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UNDERSTANDING PEYRONIE’S DISEASE AND XIAFLEX

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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.
SELECT IMPORTANT SAFETY INFORMATION
Do not receive XIAFLEX if:

  • the Peyronie’s plaque to be treated involves the “tube” that your urine passes through (urethra).
  • you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including 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.

Please see Important Safety Information for XIAFLEX® continued in this video.

Understanding Peyronie's disease and XIAFLEX collagenase clostridium histolyticum. This video may be a valuable resource for you whether you're just interested in learning more about your condition or are beginning your treatment with XIAFLEX. Here you'll find out more about if your erectile curvature could be Peyronie's disease and if so how XIAFLEX may be able to treat it. If prescribed, you'll also find out what you can do during treatment. In addition to this video please also review the medication guide and patient counseling tool provided by your urologist.

While having a slightly curved erection may be normal and may not be a cause for concern, sometimes development of fibrous scar tissue or plaque inside the penis can cause an abnormal bend with or without pain during an erection. This erectile curvature may be Peyronie's disease. You're not alone though, in fact up to 13% of men may have Peyronie's disease in the United States.

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*Based on a survey of more than 11,000 adult men in the US with diagnosed Peyronie’s disease, a history of seeking care for the disease, or having related symptoms

Although the exact cause is unknown, it is thought to be a result of an abnormal wound healing. This means that injury or damage to the outer penile tissues activates a scarring process that goes well beyond the normal healing process. Peyronie's disease may be a progressive condition which means the size of the plaque and degree of curvature can get worse over time and are unlikely to go away on their own. The good news is it's a condition that may be improved with treatment.

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Individual results may vary

Based on your degree of erectile curvature and the presence of a lump or bump in your penis your urologist may recommend medication or surgery. The treatment option we’ll discuss in more detail here is XIAFLEX, the only FDA approved nonsurgical prescription treatment option 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.

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Please see important Safety Information for XIAFLEX® continued in this video.

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Select Important Safety Information

Do not receive XIAFLEX if:

  • the Peyronie’s plaque to be treated involves the “tube” that your urine passes through (urethra).
  • you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

Penile fracture (corporal rupture) or other serious injury to the penis. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture. Please see important safety information for XIAFLEX continued in this video.

XIAFLEX is administered in a urologist office. First, in order to locate the scar tissue or plaque and identify the treatment area your specialist will induce an erection. When the penis is in a flaccid state your specialist may administer a local anesthetic. XIAFLEX is then injected directly into the plaque with a penis in a flaccid state to help break down the plaque. It's important to remember that it's common for swelling, bruising and pain to occur at or near the injection site. Call your healthcare provider right away if you have any of the following symptoms of corporal rupture or serious injury to the penis: a popping sound or sensation in an erect penis, sudden loss of the ability to maintain an erection, pain in your penis, purple bruising and swelling of your penis, difficulty urinating or blood in the urine.

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Please see important Safety Information for XIAFLEX® continued in this video.

A treatment course of XIAFLEX consists of up to 4 treatment cycles 6 weeks apart. Throughout treatment you and your doctor will discuss how many cycles are appropriate for you. The treatment is dependent on two essential components, the injection of XIAFLEX and stretching and strengthening activities. In each treatment cycle you will receive two injections of XIAFLEX on separate days approximately 1 to 3 days apart.

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle and for 4 weeks after the second injection. Your health care providers will also tell you when you can resume sexual activity after each treatment cycle.

Approximately 1 to 3 days after the second injection of XIAFLEX you will need to return to your specialist’s office for a manual procedure that will stretch and help straighten your penis. Your healthcare provider will tell you exactly when to come back for your next visit.

Avoid situations that may cause you to strain your stomach (abdominal) muscles such as straining during bowel movements. Do not use a vacuum erection device during your treatment with XIAFLEX.

You play an essential role in your xiaflex treatment for approximately six weeks at home after each treatment cycle by performing gentle stretching and strengthening activities. You will need to take a few minutes each day to perform these stretching and straightening activities on your penis, closely following the medication guide and your specialist’s directions. To get more detailed instructions, download the at-home stretching and straightening activities guide in the resources section of XIAFLEX.com.

Remember results are different for everyone.

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.

Important Safety Information

Do not receive XIAFLEX if:

  • the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra).
  • you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

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.

    • After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery.

    Symptoms of corporal rupture or other serious injury to your penis may include:

    • a popping sound or sensation in an erect penis
    • sudden loss of the ability to maintain an erection
    • pain in your penis
    • purple bruising and swelling of your penis
    • difficulty urinating or blood in the urine

    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.

  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:

    • hives
    • swollen face
    • breathing trouble
    • chest pain
    • low blood pressure
    • dizziness or fainting

  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 hard time walking after an injection.

  4. Fainting. Fainting (passing out) or near fainting can happen in men 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.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. 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 medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

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.

Do not use a vacuum erection device during your treatment with XIAFLEX.

XIAFLEX can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

The most common side effects with XIAFLEX for the treatment of Peyronie's disease include:

  • a small collection of blood under the skin at the injection site (hematoma)
  • swelling at the injection site or along your penis
  • pain or tenderness at the injection site, along your penis and above your penis
  • penis bruising
  • itching of your penis or scrotum (genitals)
  • painful erection
  • erection problems (erectile dysfunction)
  • changes in the color of the skin of your penis
  • blisters at the injection site
  • pain with sex
  • a lump at the injection site (nodule)

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. You may report side effects to FDA at 1-800-FDA-1088.

Click for full Prescribing Information, including BOXED WARNING and Medication Guide.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Visit XIAFLEX.com if you’re looking for specialists nearest you who you can talk to about your erectile curvature or if you want additional resources and information. Thank you for watching this informational video on Peryonie’s disease and treatment with XIAFLEX. We hope that it has been educational for you and we wish you the best moving forward.