Active Ingredient: Collagenase
Collagenase 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intralesional, 0.58 milligrams collagenase, once every 1 to 3 days, 2 doses in total, over the duration of 6 weeks. This step is repeated 4 times.
Collagenase must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and treatment of male urological diseases. Patients with penile curvature >90° were not included in the clinical studies. Treatment in this group can therefore not be recommended.
The recommended dose of collagenase is 0.58 mg per injection administered into a Peyronie’s plaque. If more than one plaque is present, only the plaque causing the curvature deformity should be injected.
A treatment course consists of a maximum of 4 treatment cycles. Each treatment cycle consists of two collagenase injections and one penile modelling procedure. The second collagenase injection is administered 1 to 3 days after the first injection. A penile modelling procedure is performed 1 to 3 days after the second injection of each treatment cycle. The interval between treatment cycles is approximately six weeks.
Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to collagenase injection when desired. In the pivotal clinical studies about 30% of the patients received penile block before injection.
The location of the target treatment area in the Peyronie’s plaque is identified at the point of maximum concavity (or focal point) in the erect penis state and marked with a surgical marker. Collagenase should be injected into the target plaque when the penis is in a flaccid state. The injection procedure is detailed in the package leaflet and the physician training material and must be followed.
Penile modelling helps relieve curvature deformity and straighten the penile shaft. At the follow-up visit 1 to 3 days after the second injection of each treatment cycle, the trained physician should perform a penile modelling procedure on the flaccid penis to stretch and elongate the treated plaque that collagenase has disrupted. Local anaesthesia may be applied before the modelling if desired. Wearing gloves the physician should grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site. Direct pressure on the injection site should be avoided. The target plaque is used as a fulcrum point with both hands, to firmly apply a steady pressure to elongate and stretch the plaque. The goal is to gradually create bending opposite to the patient’s penile curvature, with stretching to the point of moderate resistance. The penile pressure should be hold for 30 seconds, thereafter released with a resting period for 30 seconds before repeating the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
In addition to the in-office penile modelling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the physician determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.
The safety of more than one treatment course of collagenase for Peyronie’s disease is not known.
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