Collagenase Clostridium Histolyticum, Injection

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KEY POINTS

• This medicine is given by injection to treat Dupuytren’s contracture, or Peyronie’s disease. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious problems, such as ruptured tendons or ligaments, or damage tubes or blood vessels in your penis. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: proteinase

Generic and brand names: collagenase clostridium histolyticum, injection; Xiaflex

What is this medicine used for?

This medicine is given by injection (shots) to treat

• Dupuytren’s contracture
• Peyronie’s disease with a plaque that can be felt

When used for the treatment of Peyronie’s disease, this medicine is only available through a restricted program. Your healthcare provider will explain.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding problem or if you are taking medicine to treat or prevent blood clots

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide before you receive this medicine and each time you get an injection.

For Dupuytren’s contracture:

This medicine is given by your healthcare provider. It is injected into the cord that causes your finger to bend.

Do not straighten or bend the fingers of the injected hand until your healthcare provider tells you to do so. Do not try to straighten the treated finger by yourself. You will be given a splint to wear on the treated finger. Follow your healthcare provider’s instructions carefully.

The day after the injection, you will return to your healthcare provider for a follow-up visit. Keep all appointments. Your healthcare provider may try to straighten the treated finger and give you exercises to do.

You may receive more than one treatment. Talk with your healthcare provider about this.

For Peyronie's disease:

This medicine is given by your healthcare provider. It is given as part of a treatment cycle. In each treatment cycle, you will receive an injection of this medicine, followed by a second injection 1 to 3 days later.

One to 3 days after your second injection of this medicine in a treatment cycle, you will return to your healthcare provider for a follow-up visit. Keep all appointments. Your healthcare provider may try to stretch and help straighten your penis and show you how to gently stretch and straighten your penis at home. Carefully follow your healthcare provider’s instructions.

What should I watch out for?

Peyronie's disease:

This medicine may damage the tubes or blood vessels in your penis, causing them to break during an erection. Damage to your penis might not get better. Tell your healthcare provider right away if you are not able to keep an erection all of a sudden, if you have pain, bruising, or swelling of the penis, a popping sound or feeling in an erect penis, trouble passing urine, or if you have blood in the urine.

Do not have sex for at least 2 weeks after the second injection of a treatment cycle with this medicine, or as instructed by your healthcare provider.

For Dupuytren’s contracture:

You will need to do finger exercises each day as instructed by your provider. You will also need to wear a splint. Ask your provider about daily activities with the hand that was injected with this medicine.

This medicine may cause serious problems, such as ruptured tendons or ligaments. Contact your healthcare provider right away if you have trouble bending your injected finger after the swelling goes down or if you have problems using your treated hand after your follow-up visit.

Contact your healthcare provider if your condition does not improve or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat.)

Serious for Peyronie's disease (Report these to your healthcare provider right away.): You are not able to keep an erection all of a sudden; pain, bruising, or swelling of the penis; a popping sound or feeling in an erect penis; trouble passing urine; have blood in the urine; unusual bruising or bleeding.

Serious for Dupuytren’s contracture (Report these to your healthcare provider right away.): Increased swelling, numbness, tingling, or pain in your finger or hand; tears in the skin in your treated finger or hand after your injection or after your follow-up visit; any signs of infection such as fever, chills, redness, or warmth; unusual bruising or bleeding; pain or swelling in the lymph nodes (glands) in the elbow or underarm.

Other: Pain or swelling at the injection site; itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aspirin and other salicylates
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.