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  • Xiapex
    / Megapharm


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    0.9 mg / 3 ml

    partial basket chart 28717 24089

    Related information


    Dosage

    Dupuytren’s contracture: This drug must be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and management of Dupuytren’s disease.
    Posology: The recommended dose is 0.58 mg per injection into a palpable Dupuytren’s cord. The volume of reconstituted drug to be administered into the Dupuytren’s cord differs depending on the type of joint being treated.
    For cords affecting MP joints each dose is administered in an injection volume of 0.25 ml.
    For cords affecting PIP joints, each dose is administered in an injection volume of 0.20 ml.
    Injections in up to two cords or two affected joints in the same hand can be administered according to the injection procedure during a treatment visit. Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit. Each injection contains a 0.58 mg dose. If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.
    Approximately 24-72 hours after injection, a finger extension procedure may be performed, as necessary. To facilitate cord disruption. If a satisfactory response has not been achieved, the injection and finger extension procedures may be repeated after approximately 4 weeks. Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals. Only one cord must be treated at a time. If the disease has resulted in multiple contractures, treatment of each cord must be undertaken in a sequential order, as determined by the physician. Clinical study experience with this drug is currently limited to up to 3 injections per cord and up to 8 injections in total.
    Injection procedure: For the reconstitution instructions Administration of a local anaesthetic medicinal product prior to injection of the drug into a Dupuytren’s cord is not recommended, as it may interfere with proper placement of the injection. The joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) should be confirmed and the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection). The injection procedure is detailed in the package leaflet and the physician training material and must be followed.
    Patients should be instructed: To return to see their physician approximately 24 – 72 hours after injection for an examination of the injected hand and a finger extension procedure to disrupt the cord. Not to flex or extend the fingers of the injected hand to reduce extravasation of the drug  out of the cord until the finger extension procedure is completed. Not to attempt to disrupt the injected cord by self-manipulation at any time. To elevate the injected hand as much as possible until the day after the finger extension procedure.
    Finger extension procedure: At the follow-up visit approximately 24 – 72
    hours after injection, it should be determined if the contracture has resolved. If a cord contracture remains, a passive finger extension procedure will be performed in an attempt to disrupt the cord. Local anaesthesia may be used, if needed, during the finger extension procedure. While the patient’s wrist is in the flexed position, a moderate stretching pressure should be applied to the injected cord by extending the finger for approximately 10 to 20 seconds. For cords affecting the PIP joint, the finger extension procedure should be performed when the MP joint is in the flexed position. If the first finger extension procedure does not result in disruption of the cord, a second and third attempt can be performed at 5- to 10-minute intervals. No more than 3 attempts per affected joint are recommended to disrupt a cord.
    If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection. If, at that subsequent visit the contracted cord persists, an additional injection and finger extension procedure may be performed. Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), the patients should be instructed to: Not perform strenuous activity with the injected hand until advised to do so. Wear the splint at bedtime for up to 4 months. Perform a series of finger flexion and extension exercises several times a day for several months.
    Peyronie’s disease: The drug must be administered by a physician appropriately trained in the correct administration of the 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.
    Posology: The recommended dose is 0.58 mg per injection administered into a Peyronie’s plaque. The volume of reconstituted drug to be administered into the plaque is 0.25 ml . 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 injections and one penile modeling procedure. The second injection is administered 1 to 3 days after the first injection. A penile modeling procedure is performed 1 to 3 days after the second injection of each treatment cycle. The interval between treatment cycles is approximately six weeks.
    Injection procedure: For The reconstitution instructions:  Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to 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. This drug 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 modeling procedure: Penile modeling 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 modeling procedure on the flaccid penis to stretch and elongate the treated plaque that the drug  has disrupted. Local anaesthesia may be applied before the modeling 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 modeling technique for a total of 3 modeling attempts at 30 seconds for each attempt. In addition to the in-office penile modeling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modeling activities at home each day for the 6-week period following the physician penile plaque modeling 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 this drug for Peyronie’s disease is not known.
    Special population: Elderly: Due to the lack of quantifiable systemic exposure of the drug in patients with Dupuytren’s contracture and minimal and short-lived systemic exposure of the drug in patients with Peyronie’s disease, no dose adjustment is necessary. No overall differences in safety or effectiveness were observed between elderly and younger patients.
    Hepatic impairment: Due to the lack of quantifiable systemic exposure of the drug in patients with Dupuytren’s contracture and minimal and short-lived systemic exposure of the drug in patients with Peyronie’s disease, no dose adjustment is necessary.
    Renal impairment: Due to the lack of quantifiable systemic exposure of the drug  in patients with Dupuytren’s contracture and minimal and short-lived systemic exposure of the drug in patients with Peyronie’s disease, no dose adjustment is necessary.
    Paediatric population: There is no relevant use of the drug in the paediatric population aged 0-18 years for the treatment of Dupuytren’s contracture. Peyronie’s disease occurs exclusively in adult male patients and hence there is no relevant use of the drug in the paediatric population aged 0-18 years for the treatment of Peyronie’s disease.
    Method of administration: The reconstituted drug solution is administered via intralesional injection.
    For volume of injection: See prescribing information for full details.  


