XIAFLEX- collagenase clostridium histolyticum
Endo Pharmaceuticals Inc.
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Medication Guide XIAFLEX® (Zī a flex) (collagenase clostridium histolyticum) For injection, for intralesional use |
XIAFLEX is approved for two uses: Dupuytren's contracture and Peyronie's disease. Information is provided separately for each use. Use for treating Dupuytren's contracture is described first, followed by use for treating Peyronie's disease. |
Read this Medication Guide before you receive XIAFLEX for the treatment of Dupuytren’s contracture and each time you get an injection. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. |
What is the most important information I should know about XIAFLEX for the treatment of Dupuytren’s contracture? XIAFLEX may cause serious side effects, including:
Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:
4. Fainting: Fainting or near fainting can happen in people who receive XIAFLEX, especially following finger procedures. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. |
What is XIAFLEX? XIAFLEX is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt. |
Who should not receive XIAFLEX? Do not receive XIAFLEX if you:
Talk to your healthcare provider before receiving this medicine if you have any of these conditions. |
What should I tell my healthcare provider before receiving XIAFLEX? Before receiving XIAFLEX, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. |
How will I receive XIAFLEX?
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What are the possible side effects of XIAFLEX? XIAFLEX may cause serious side effects, including:
The most common side effects with XIAFLEX for the treatment of Dupuytren’s contracture include:
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
General information about the safe and effective use of XIAFLEX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about XIAFLEX. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about XIAFLEX that is written for health professionals. For more information, go to www.XIAFLEX.com or call 1-800-462-3636. |
What are the ingredients in XIAFLEX? Active ingredient: collagenase clostridium histolyticum Inactive ingredients: hydrochloric acid, sucrose, and tromethamine. The diluent contains: calcium chloride dihydrate in 0.9% sodium chloride This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by: Manufactured by: US License No. 1816 US Patent Nos. 7,811,560 and 6,022,539 |
06/2022
Medication Guide XIAFLEX®(Zī a flex) (collagenase clostridium histolyticum) For injection, for intralesional use |
XIAFLEX is approved for two uses: Dupuytren's contracture and Peyronie's disease. Information is provided separately for each use. Use for treating Dupuytren's contracture is described on the previous pages, and use for treating Peyronie’s disease is described below. |
Read this Medication Guide before you receive XIAFLEX for the treatment of Peyronie’s disease and each time you get an injection. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. Your healthcare provider will also talk to you about receiving XIAFLEX for the treatment of Peyronie’s disease using the “What You Need to Know About XIAFLEX Treatment for Peyronie’s Disease: A Patient Guide”. You can ask your healthcare provider for a copy of the Patient Guide. |
What is the most important information I should know about XIAFLEX for the treatment of Peyronie’s Disease? XIAFLEX can cause serious side effects, including: 1. Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.
Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above. Do not have sex or any other sexual activity between the first and second injections of a treatment cycle. Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away. XIAFLEX for the treatment of Peyronie’s disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the XIAFLEX REMS Program go to www.XIAFLEXREMS.com or call 1-877-313-1235. 2. Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:
3. Back pain reactions. After receiving an injection of XIAFLEX for Peyronie’s disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less but may last longer. Tell your healthcare provider right away if you have sudden back pain, chest pain, or have a hard time walking after an injection. 4. Fainting: Fainting or near fainting can happen in people who receive XIAFLEX, especially if they have severe penile pain. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away. |
What is XIAFLEX? XIAFLEX is a prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started. It is not known if XIAFLEX is safe and effective in children under the age of 18. |
Who should not receive XIAFLEX? Do not receive XIAFLEX if you:
Talk to your healthcare provider before receiving this medicine if you have any of these conditions. |
What should I tell my healthcare provider before receiving XIAFLEX? Before receiving XIAFLEX, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. |
How will I receive XIAFLEX?
Tell your healthcare provider right away if you have trouble stretching or straightening your penis, or if you have pain or other concerns. How to gently stretch your penis: Gently stretch your penis 3 times a day. Only stretch your penis if your penis is not hard (erect).
How to gently straighten your penis: Gently straighten your penis 1 time a day. Only straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection). Bending your penis should not cause any pain or discomfort.
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What should I avoid while receiving XIAFLEX? Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements. |
What are the possible side effects of XIAFLEX? XIAFLEX can cause serious side effects, including: See “What is the most important information I should know about XIAFLEX for the treatment of Peyronie’s disease?”
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The most common side effects with XIAFLEX for the treatment of Peyronie’s disease include:
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
General information about the safe and effective use of XIAFLEX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about XIAFLEX. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about XIAFLEX that is written for health professionals. For more information, go to www.XIAFLEX.com or call 1-800-462-3636. |
What are the ingredients in XIAFLEX? Active ingredient: collagenase clostridium histolyticum
Inactive ingredients: hydrochloric acid, sucrose, and tromethamine. The diluent contains: calcium chloride dihydrate in 0.9% sodium chloride Distributed by: Manufactured by: US License No. 1816 US Patent Nos. 7,811,560 and 6,022,539 |
06/2022