Do you have a curved erection?It could be Peyronie’s disease
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Ask your healthcare professional (HCP) about XIAFLEX®, the only FDA-approved, nonsurgical treatment option for men with Peyronie’s disease with a “plaque” that can be felt and a curve in their penis greater than 30 degrees at the start of therapy.
Peyronie’s (pronounced “Pay-ROH-neez”) disease is caused by a plaque under the skin of the penis that results in a bent, or curved penis when erect. A Peyronie’s plaque may result from injury to the penis and/or genetic factors; however, the exact cause of Peyronie’s disease is unknown.
Peyronie’s disease is unlikely to go away on its own, and may get worse over time. That’s why speaking to your HCP about it is so important.
XIAFLEX® is the only treatment approved by the FDA to help treat Peyronie’s disease in adult men who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.
Prescription XIAFLEX® is injected into the scar tissue or Peyronie’s plaque. XIAFLEX® works to help weaken and break down the plaque. This along with gentle stretching and straightening activities, can help to straighten the curve in the erect penis caused by Peyronie’s disease.
Men received either up to 4 treatment cycles of XIAFLEX® with penile modeling, or placebo injection with penile modeling*, and then were observed until 52 weeks.
The goal of 2 large clinical studies involving more than 500 patients was to:
In the first study, men who received XIAFLEX® and penile modeling had an average change in their erectile curvature from the beginning of the study to Week 52 of 35%, compared with 18% in men who had placebo injection and penile modeling alone.*
In the second study, men who received XIAFLEX® and penile modeling had an average change in their erectile curvature from the beginning of the study to Week 52 of 33%, compared with 22% in men who had placebo injection and penile modeling alone.*
Patients in the studies were asked to answer questions from the Bother section of the Peyronie’s Disease Questionnaire (PDQ) at the beginning and end (Week 52) of the studies. The Bother section score is a total score from answers related to the following:
In the first study, men who received XIAFLEX® and penile modeling had an average reduction in their Bother section scores of 37% from the beginning of the study to Week 52, compared with 22% in men who had placebo injection and penile modeling.*
In the second study, men who received XIAFLEX® and penile modeling had an average reduction in their Bother section scores of 35% from the beginning of the study to Week 52, compared with 18% in men who had placebo injection and penile modeling.*
*No medicine.
Do not receive XIAFLEX® if you:
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.
Symptoms of corporal rupture or other serious injury to your penis may include:
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.
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®:
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:
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.
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.
This product information is intended for U.S. residents only.
Rx Only
XIAFLEX® is a registered trademark of Endo International plc or one of its affiliates.
© 2018 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
XP-05494/September 2018 www.xiaflex.com 1-800-462-ENDO (3636)
The information in this website should not take the place of talking with your doctor or healthcare professional.
You are encouraged to report negative side effects of prescription drugs. Contact Endo Pharmaceuticals, at 1‑877‑663‑0412 or the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch.
WebMD does not endorse any specific product, service, or treatment.
Do not receive XIAFLEX® if you:
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.
Symptoms of corporal rupture or other serious injury to your penis may include:
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.
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®:
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:
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.
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.
This product information is intended for U.S. residents only.
Rx Only
XIAFLEX® is a registered trademark of Endo International plc or one of its affiliates.
© 2018 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
XP-05494/September 2018 www.xiaflex.com
1-800-462-ENDO (3636)
The information in this website should not take the place of talking with your doctor or healthcare professional.
You are encouraged to report negative side effects of prescription drugs. Contact Endo Pharmaceuticals, at 1‑877‑663‑0412 or the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch.
©2005-2018 WebMD LLC. All rights reserved.
WebMD does not provide medical advice, diagnosis or treatment. See additional information.
Do you have a curved erection?It could be Peyronie’s disease
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