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ED’S STORY

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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.

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Ed’s Story
Actual patient with Peyronie’s disease and spouse who were compensated for their time

Ed:

One day I was sitting at my desk and I got a phone call—a lifelong friend, a guy I knew from college was in a very bad way. A light came on in my head that it is so important to be passionate about something and to do what you love.

My name is Ed and I am a director and a director of photography in the television and film business. I'm 70 years old, I've been married for 35 years, I have two daughters, they're lovely, they’re successful, and they make me very happy.

I'm very fortunate to do what I do. I've been doing it for quite a while and it's something I really, really love. The camera takes us to all different places—the opportunities to see the world, the opportunities to meet other people, to go places where you normally would never get to go comes with the territory. I put a lot of passion and a lot of attitude and interest into what I do. So a long time ago in the seventies I was a sculptor. I had been toying with the idea of getting back into sculpting again and actually had a couple of pieces of wood that I kept talking about doing something with. I realized if I was going to do it, I should do it now. So, I went out to the shed and I dragged one of those pieces of wood out that I've been talking about for 8,9, 10 years and I started sculpting again. The thing that I love about the sculpture is it really takes me away because I get totally involved in it, the physicality of taking a raw material in finding what’s in it—letting the wood talk to you… the discovery that comes from that brings me to a place that I haven't been in a really long time.

Time is short, it's a very limited commodity and if you can take action to do something you should take that action and that really related to my Peyronie's disease. When I discovered that I had it I immediately went to find out what to do about it as opposed to saying I don't know what to do about it or having negative feelings about it or feeling helpless about it.

When I injured my penis it was very painful. Within a month or so of that injury I started to develop a curvature. I was a little alarmed by that needless to say I wasn't sure whether I should ignore it, or whether I should in fact find out what was going on with it and I chose the latter. I mean let's face it this is a very sensitive topic and it’s a piece of my masculinity so I went to my general practitioner who said you need to go see a urologist and went in for an examination, we discussed the potential benefits and the potential risks of the therapy and it was determined that I was a viable candidate for XIAFLEX. They also explained to me that this is really a team effort and that I will participate in this treatment.

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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.

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 products. 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® should be injected into the plaque by a specialist who is trained and experienced in treating adult men with Peyronie’s disease.

  • A treatment course of XIAFLEX® consists of up to 4 treatment cycles 6 weeks apart
  • In each treatment cycle, you will receive 2 injections of XIAFLEX® on separate days and in-office penile modeling, 1 to 3 days apart, followed by at-home modeling activities
  • Your urologist will determine how many treatment cycles are appropriate

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In clinical trials, men treated with XIAFLEX® experienced improvement in their erectile curvature between 11-17% compared to placebo.

XIAFLEX® may not work for everyone.
Effectiveness may vary between patients.

Ed:

So I did the full course, I did 8 injections over 24 weeks and considering the sensitivity of the issue, to feel that the person and the people that are actually treating you are really with you in this, I felt that they really had my back. So by the end of my treatment I was really, really happy with the reduction in the curvature. There was a point where I thought possibly the surgery was the only option. The passions that I have in my life, the things that I hold near and dear, they're just really important and a way that I kinda define myself and the way I feel good about life and when this problem came about it moved me to immediately try to get treatment. I felt that it was really important for me to take advantage of what was available to me and for me to search out and find what I could do to make this better. There’s action you can take to improve your situation and the most important thing is to search them out and do it. If you have Peyronie's disease, you're not alone. You don't have to be alone in this. You should talk to your urologist, you should find out what your options are and take charge of it.

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.