What is XIAFLEX®?
It is not known if XIAFLEX is safe and effective in children under the age of 18.
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.
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:
- swollen face
- breathing trouble
- chest pain
- low blood pressure
- dizziness or fainting
The most common side effects with XIAFLEX for the treatment of Peyronie's disease include:
Please see full Prescribing Information, including Boxed Warning and Medication Guide.