Skip to main content

Informational Video with Dr. Martinez

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.

(On Screen Text)
Please see Important Safety Information continued in this video and at the end.

(On Screen Text)
Daniel Martinez, MD Urology/Sexual Medicine
Dr Martinez is a paid consultant for Endo Pharmaceuticals Inc.

Dr Martinez:

Hello, I’m Dr Daniel Martinez, urologist and sexual medicine specialist.
Today, I’m going to talk to you about understanding Peyronie’s disease and XIAFLEX.

I hope this video will be a valuable resource for you, whether you’re just interested in learning more about your condition or are beginning treatment. Here, you’ll find out more about whether a bend with a bump in your erect penis, also called penile curvature, could be Peyronie’s disease and, if so, how XIAFLEX may be able to help treat it.

(On Screen Text)
WHAT TO DO DURING TREATMENT

Dr Martinez:

If you and your healthcare provider decide that XIAFLEX is appropriate for you, you’ll also learn about what you need to do during treatment.

Please review the information and resources, including the Medication Guide, accompanying this video or available at XIAFLEX.com.

While having a slight bend in your penis during an erection may be normal and may not be a cause for concern, sometimes development of scar tissue, also called the plaque, can cause an abnormal bend over time, with or without pain during an erection.

This bend with a bump in your erection may be Peyronie’s disease.

(On Screen Text)
This bend with a bump in your erection may be Peyronie’s disease

Dr Martinez:

The good news is, you’re not alone, and there are other men like you looking for answers.

(On Screen Text)
YOU ARE NOT ALONE.

Dr Martinez:

In fact, about one in ten men may have Peyronie’s disease in the United States. In my experience, I have found that many men may be embarrassed or afraid to talk about it and believe there is nothing they can do.

(On Screen Text)
~1 in 10 men may have Peyronie’s disease in the United States*
*Based on a survey of about 7,700 adult men with a Peyronie’s disease diagnosis, PD-related symptoms, or a history of seeking treatment for the condition.

Dr Martinez:

I encourage you to talk with a urologist who has experience in diagnosing and treating Peyronie’s disease to discuss available treatment options.

Now, let’s talk about why we’re here. Although the exact cause of Peyronie’s disease is unknown, it is thought to be a result of abnormal wound healing. This means that injury or damage to the penis may cause a buildup of scar tissue under the skin of the penis over time, causing a bend with a bump in your erection. Peyronie’s disease may be a gradual condition, which means the size of the scar tissue and degree of penile curvature can get worse over time and is unlikely to go away on its own.

Fortunately, it’s a condition that may improve with treatment. Based on your degree of penile curvature and the presence of a bump in your penis, your urologist may recommend medication or surgery.

(On Screen Text)
Individual results may vary.

Dr Martinez:

The treatment option we'll discuss in more detail here is XIAFLEX, the only FDA-approved nonsurgical prescription treatment for 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.

(On Screen Text)
For 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.

Dr Martinez:

It is not known if XIAFLEX is safe and effective in children under the age of 18.

(On Screen Text)
It is not known if XIAFLEX is safe and effective in children under the age of 18.

Dr Martinez:

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 may not get better after a corporal rupture.

(On Screen Text)
Please see additional Important Safety Information for XIAFLEX continued in this video.

Dr Martinez:

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

XIAFLEX is administered in a urologist’s office. In order to minimize the risk of potential complications, this should be performed by a urologist trained to administer XIAFLEX or a urology healthcare provider who is experienced in treating adult men with Peyronie’s disease.

It is important to 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; sudden back pain, chest pain, hard time walking after an injection; or hypersensitivity reactions, including anaphylaxis, hives, swollen face, breathing trouble, chest pain, low blood pressure, dizziness, or fainting.

(On Screen Text)
It is important to 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;
  • sudden back pain, chest pain, hard time walking after an injection; or
  • hypersensitivity reactions, including anaphylaxis, hives, swollen face, breathing trouble, chest pain, low blood pressure, dizziness, or fainting.

Dr Martinez:

First, in order to locate the scar tissue and identify the treatment area, your urologist may use a special medicine that will cause you to get an erection. Once your penis is no longer erect, your urologist may administer medicine that numbs the area. XIAFLEX is then injected directly into the scar tissue, where the enzymes in XIAFLEX work together to gradually weaken and help break down the scar tissue that's causing your erection to curve.

