 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 .

## Commonly used brand name(s)

In the U.S.

- Xiaflex

Available Dosage Forms:

- Powder for Solution

Therapeutic Class: Tissue Permeability Modifier

Pharmacologic Class: Collagenase

## 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.

Collagenase clostridium histolyticum 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 collagenase clostridium histolyticum, the following should be considered:

### Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to collagenase clostridium histolyticum 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.

### Pediatric

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.

### Geriatric

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 collagenase clostridium histolyticum. Make sure you tell your doctor if you have any other medical problems, especially:

- Blood clotting disorders—Use with caution. May make these conditions worse.

- Peyronie's plaque in the penile urethra—Should not be used in patients with this condition.

## Related/similar drugs

Xiaflex, collagenase clostridium histolyticum, Qwo

## Proper use of collagenase clostridium histolyticum

A nurse or other trained health professional will give you collagenase clostridium histolyticum in a hospital. Collagenase clostridium histolyticum 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.

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

If you are receiving collagenase clostridium histolyticum for Dupuytren's contracture:

- Your affected hand will be wrapped with a bandage after receiving the injection. Avoid moving and using your treated finger.
- Your doctor may give you 2 injections if you have more than one contracture in the same hand.
- It is very important that you return to your doctor 1 to 3 days after receiving the injection. This will allow your doctor to see the injected hand, and to do a possible finger extension procedure to disrupt the cord.
- It is very important that you elevate the fingers of the injected hand until bedtime to prevent swelling. Do not try to move or massage the cord, bend, or extend the fingers of the injected hand, or do heavy activity using your hand to prevent more injury.
- Your doctor may put a splint on your hand after giving collagenase clostridium histolyticum. Wear the splint at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your doctor.

If you are receiving collagenase clostridium histolyticum for Peyronie's disease:

- Collagenase clostridium histolyticum is available only through a restricted program called Xiaflex® REMS Program. Doctors who are enrolled in the restricted program can write a prescription for collagenase clostridium histolyticum.
- Your penis may be wrapped with a bandage after receiving the injection. Your doctor will tell you when to take the bandage off.
- Collagenase clostridium histolyticum is given as part of a treatment cycle. In a treatment cycle, you will receive an injection followed by a second injection 1 to 3 days later.
- It is very important that you return to your doctor 1 to 3 days after your second injection. This will allow your doctor to do a manual procedure to stretch and help straighten your penis.
- Do not have sexual intercourse or have any sexual activity between the first and second injections of a treatment cycle, and for at least 4 weeks after the second injection of a treatment cycle and after pain and swelling has gone away.
- Avoid situations that may cause straining your stomach muscles (eg, straining during bowel movements).

Detailed Collagenase clostridium histolyticum dosage information

## Precautions while using collagenase clostridium histolyticum

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

If you are receiving collagenase clostridium histolyticum for Dupuytren's contracture:

- Using collagenase clostridium histolyticum may cause injury to the blood vessels, tendons, or ligaments of the hand. Tell your doctor right away if you have pain or numbness in your hand or arm, tears in the skin of your treated finger or hand, trouble bending the finger after the swelling goes down, or bleeding at the injection site.
- Collagenase clostridium histolyticum may cause infection. Tell your doctor right away if you have a fever, chills, or increasing redness or swelling of your hand.

If you are receiving collagenase clostridium histolyticum for Peyronie's disease:

- Collagenase clostridium histolyticum may cause penile fracture (corporal fracture) or other serious injury to the penis. It may damage the tubes in your penis (corpora) during erection after receiving collagenase clostridium histolyticum. Call your doctor right away if you have a popping sound or sensation in an erect penis, sudden loss of the ability to maintain an erection, bruising, swelling, or pain in your penis, trouble urinating or blood in your urine.
- Tell your doctor right away if you have sudden lower back pain moving to your legs, feet, arms, or chest, or difficulty in walking after receiving collagenase clostridium histolyticum.
- You may take over-the-counter (OTC) pain medicines if you have mild to moderate pain in your penis.

Collagenase clostridium histolyticum 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 collagenase clostridium histolyticum.

Collagenase clostridium histolyticum may cause bleeding or bruising at the injection site. Tell your doctor if you have blood clotting problems before receiving collagenase clostridium histolyticum.

Fainting or near fainting may occur after you receive collagenase clostridium histolyticum. 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.

## Collagenase clostridium histolyticum side effects

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

- Bruising or bleeding at the injection site
- swelling of the hands
- tearing of the skin

More common—Peyronie's disease

- Itching, pain, redness, swelling, or bruise of the penis
- popping sound or sensation in an erect penis

Less common—Peyronie's disease

- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- painful sexual intercourse

Incidence not known—Dupuytren's contracture

- Bone pain
- dizziness
- fainting
- lower back or side pain
- painful, swollen joints

Incidence not known—Peyronie's disease

- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- difficult or labored breathing
- dizziness
- fainting
- lower back pain, possibly radiating to the legs, feet, arms, or chest
- muscle spasms

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

- Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, lumps, numbness, rash, scarring, stinging, tingling, or ulceration at the injection site
- bruise
- flushing, redness of the skin or unusually warm skin at the injection site
- itching, pain, swelling, or tenderness at the injection site
- swollen, painful, or tender lymph glands in the neck or armpit

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.

Collagenase clostridium histolyticum side effects (more detail)

## More about collagenase clostridium histolyticum

- Check interactions
- Reviews (92)
- Side effects
- Dosage information
- During pregnancy
- Drug class: miscellaneous uncategorized agents
- En español

### Patient resources

- Drug Information
- Collagenase clostridium histolyticum-aaes Subcutaneous (Advanced Reading)
- Collagenase (Systemic)

#### Other brands

Xiaflex, Qwo

### Professional resources

- Prescribing Information

### Related treatment guides

- Cellulite
- Dupuytren's contracture
- Peyronie's Disease

## Further information

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

Medical Disclaimer