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FULL PRESCRIBING INFORMATION / MEDICATION GUIDE IMPORTANT SAFETY INFORMATION / OTHER CONDITION
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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Treatment with XIAFLEX® can take up to 24 weeks. Read on to learn more about getting treated with XIAFLEX®, including how to prepare for your appointment, how XIAFLEX® is administered, and what you’ll need to do after you receive XIAFLEX®.

Planning for your appointment

You may feel embarrassed about discussing a curved erection with your HCP. But remember, your HCP is familiar with this condition, which could be Peyronie's disease.

If your HCP says you do have Peyronie’s disease and a plaque that can be felt, then ask if XIAFLEX® could be right for you.

Here are suggested questions you may want to discuss:

  1. Why do I have a curved erection?
    • Is it Peyronie’s disease?
  2. If I have Peyronie's disease, is XIAFLEX® right for me?
    • Is the curve of my erection greater than 30 degrees?
    • Do I have a plaque that can be felt?
    • Does the plaque involve the urethra (the tube in the penis that urine flows through)?
      • Do not receive XIAFLEX® if you have been told by your HCP that the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra)
  3. What are the possible side effects?
  4. Are there other FDA-approved treatments for Peyronie's disease?
  5. What is involved in treatment with XIAFLEX®?

  6. Are you trained to administer XIAFLEX®? If not, can you refer me to someone who is?

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XIAFLEX® is an in-office, nonsurgical procedure

XIAFLEX® can be administered right in your HCP’s office. After the HCP administers a local anesthetic, if desired, XIAFLEX® is injected directly into the plaque that is causing your erect penis to curve. XIAFLEX® helps break down the plaque.

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

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

What should I expect from treatment with XIAFLEX®?

XIAFLEX® should be injected into the plaque by an HCP who is trained and experienced in treating adult men with Peyronie’s disease. XIAFLEX® is injected directly into the plaque that is causing your erect penis to curve.

  • XIAFLEX® may be given in up to 4 treatment cycles over the course of 24 weeks
  • In each treatment cycle, you will receive 2 injections of XIAFLEX® on separate days, 1 to 3 days apart
  • Do not have sex or any other sexual activity between the first and second injections of a treatment cycle
  • 1 to 3 days after the second injection of XIAFLEX®, you will need to return to your HCP's office for a manual procedure that will stretch and help straighten your penis. Your HCP will tell you exactly when to come back for this
  • In addition, you will perform at-home stretching and straightening activities on your penis for approximately 6 weeks after the manual procedure. See A key part of your overall treatment plan with XIAFLEX®, below
  • Do not have sex or have any other sexual activity for at least 2 weeks after the second injection of a treatment cycle with XIAFLEX® and after any pain and swelling has gone away

Your HCP will determine how many treatment cycles are appropriate. After each injection, your penis may be wrapped with a bandage. Your HCP will tell you when to take the bandage off.

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A key part of your overall treatment plan with XIAFLEX®

Penile modeling activities

Your role at home — Your HCP will show you how to stretch and straighten your penis the right way at home after each treatment cycle. You will need to take a few minutes each day to perform gentle stretching and straightening penile modeling activities on your penis, closely following your HCP's directions.

There are 2 types of penile modeling activities:

  • The first is a gentle stretching activity to be performed when the penis is not hard (erect)
  • The second is a gentle straightening activity, which should be performed when the penis is erect without any sexual activity

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

Daily stretching

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

  • 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

Helpful hint
The stretching activity can be done any time of day when you don't have an erection. Establishing a routine may make it easier to remember, so try to do the stretching activity at the same time and place each day. Giving yourself privacy may allow you to feel more comfortable and less rushed.

Daily straightening

Gently straighten your penis 1 time 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.

  • With 1 hand, hold your 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

Helpful hint
Spontaneous erections can be more common in the morning, just as you are waking up. This might be a good time for you to do your straightening activity.

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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 2 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.

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.