Questions and answers to physicians
What is Xiapex?
Xiapex is the first EMA approved medicine for patients with Peyronie’s disease as an alternative to surgery or surgical procedures. Xiapex is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.1
How does Xiapex work?
The signs and symptoms of Peyronie’s disease are caused by a collagen plaque. Injection of Xiapex into a Peyronie’s plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie’s disease are reduced.
Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and thus reduces the contraction.1
How is Xiapex dosed?
The dose of Xiapex is 0,58 mg per injection administered into a Peyronie’s plaque. If more than one plaque is present, inject into the plaque causing the curvature deformity.
How is Xiapex stored?
Prior to reconstitution, the vials of lyophilized powder of Xiapex and sterile diluent should be stored in a refrigerator at 2°C to 8°C. Do not freeze.
What are the most common side effects?
Most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection. The adverse reaction profile was similar after each injection, regardless of the number of injections administered. The most frequently reported adverse drug reactions (>25%) during the Xiapex clinical studies (832 male patients, 551 patients received Xiapex) were penile haematoma, penile swelling and penile pain. Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.1
Why is the Xiapex training program needed?
The European Medicines Agency has required that Sobi shall ensure that all physicians who are expected to prescribe/use the product are appropriately trained in the correct administration of the product and experienced in the diagnosis and management of the disease. Sobi offers a comprehensive training program designed to ensure proficiency and to minimize any risks related to administration, such as corporal rupture.
Questions and answers to patients
How soon after treatment can I have sex again?
Do not have sex or have any other sexual activity for at least 2 weeks after the second injection in each treatment cycle with Xiapex and after any pain and swelling has gone away.
Other medicines and Xiapex?
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Xiapex with certain other medicines can cause serious side effects. Especially tell your doctor if you are taking medicines to help control the normal clotting of your blood (known as anti-coagulation medicine).
Can I drive and use machines?
If you experience dizziness, numbness, altered sensation or headaches immediately after an injection of Xiapex you must avoid potentially hazardous tasks such as driving or using machines until these effects have passed or until advised by your doctor.
When is Xiapex not recommended?
If you are you allergic to the active substance in Xiapex (collagenase clostridium histolyticum bacteria) or any of the other substances included in the product, do not undergo treatment with Xiapex. Also, Xiapex is not recommended when treatment of the plaque involves the tube (called the urethra) that your urine passes through. Talk to your doctor about your type of curvature and the suitability of treatment.
- Xiapex Summary of Product Characteristics.