Peyronie’s Disease

GET THE FACTS ABOUT A NONSURGICAL TREATMENT OPTION FOR PEYRONIE’S DISEASE

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 any collagenase or any of the ingredients in XIAFLEX.

WHAT ARE THE SYMPTOMS OF PD?

If you have PD, you may notice these symptoms:

• A bent erection with or without pain
• A bump of scar tissue under the skin of the penis called a Peyronie’s plaque
• Bothered about erection pain, erection appearance, and the impact on intercourse and on frequency of sexual activity

WHAT CAUSES PD?

The exact cause of PD is unknown, but these could likely be contributing factors:

• One or more injuries to the penis
  This can occur during athletic activities, an accident, or sex. During vigorous sex especially, the penis can accidentally bend and become injured.
• Genetics
  Men with family members who have Peyronie’s disease or other related conditions may be more likely to get it. Genetic issues in these men may result in problems healing after an injury.
• Age
  Older men may have less firm erections that can bend more easily, which may put them at higher risk for injury.

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.

ABOUT XIAFLEX® (collagenase clostridium histolyticum)

XIAFLEX is the only Food and Drug Administration (FDA)-approved nonsurgical treatment option for appropriate adult men with Peyronie’s disease.

Treatment involves a series of injections (1 to 4 treatment cycles about 6 weeks apart), given in-office by a trained urologist. When paired with daily gentle stretching and straightening of the penis, over time XIAFLEX is proven to help reduce erectile curvature. Individual results will vary.

To be considered for treatment with XIAFLEX, your doctor will need to see if you have the following 2 symptoms:

• A Peyronie’s plaque
  A bump of scar tissue under the skin of the penis that can be felt
• A bent erection
  Bent at least 30 degrees at the start of treatment

Don’t worry about figuring out these things yourself. A urologist or trained urology healthcare professional (HCP) can discuss what your treatment options are depending on your degree of curvature, and also check for the presence of a Peyronie’s plaque.

THERE ARE 2 EQUALLY IMPORTANT PARTS OF TREATMENT

PART 1
Working with your treatment team

XIAFLEX® works to help gradually break down your plaque over 1 to 4 treatment cycles, with about 6 weeks between each cycle.

Book 3 separate office visits for each treatment cycle which consists of:

VISIT 1

First injection of XIAFLEX
Your urologist will inject XIAFLEX directly into the Peyronie’s plaque to help weaken and break it down

Wait 1-3 days

VISIT 2

Second injection of XIAFLEX

Wait 1-3 days

VISIT 3

Your urologist will stretch and straighten your penis
You will return to your urologist’s office for a manual procedure called penile modeling.

PART 2
Your role at home

You will gently stretch and straighten your penis daily
For 6 weeks after each treatment cycle with XIAFLEX®, you’ll need to take a few minutes each day to do penile modeling activities (refer to pages 14 and 15 for more information).

Sexual activity

You’re probably wondering about sex. For each treatment cycle, do not have sex or engage in any other sexual activity:

• Between the first and second injections of a treatment cycle
• For at least 4 weeks after the second injection of each treatment cycle and after any pain and/or swelling have gone away

This completes 1 of 4 possible treatment cycles.

You and your urologist will determine how many cycles are appropriate for you.
Work with your treatment team to schedule your appointments for XIAFLEX in advance, and stay in touch with your urologist for any questions or concerns.

SELECT IMPORTANT SAFETY INFORMATION

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.

After each injection

Your penis may be wrapped with a bandage. Your urologist will tell you when to take the bandage off.
It’s common to see bruising and swelling, and experience pain after your injections with XIAFLEX at or near the injection site.

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

SELECT IMPORTANT SAFETY INFORMATION

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.

View Full XIAFLEX® Treatment Guide (PDF)