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Treatment with XIAFLEX®

XIAFLEX® is the only FDA-approved, nonsurgical treatment option for appropriate patients with Peyronie's disease. You can receive XIAFLEX® right in your healthcare professional's (HCP) office.

You and your HCP will participate in 2 equally important parts of your treatment

Helps weaken and break down Peyronie's plaque

Gentle stretching and straightening activities help reduce erectile curvature and straighten the penile shaft

A treatment course of XIAFLEX® consists of up to 4 treatment cycles approximately 6 weeks apart

Set up all injection appointments at the initial consultation. Your HCP will determine how many treatment cycles are appropriate.

XIAFLEX® was not associated with shortening of penile length in clinical trials in the treatment of Peyronie’s disease
Please see Important Safety Information, below.

Treatment with XIAFLEX® is a team effort. Both you and your HCP have important roles to play. Keep reading to find out more details about these roles, the injection of XIAFLEX®, and penile modeling activities.

Working with your HCP

Visit 1:
First injection of XIAFLEX®

  • Your HCP will inject XIAFLEX® into the plaque that is causing your penis to curve
  • XIAFLEX® is given as part of a treatment cycle. In each treatment cycle, you will receive an injection of XIAFLEX®, followed by a second injection 1 to 3 days later

Visit 2:
Second injection of XIAFLEX®

  • Occurs 1 to 3 days after initial injection

Visit 3:
HCP penile modeling

  • 1 to 3 days after the second injection of XIAFLEX®, you will need to return to your HCP's office for a manual procedure called penile modeling that will stretch the plaque and help straighten your penis
A urologist and a hypothetical patient discussing treatment with XIAFLEX®

Your role at home

Daily penile modeling

  • Your HCP will show you how to stretch and straighten your penis the right way at home after each treatment cycle
  • After each treatment cycle, you will need to take a few minutes each day to perform these at-home stretching and straightening activities on your penis for about 6 weeks
  • Do not use a vacuum erection device during your treatment with XIAFLEX®

After each injection

  • Your penis may be wrapped with a bandage. Your HCP will tell you when to take the bandage off
  • It is common to see bruising and swelling after your injections with XIAFLEX®
  • While receiving XIAFLEX®, avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements

Sexual activity

    For each treatment cycle, do not have sex or engage in any other sexual activity:

  • Between the first and second injections
  • For at least 4 weeks after the second injection and after any pain and swelling has gone away

How to perform daily penile modeling activities at home

Part of your commitment to treatment means performing the 2 types of penile modeling activities (stretching and straightening).

Although these activities only take a few minutes, it is important that you follow your HCP's instructions and do them every day for about 6 weeks at the end of each treatment cycle.

Gently stretch your penis 3 times a day. Only stretch your penis if your penis is not hard (erect).

  1. With one hand, hold the tip of your penis with your fingers. With your other hand, hold the base of your penis with your fingers.
  2. Gently pull your penis away from your body to its full length and hold the stretch for 30 seconds.
  3. Let go of the tip of your penis and let your penis return to its normal length.

Stretching tip:

  • It might be helpful to set aside times during the day when you have privacy and will not be interrupted

Gently straighten your penis once a day. Only straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection). Bending your penis should not cause any pain or discomfort.

  1. With one hand, hold your erect penis.
  2. With your other hand, gently bend your penis in the opposite direction of the curve.
  3. Hold the penis in this more straightened position for 30 seconds, then let go.

Straightening tip:

  • Perform this activity in the morning if you experience a spontaneous erection
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Important Safety Information
for XIAFLEX®

Do not receive XIAFLEX® if you:
  • have been told by your healthcare provider that the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra)
  • 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

    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. For more information about the XIAFLEX® REMS Program, go to www.XIAFLEXREMS.com or call 1‑877‑942‑3539.

  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

Before receiving XIAFLEX®, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX® injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non‑prescription 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 unsure.

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.

Please see the full Prescribing Information, including Boxed Warning and Medication Guide.