(On Screen Text)
BEGINNING TREATMENT WITH XIAFLEX

Dr Martinez:

XIAFLEX can cause serious side effects, including penile fracture (corporal rupture) or other serious injury to the penis; hypersensitivity reactions, including anaphylaxis; back pain reactions; and fainting.

(On Screen Text)
XIAFLEX can cause serious side effects, including:

  • penile fracture (corporal rupture) or other serious injury to the penis;
  • hypersensitivity reactions, including anaphylaxis;
  • back pain reactions;
  • and fainting.

Dr Martinez:

I tell all my patients that XIAFLEX treatment is a team effort between them and me. In order to have the best experience, reach out to your treating healthcare provider to help answer any questions or concerns you may have throughout your treatment journey.

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 have any other medical conditions.

A treatment course of XIAFLEX consists of up to four treatment cycles, six weeks apart. Before starting XIAFLEX treatment, you and your doctor will discuss how many treatment cycles are right for you.

(On Screen Text)
VISIT 1 - Injection 1, Wait 1-3 days, VISIT 2 - Injection 2, Wait 1-3 days, VISIT 3 - HCP will stretch and strengthen your penis, AT HOME Approx. 6 weeks - You stretch and strengthen your penis daily

Dr Martinez:

A single treatment cycle has two parts. Part one of XIAFLEX treatment is a series of in-office injections given by a trained urologist into the Peyronie's plaque, which is the bump of scar tissue under the skin of the penis. Part two of XIAFLEX treatment involves gentle penile stretching and straightening activities that your doctor will perform in the office. You will also be expected to perform these exercises daily in the comfort and privacy of your home. In each treatment cycle, you will receive two injections of XIAFLEX on separate days, approximately one to three days apart. Do not have sex or any other sexual activity between the first and second injections of a treatment cycle and for four weeks after the second injection. Your healthcare provider will also tell you when you can resume sexual activity after each treatment cycle.

The most common side effects with XIAFLEX include a collection of blood under the skin (hematoma); swelling, pain or tenderness, blisters, or lump (nodule) at the injection site; bruising; itching of your penis or genitals; painful erection; erection problems, also known as erectile dysfunction; changes in the color of the skin of your penis; and pain with sex.

(On Screen Text)
The most common side effects with XIAFLEX include:

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

Dr Martinez:

Approximately one to three 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.

(On Screen Text)
Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.

Dr Martinez:

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

(On Screen Text)
Do not use a vacuum erection device during your treatment with XIAFLEX.

(On Screen Text)
YOUR ROLE IN XIAFLEX TREATMENT

Dr Martinez:

You play an essential role in your XIAFLEX treatment. For approximately six weeks at home after each treatment cycle, you will perform gentle stretching and straightening 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, visit XIAFLEX.com or refer to the educational material provided by your healthcare provider.

(On Screen Text)
XIAFLEX.COM

Dr Martinez:

In closing, we know that men’s sexual health can be hard to talk about, but there is hope. There are treatment options available, so talk to your healthcare provide about treatment options that may be right for you.

Remember, you are not alone. Approximately one in ten men in the US have Peyronie’s disease.

(On Screen Text)
Based on a survey of about 7,700 adult men with a Peyronie’s disease diagnosis, PD-related symptoms, or a history of seeking treatment for the condition.

Dr Martinez:

By making it this far to seek out information and watching this video, you are now on the right path. Now you know that there is an FDA-approved nonsurgical treatment option out there for appropriate patients.

Tens of thousands of men have been prescribed XIAFLEX. This was the first step in your treatment journey.

(On Screen Text)
As of May 2022, more than 38,000 men have been prescribed XIAFLEX for PD. Source: Specialty Pharmacy transactions for men prescribed XIAFLEX for PD from January 1, 2014, to May 12, 2022. Data on File. DOF-XPD-30.

Dr Martinez:

Your next step is to find a urologist trained to administer XIAFLEX at XIAFLEX.com.

(On Screen Text)
XIAFLEX.COM

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.

(On Screen Text)
Daniel Martinez, MD Urology/Sexual Medicine

Dr Martinez:

Visit XIAFLEX.com to find a urologist trained to administer XIAFLEX near you.

(On Screen Text)
XIAFLEX.COM

Dr Martinez:

Thank you for watching this informational video on Peyronie’s disease and treatment with XIAFLEX. I hope that it has been educational for you, and I wish you the best moving forward.