collagenase clostridium histolyticum

Pronunciation: KOL a JEN ase klos TRID ee um HIS toe LIT ik um

Brand: Xiaflex

What is the most important information I should know about collagenase clostridium histolyticum?

Collagenase clostridium histolyticum can damage a nerve, tendon, or ligament in the hand the medicine is injected into. After the swelling from your injection goes down, call your doctor if you have numbness, tingling, increased pain, trouble bending your finger toward your wrist, or if you have new or worsened movement problems in your treated hand.

This medicine may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have bruising and swelling of your penis, pain when you urinate, blood in the urine, sudden erection problems, or a "popping" sound or sensation in your penis during an erection.

What is collagenase clostridium histolyticum?

Collagenase clostridium histolyticum is used to treat Dupuytren's contracture in adults. This condition causes an abnormal thickening of the tissue in the palm of the hand. This condition may get worse over time and form a "cord" in your palm, causing a permanent bend in your finger.

Collagenase clostridium histolyticum is also used to treat a related condition called Peyronie's disease in adult men. This condition causes scar tissue or "plaque" to develop under the skin of the penis, resulting in an abnormal curving of the penis during erection.

Collagenase clostridium histolyticum for Peyronie's disease is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Collagenase clostridium histolyticum may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving collagenase clostridium histolyticum?

You should not use collagenase clostridium histolyticum if you are allergic to it. This medicine should not be used to treat Peyronie's disease that affects the urethra (the tube for passing urine out of your bladder).

Tell your doctor if you have ever had:

  • a bleeding or blood clotting disorder, such as hemophilia;
  • received collagenase clostridium histolyticum to treat another condition; or
  • any other medical problems.

It is not known if collagenase clostridium histolyticum will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

How is collagenase clostridium histolyticum given?

This medication is injected directly into the "cord" of the affected hand or into a "plaque" of the penis. A healthcare provider will give you this injection. Follow your doctor's instructions very carefully.

For Dupuytren's contracture:

  • Do not bend or straighten the fingers of the treated hand until your doctor tells you to.
  • Keep the treated hand elevated until bedtime.
  • You may need to wear a splint on your hand for a short time to keep your fingers straight. You may also need to perform daily finger exercises.
  • One to 3 days after injection into your hand, your doctor will need to examine the hand to see if your condition has improved.

For Peyronie's disease:

  • Your penis may need to be wrapped in a bandage for a short time after each injection. Follow your doctor's instructions about how long to wear the bandage.
  • One to 3 days after your second injection, your doctor will perform a stretching procedure to help straighten the curve in your penis.
  • You may also need to perform gentle exercises to stretch and straighten the penis at home. Carefully follow all directions about how to perform these exercises.
  • You should not have any sexual activity between the first and second injections and for at least 4 weeks after your second injection and after any pain or swelling in your penis has gone away.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your collagenase clostridium histolyticum injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving collagenase clostridium histolyticum?

Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.

Avoid situations where you may strain your stomach muscles, such as straining during bowel movements.

What are the possible side effects of collagenase clostridium histolyticum?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Collagenase clostridium histolyticum can damage a nerve, tendon, or ligament in the hand the medicine is injected into. Call your doctor at once if you have:

  • fever, chills, increased redness, or swelling;
  • numbness, or tingling in the treated finger; or
  • trouble bending the injected finger after the swelling decreases.

Collagenase clostridium histolyticum may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have:

  • bruising and swelling of your penis;
  • pain when you urinate, blood in the urine;
  • sudden erection problems; or
  • a "popping" sound or sensation in your penis during an erection.

Also call your doctor at once if you have:

  • sudden back pain, chest pain, or problems walking after an injection; or
  • feeling like you might pass out (even while lying down).

Common side effects may include:

  • swelling, bruising, bleeding, pain, or tenderness where the medicine was injected;
  • swollen glands in your elbow or underarm;
  • itching, redness, or warmth of the skin;
  • cracked skin;
  • underarm pain;
  • pain or tenderness in your treated hand;
  • bruising of the penis or scrotum, erection problems; or
  • discoloration of the skin on your penis, bruising or blisters where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs can affect collagenase clostridium histolyticum?

Tell your doctor about all your other medicines, especially:

  • a blood thinner --warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect collagenase clostridium histolyticum, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about collagenase clostridium histolyticum.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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