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AT-HOME PENILE MODELING VIDEO TRANSCRIPT

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VIEWING TIPS
The following video contains material that may not be suitable for all audiences. Please be mindful of your surroundings. You may also want to use headphones while watching.

The following video contains material that may not be suitable for all audiences. Please be mindful of your surroundings. You may also want to use headphones while watching.

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HOW TO PERFORM AT-HOME PENILE MODELING (PENILE STRETCHING AND STRAIGHTENING)
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.

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.

Keep watching for Important Safety Information at the end of this video.

How to perform at-home penile modeling

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Visit 1
First injection

There are three parts to each treatment cycle with XIAFLEX:...

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1-3 days
Visit 2
Second injection

...two injections,...

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1-3 days
Visit 3
Penile modeling

...in-office penile modeling,...

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At home for 6 weeks
Daily penile modeling

...and daily at-home penile modeling.

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TREATMENT CYCLES 1 2 3 4
Your urology specialist will determine how many cycles are appropriate for you.
Do not have any sexual activity during and for at least 4 weeks after the second injection of each treatment cycle.

You may complete up to 4 cycles for a total of 8 injections to finish your treatment. The success of your treatment with XIAFLEX depends in part on your active participation. Whether you’re in the urology office or at home, every part of treatment is important to get the best possible results.

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DAILY FOR 6 WEEKS
At-home penile modeling (stretching and straightening exercises)

An important part of your role includes performing gentle penile stretching and straightening at home after each treatment cycle.

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  1. Penile Stretching
  2. Penile Straightening

A member of your urology care team will tell you exactly when to start penile modeling at home, and for how long you'll need to do it after each treatment cycle. We'll take a closer look at it in this video.

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AT-HOME PENILE MODELING EXERCISE 1:
Penile stretching
3x PER DAY
30 SECONDS
Penis is not hard or erect

The first at-home penile modeling exercise is penile stretching. You should do the stretching part of penile modeling three times per day, for 30 seconds at a time when your penis is not hard or erect.

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Hold tip of penis while holding base with other hand

Hold the tip of your penis with your thumb and index finger, while holding the base of your penis with your other hand.

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Pull penis to its full length

Gently pull your penis away from your body to its full length. This should not be painful.

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Hold for 30 seconds

Hold the stretch for 30 seconds, then let go and allow your penis to return to its normal unstretched length.

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AT-HOME PENILE MODELING EXERCISE 2:
Penile straightening
1x PER DAY
30 SECONDS
Penis has a spontaneous erection

The second at-home penile modeling exercise is penile straightening. You should do the straightening exercise a maximum of once per day when you have a spontaneous erection. In other words, an erection that is not related to sexual activity.

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Hold your penis with one hand

Hold your penis with one hand.

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Bend in the opposite direction of the curve

With your other hand, gently try to bend the shaft of your erect penis in the opposite direction of the curve. Be careful not to bend so forcefully that you cause pain or discomfort.

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Hold for 30 seconds

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

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DAILY FOR 6 WEEKS
At-home penile modeling (stretching and straightening exercises)

  1. Penile Stretching
  2. Penile Straightening

Talk to your urology specialist if you're unsure of how to perform either penile modeling exercise.

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HERE ARE SOME WAYS TO HELP YOU FIT PENILE MODELING INTO YOUR DAILY ROUTINE

Here are some ways to help you fit penile modeling into your daily routine.

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Set a recurring reminder on your phone.

Set a recurring reminder on your phone.

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Block your calendar three times a day, so you can have privacy and won't be interrupted.

Block your calendar three times a day, so you can have privacy and won't be interrupted.

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Add penile modeling to an existing routine, like after your morning shower or before brushing your teeth at night.

Add penile modeling to an existing routine, like after your morning shower or before brushing your teeth at night.

No matter when you fit penile modeling into your day, it's important to be consistent. Do it at a time that's best for you—it's important to get the best possible results from your treatment with XIAFLEX.


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.


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.