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Description

Collagenase clostridium histolyticum injection is used to treat Dupuytren's contracture with a palpable cord in adults.

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

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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.

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.

Drug Interactions

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:

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

Proper Use

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 of the contracture of your hand.

Precautions

It is very important that you return to your doctor the next day. This will allow your doctor to see the injected hand, and to do a possible finger extension procedure to disrupt the cord.

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.

Using this medicine 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, trouble bending the finger after the swelling goes down, or bleeding at the injection site.

This medicine may cause infection. Tell your doctor right away if you have a fever, chills, or increasing redness or swelling of your hand.

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 this medicine. Wear the splint at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your doctor.

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:

• Bruising or bleeding at the injection site
• Swelling of the hands
• Tearing of the skin

• 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:

• 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.

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