Health Guide
Drug Guide

Collagenase clostridium histolyticum (Injection route)

Pronunciation:

KOL-a-jen-ase klos-TRID-ee-um his-toe-LIT-ik-um

Brand Names:

Dosage Forms:

Warnings:

Injection route(Powder for Solution)

Corporal rupture (penile fracture) and severe penile hematoma have been reported with use. Promptly evaluate signs or symptoms that reflect serious penile injury, as surgical intervention may be required. Collagenase clostridium histolyticum is only available through a restricted program called the Xiaflex REMS program .

Classifications:

Therapeutic

Tissue Permeability Modifier

Pharmacologic

Collagenase

Uses of This Medicine:

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 This Medicine:

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:

Allergies

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.

Children

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.

Older adults

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

Other 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.

Other interactions

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 This Medicine:

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 This Medicine:

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 types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires 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 you receive 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.

Side Effects of This Medicine:

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
lower back or side pain
painful, swollen joints

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.


Last Updated: 9/15/2016

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