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Collagenase clostridium histolyticum

Generic Name: collagenase clostridium histolyticum (kol-AJ-e-nase klos-TRID-ee-um HIS-toe-LIT-ik-um)
Brand Name: Xiaflex

If you are using collagenase clostridium histolyticum to treat Peyronie disease:

  • Collagenase clostridium histolyticum may cause permanent damage to the tubes in the penis, causing them to break during an erection (corporal rupture or penile fracture). Collagenase clostridium histolyticum may also cause blood vessels in the penis to break, causing blood to collect under the skin. Contact your doctor right away if you experience a popping sound or sensation in an erect penis; sudden inability to maintain an erection; pain, bruising, or swelling of the penis; trouble urinating; or blood in the urine.
  • Collagenase clostridium histolyticum is only available for the treatment of Peyronie disease through a special program called Xiaflex Risk Evaluation and Mitigation Strategy Program (REMS). Talk to your doctor to be sure that you are enrolled in this program and that you meet all of its requirements.

Collagenase clostridium histolyticum is used for:

Treating Dupuytren contracture. It is also used to treat Peyronie disease.

Collagenase clostridium histolyticum is a collagenase enzyme. It works by helping to break down the collagen, which allows the fingers or penis to straighten.

Do NOT use collagenase clostridium histolyticum if:

  • you are allergic to any ingredient in collagenase clostridium histolyticum or to other collagenase products
  • the Peyronie plaque to be treated involves the urethra (the tube that urine passes through)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2013 Drug News Round-Up: Top 20 Stories

Before using collagenase clostridium histolyticum:

Some medical conditions may interact with collagenase clostridium histolyticum. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have bleeding or clotting problems
  • if you have received collagenase clostridium histolyticum to treat another condition

Some MEDICINES MAY INTERACT with collagenase clostridium histolyticum. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that thin the blood (eg, aspirin, clopidogrel, prasugrel, warfarin) because the risk of bleeding or bruising at the injection site may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if collagenase clostridium histolyticum may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use collagenase clostridium histolyticum:

Use collagenase clostridium histolyticum as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Collagenase clostridium histolyticum comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get collagenase clostridium histolyticum refilled.
  • Collagenase clostridium histolyticum is given as an injection at your doctor's office, hospital, or clinic.
  • Your doctor may wrap the affected area with a bandage after you receive your injection.
  • If you are using collagenase clostridium histolyticum to treat Dupuytren contracture:
    • Limit motion of the treated finger and keep the treated hand elevated until bedtime.
    • Do not bend or straighten the fingers of your injected hand until your doctor tells you to. This will help prevent the medicine from leaking out of the cord.
    • Do NOT try to straighten the finger yourself.
  • If you are using collagenase clostridium histolyticum to treat Peyronie disease:
    • Your health care provider will give you a Patient Guide with instructions on how to stretch and form your penis at home. Read it carefully.
    • Follow your doctor's instructions on how and when to stretch your penis after each treatment cycle.
  • If you miss your dose of collagenase clostridium histolyticum, contact the doctor to set up a new appointment.

Ask your health care provider any questions you may have about how to use collagenase clostridium histolyticum.

Important safety information:

  • You will need to return to your doctor's office for an examination of the treated area as directed. Your doctor may also need to straighten the area. Do not try to straighten the affected area yourself.
  • If you are using collagenase clostridium histolyticum to treat Dupuytren contracture:
    • Do not perform normal or strenuous activities with the treated hand until your doctor tells you otherwise.
    • You will need to wear a splint at bedtime as directed by your doctor after you receive collagenase clostridium histolyticum.
    • Your doctor will give you exercises for the treated hand. Discuss any questions that you may have about these exercises with your doctor.
    • Rarely, some patients have had serious effects on other tissues of the treated hand (eg, tendon or ligament problems, nerve problems). Tell your doctor right away if you have numbness, tingling, or increased pain in the treated finger or hand after your injection or after your follow-up visit. Also tell your doctor if you have trouble bending your treated finger after the swelling goes down or if you have problems using the treated hand after your follow-up visit.
  • If you are using collagenase clostridium histolyticum to treat Peyronie disease:
    • You may have mild bruising, pain, or swelling of the penis after the injection. Contact your doctor right away if this becomes worse or you experience trouble urinating, blood in the urine, popping or cracking sounds from the penis, or sudden loss in the ability to maintain an erection.
    • Do not have sex or have any other sexual activity for at least 2 weeks after the second injection of collagenase clostridium histolyticum and after any pain and swelling has gone away.
  • Collagenase clostridium histolyticum should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using collagenase clostridium histolyticum while you are pregnant. It is not known if collagenase clostridium histolyticum is found in breast milk. If you are or will be breast-feeding while you use collagenase clostridium histolyticum, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of collagenase clostridium histolyticum:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild swelling or pain of the lymph nodes in the elbow or underarm; mild pain, redness, bruising, or bleeding at the injection site; swelling, pain, or tenderness of the affected area; warmth or redness of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness or pain in the chest; swelling of the mouth, face, lips, or tongue); blisters or a lump at the injection site; breaks in the skin or skin tears; fainting; severe or persistent pain or bleeding at the injection site; symptoms of infection (eg, fever, chills, increased swelling or redness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of collagenase clostridium histolyticum:

Collagenase clostridium histolyticum is handled and stored by a health care provider. Keep collagenase clostridium histolyticum out of the reach of children and away from pets.

General information:

  • If you have any questions about collagenase clostridium histolyticum, please talk with your doctor, pharmacist, or other health care provider.
  • Collagenase clostridium histolyticum is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take collagenase clostridium histolyticum or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about collagenase clostridium histolyticum. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to collagenase clostridium histolyticum. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using collagenase clostridium histolyticum.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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