Prime Time, A Branded Peyronie's Disease Commercial For XIAFLEX® (Collagenase Clostridium Histolyticum)
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. 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:
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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.
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Click for full Prescribing Information , including BOXED WARNING and Medication Guide .
About Endo
Endo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn .
Cautionary Statements Related To Forward-Looking Statements
This release contains forward-looking statements, including with regard to XIAFLEX the potential of this product to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with XIAFLEX; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's and Endo's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
* Most eligible patients with commercial insurance plans should pay a $0 copay for XIAFLEX. Predictions based on historical analysis of claims filed September 2022 through August 2023.
References
Hellstrom WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, et al. Adv Urol. 2011:282503.###
SOURCE Endo USA, Inc.
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