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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
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
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Treating your curved erection with XIAFLEX®

There are 2 equally important parts of treatment with XIAFLEX®

If you and your urologist decide that XIAFLEX® (collagenase clostridium histolyticum) is right for you, you'll partner up to do these 2 things:

  • Injection icon
    A series of in-office injections with XIAFLEX® To help weaken and break down the Peyronie's plaque (a bump of scar tissue under the skin of the penis) that's causing your curved erection, your urologist or a trained urology healthcare professional (HCP) will inject XIAFLEX® directly into the plaque that is causing your penis to curve.
  • Hand icon
    Gentle stretching and straightening activities, also known as penile modeling To help reduce the curve in your erection and straighten the shaft of your penis, your HCP will stretch and straighten your penis in-office to elongate your treated plaque and you'll perform similar activities at home.

Every part of treatment is important to get the best possible results.

This is the treatment schedule for XIAFLEX® injections and penile modeling

It took time for the complex plaque that's causing your curved erection to form, and it'll take time to break it down.

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

You will book 3 separate office visits for each treatment cycle

Injection icon

Visit 1

Injection 1

Timeline icon for 1 to 3 days

Wait 1–3 days

Injection icon

Visit 2

Injection 2

Timeline icon for 1 to 3 days

Wait 1–3 days

Hand icon

Visit 3

HCP will stretch & straighten
your penis

House icon

At Home

You stretch & straighten your penis daily

Timeline icon for 6 weeks

About 6 weeks

Avoid sexual activity during these times:

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

Your HCP will let you know how many treatment cycles are right for you. The number of cycles needed to break down your Peyronie's plaque depends on a variety of factors, like:

  • The degree of your curved erection
  • The size and density of your plaque
  • Staying on schedule with your injections
  • Doing your daily stretching and straightening activities between each treatment cycle

Be sure to schedule all of your appointments for XIAFLEX® when you first start treatment.

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In clinical trials, 80% of men treated with XIAFLEX® received all 4 treatment cycles.

Curved couches representing percentage of men in clinical studies for XIAFLEX® who received all 4 treatment cycles Curved couches representing percentage of men in clinical studies for XIAFLEX® who received all 4 treatment cycles

Penis stretching and straightening activities after each treatment cycle with XIAFLEX®

In addition to staying on track with HCP appointments for XIAFLEX®, you have a very important job to do at home.

For 6 weeks after each treatment cycle with XIAFLEX®, you'll need to take a few minutes each day to do penile modeling—gentle stretching and straightening activities for your penis. When paired with injections of XIAFLEX®, these activities help to break down your Peyronie's plaque and help reduce the curve in your erection.

Your HCP will show you how to do these activities, but here's a helpful how-to guide that you can refer back to at home.

Penis stretching activity

Gently stretch your penis 3 times each day when it is not hard (erect).

Penis stretching Step 1 Penis stretching Step 2 Penis stretching Step 3

With 1 hand, hold the tip of your penis with your fingers. With your other hand, hold the base of your penis with your fingers.

Gently pull your penis away from your body to its full length and hold the stretch for 30 seconds.

Let go of the tip of your penis and let your penis return to its normal length.

Remember:

  • Only stretch your penis if it is not hard
  • Try to spread these 3 stretching sessions out over the course of your day

Penis straightening activity

Gently straighten your penis 1 time each day when it is erect unrelated to sexual activity (spontaneous erection).

Penis straightening Step 1 Penis straightening Step 2 Penis straightening Step 3

With 1 hand, hold your erect penis.

With your other hand, gently bend your penis in the opposite direction of the curve.

Hold the penis in this more straightened position for 30 seconds, then let go.

Remember:

  • Only straighten your penis if you have an erection that happens without any sexual activity
  • Bending your penis should not cause any pain or discomfort

Treatment with XIAFLEX® is a partnership between you and your urologist.

What to expect during and after treatment with XIAFLEX®

Important things to remember during treatment

As with any medicine, there are important things to do and not do during treatment with XIAFLEX®.

Be sure to follow these instructions throughout your treatment:

  • Bandage iconYour penis may be wrapped with a bandage after each injection Your HCP will tell you when to take the bandage off
  • Stomach muscles iconAvoid situations that may cause you to strain your stomach (abdominal) muscles such as straining during bowel movements
  • Vacuum erection iconDo not use a vacuum erection device during your treatment with XIAFLEX®
  • Prohibition iconAvoid sexual activity during these times Between the first and second injections of each treatment cycle and for at least 4 weeks after the second injection of each treatment cycle, and after any pain and swelling have gone away

You may experience side effects after your injections

It's common to have these reactions at or near the site where XIAFLEX® was injected into your penis:

  • Swelling
  • Bruising
  • Pain

These are not all of the possible side effects with XIAFLEX®. For more information, ask your HCP.

Call your HCP 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
  • Severe pain in your penis
  • Severe purple bruising and swelling of your penis
  • Difficulty urinating or blood in the urine

If you have any other questions about what to expect during treatment with XIAFLEX®, it's a good idea to ask your HCP.

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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.

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.

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.

Click for full Prescribing Information, including Boxed Warning and Medication Guide.