In-office treatment

Treating Peyronie’s disease (PD) with XIAFLEX

There are 2 equally important parts of each treatment cycle

PART 1: In-office treatment

Administered by your Urology Specialist, injections of XIAFLEX work to gradually break down your plaque over 1 to 4 treatment cycles, with about 6 weeks between each cycle.

Visit 1: Your first injection of XIAFLEX
Visit 2: After 1–3 days, you receive a second injection of XIAFLEX
Visit 3: After 1–3 days, a member of your urology care team will perform in-office penile modeling (penile stretching and straightening exercises), where they will stretch and straighten your penis

PART 2: At-home exercises

For 6 weeks after each treatment cycle with XIAFLEX, you will take a few minutes each day for at-home penile modeling (penile stretching and straightening exercises).

up to 4 cycles

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Urology Specialist visit 1

First injection of XIAFLEX. Wait 1–3 days.

Urology Specialist visit 2

Second injection of XIAFLEX. Wait 1–3 days.

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Urology Specialist visit 3

Your Urology Specialist will stretch and straighten your penis.

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At home for 6 weeks*

You stretch and straighten your penis daily.

*For approximately 6 weeks after each treatment cycle.

Part 1 and Part 2 complete 1 of up to 4 treatment cycles.

When to avoid sex and sexual activity

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 a treatment cycle
Until the pain and swelling have gone away

Actor portrayal.

Your treatment continues after you leave the office.

Your doctor will show you how to perform gentle at-home penile exercises that work in combination with the injections to continue breaking down the plaque.

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

What to expect after each injection

Your penis may be wrapped with a dressing. Your Urology Specialist will tell you when to take the dressing off.

It’s common to see bruising and swelling and to 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.

Benefits of XIAFLEX

Discover how XIAFLEX may help reduce the bend.

Paying for XIAFLEX

Eligible patients may qualify for copay assistance.^†

By accepting this offer, you agree to report the value received under this offer to any health insurer or other third party paying for any part of the XIAFLEX prescription if you are required to do so by benefit terms, contract, or law.
This offer is not valid for prescriptions reimbursed in whole or in part by Medicare, Medicare Prescription Drug Benefit plans, Medicare Advantage, VA, Medicaid, or similar federal or state programs, or where otherwise prohibited by law.
By accepting this offer, you agree that Endo USA, Inc. or those working on its behalf may contact your doctor to verify information about treatment that is relevant to verifying your eligibility for this offer.
This offer is only valid for doses of XIAFLEX administered in the US.
This offer is valid for the out-of-pocket cost for the dose of XIAFLEX only. Offer is not valid for any other products or other out-of-pocket costs (for example, office visit charges, office visit copays, or injection/administration costs), even if those costs are associated with the administration of a dose of XIAFLEX.
This offer is valid only if you have not used this program within the last 30 days.
The selling, purchasing, trading, or counterfeiting of this offer is prohibited.
Endo USA, Inc. reserves the right to rescind, revoke, or amend this offer without notice.
By participating, you understand and agree to comply with the terms and conditions of this offer as set forth above.

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:

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.

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

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.

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.