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DEL + MELISSA’S STORY

(On Screen Text)
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.

Del:

For as long as I can remember, it's been my nature to take control of the situation, and manage and control what's happening. But since retirement I’ve come to understand that patience is a virtue that allows us to take the time to understand our situation and ultimately to decide what's right for us.

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

My name is Del. I'm 70 years old, I retired in 2008 and I've been married to my wife Melissa for almost 45 years.

Melissa:

We live here in Oxnard, California near the beach. We have 2 daughters and 3 grandsons, and we're enjoying the retired life.

Del:

Well, I guess first and foremost both of us like to do Fiber Arts. Melissa started weaving as a girl. Her mother was a weaver. The loom we have in our house is her mother's loom and I actually started knitting way back when I was having therapy for a broken hand. And then when we lived in New Guinea where there was no TV or radio that's what you did. Besides our volunteer activities, we like to play golf together, it's something we can do together where my being so much taller than she is doesn't really matter.

Melissa:

Del and I really enjoy walking on the beach together and playing golf together, but we also are world travelers. Because of Del’s career we’ve lived in 7 different countries.

Del:

One of the things I discovered early on in my life was that I really didn't like sitting behind a desk doing the same thing over and over again. And so luckily I was able to find a career in the oil industry that let me go from project to project and gave us the opportunity to live overseas. And in doing that I was responsible for managing the details, anticipating what could go wrong and then having a plan in place when it did. Then later after I retired I became a consultant and for the first time in my working career people didn't have to do what I recommended and I found that very frustrating, but I also think it gave me an appreciation for patience, and it really helped me to deal with what I understood eventually was Peyronie's disease.

For many years I had a small lump in my penis and it was not a problem and didn't cause me any worry, but all of a sudden this curvature started to develop and it got fairly significant in a relatively short period of time and I was very concerned about it.

Melissa:

And we thought that something had to be done. So I got on the internet and I typed in “curved penis” and lo and behold I got a lot of information. When Del got home that night I said Del I think I found what could be wrong.

Del:

So I contacted and made an appointment with a local urologist who diagnosed it as Peyronie’s disease. He also told me that he wasn't the guy to take care of it and referred me to a specialist. Well, I did some research on that specialist and found that his primary mode of treatment was surgery. This wasn't something I was really excited about and so I went looking for another option and my wife came up with a name of another urologist so I went to see the doctor and after some testing decided that yes, you're a candidate for a nonsurgical procedure and we can treat this with XIAFLEX. I was counseled on the benefits and the risks of the treatment, as well as my role in it—and decided to proceed.

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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

(On Screen Text - Shown during dialogue below)
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.

Del:

I made my appointment and shortly after had my first injection. You know I really enjoyed the doctor and his staff. They were fantastic. I went through the doctor's recommended course of treatment, did my at home modeling and everything came out as it was explained to me.

Melissa:

I was really pleased with the experience Del had throughout his treatment journey.

Del:

And here we are now. I finished my treatment with XIAFLEX and I’m very happy with the result.

I often wonder if my Peyronie's disease had happened a decade or so ago how would I have dealt with it? Would I have found the right physician and the right course of treatment for me? I really don't think so. But we’re all human and sometimes life throws challenges at you that you're not prepared to deal with, but we have to step up to it. But if you're like me and you think you might have Peyronie's disease, you're not alone. There are lots of other men in the world that are having this issue. Find a urologist that you're comfortable with and who’s experienced and if they do diagnose you, take the time to understand your options and go ahead— it’s worth your patience.

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.