    Indications

    Treatment of  Dupuytren’s contracture in adult patients with a palpable cord. 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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Treatment of Peyronie’s plaques  that involve the penile urethra due to potential risk to this structure.
    See prescribing information for full details.


    Special Precautions

    Allergic reactions: Following drug  injection, severe allergic reaction could occur, and patients should be observed for 30 minutes before leaving the clinic in order to monitor for any signs or symptoms of a serious allergic reaction, e.g. wide spread redness or rash, swelling, tightness in the throat or difficulty breathing. Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren’s contracture: This drug must only be injected into the Dupuytren’s cord. Corporal rupture (fracture of penis) or other serious injury to the penis in the treatment of Peyronie’s disease.
    Use in patients with coagulation disorders: The drug must be used with caution in patients with coagulation disorders or those taking anticoagulants.
    Immunogenicity: As with any non-human protein medicinal product, patients may develop antibodies to the therapeutic protein.
    Post-treatment surgery: The impact of treatment with this drug on subsequent surgery, if needed, is not known. Long-term safety in Peyronie’s disease is not fully characterized.
    See prescribing information for full details.


    Side Effects

    Very common: Lymphadenopathy, Pruritus, Ecchymosis, Pain in extremity, Oedema peripheral, Injection site haemorrhage, pain or swelling
    Tenderness, Contusion.
    Common: Lymph node pain, Paresthesia, Hypoesthesia, Burning sensation, Dizziness, Headache, Blood blister, Blister rash, Erythema,
    Hyperhidrosis, Arthralgia, Joint swelling, Myalgia, Axillary pain, Inflammation
    Injection site warmth, erythema, inflammation, vesicles or pruritus, Swelling, Skin laceration.
    See prescribing information for full details.


    Drug interactions

    No formal medicinal product interaction studies with this drug have been performed. There is no quantifiable systemic exposure following a single injection of Xiapex in patients with Dupuytren’s contracture and only minimal and short-lived systemic exposure of Xiapex in patients with Peyronie’s disease.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: No clinical data on exposed pregnancies are available.
    Lactation: It is not known whether collagenase clostridium histolyticum is excreted in human milk.
    See prescribing information for full details.                


    Overdose

    Administration of this drug at greater than recommended doses is expected to be associated with increased local reactions at the site of injection. Routine supportive care and symptomatic treatment must be provided in the case of overdose.  


    Important notes

    Storage: Store in a refrigerator (2ºC-8ºC), do not freeze.
    Effects on ability to drive and use machines: This drug may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren’s disease.
    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except the solvent for solution for injection for reconstitution.

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