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    XEOMIN® 100u (English/Korean)  distributors
    XEOMIN® 100u (English/Korean)  distributors

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    brand:

    XEOMIN®

    manufacturer:

    Merz Pharma

    active substances:

    BOTULINUM TOXIN TYPE A

    strength:

    100u

    pack size:

    1 x 100 Units Vial

    INFORMATION

    XEOMIN® 100u (English/Korean) Indications for Use

    XEOMIN® (incobotulinumtoxinA) is a neuromuscular blocking agent used for the following therapeutic and aesthetic treatments:

    • Upper Limb Spasticity: Used in adult patients to reduce muscle tightness in the upper limbs (e.g., clenched fist, flexed wrist, or elbow).
    • Cervical Dystonia: To treat adults with abnormal neck position and pain associated with cervical dystonia.
    • Blepharospasm: For treating involuntary blinking (spasm of the eyelids) in adults previously treated with onabotulinumtoxinA (Botox®).
    • Glabellar Lines: Temporary improvement of moderate to severe frown lines between the eyebrows.

    XEOMIN blocks the release of acetylcholine, a chemical messenger that signals muscle contraction, resulting in reduced muscle activity.

    XEOMIN® 100u (English/Korean) Dosage Information

    The dosage of XEOMIN® varies depending on the condition being treated, the muscle size, and patient response to previous treatments. It is injected directly into the affected muscle groups, and dosing should be tailored to each patient’s needs.

    • Upper Limb Spasticity: The recommended dose is up to 400 units, administered no more than once every 12 weeks.
      • Flexor digitorum: 25-100 units per muscle.
      • Brachioradialis: 25-100 units.
      • Flexor carpi radialis: 25-100 units.
    • Cervical Dystonia: Initial recommended dose is 120 units. Injection is typically into muscles such as the sternocleidomastoid, levator scapulae, and trapezius.
    • Blepharospasm: Patients previously treated with onabotulinumtoxinA should receive a similar dose. Typical dose is 10-50 units per eye with up to 70 units total in both eyes.
    • Glabellar Lines: The standard dose is 20 units, administered across five injection sites in the glabellar region. Repeat treatment should occur no more frequently than every 3 months.

    Reconstitution: XEOMIN should be diluted with preservative-free 0.9% sodium chloride and used within 24 hours. The solution should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).

    XEOMIN® (incobotulinumtoxinA) Side Effects and Precautions

    XEOMIN® is generally well tolerated, but it can cause both common and serious side effects.

    • Common side effects:
      • Upper Limb Spasticity: Dry mouth, nasopharyngitis, seizure, and upper respiratory tract infection.
      • Cervical Dystonia: Dysphagia (difficulty swallowing), neck pain, muscle weakness, and pain at the injection site.
      • Blepharospasm: Ptosis (drooping eyelid), dry eye, visual impairment, and dry mouth.
      • Glabellar Lines: Headache, facial paresis (temporary facial weakness), and eyelid swelling.
    • Serious side effects:
      • Spread of toxin effect: XEOMIN, like other botulinum toxin products, may spread beyond the injection site, causing symptoms like muscle weakness, dysphagia, breathing difficulties, or even death.
      • Allergic reactions: Patients may experience serious hypersensitivity reactions such as anaphylaxis, urticaria, or difficulty breathing.
      • Dysphagia: Especially for cervical dystonia patients, the toxin may affect swallowing, requiring medical attention. In severe cases, dysphagia may result in aspiration pneumonia.

    Precautions:

    • XEOMIN should not be used in patients with a known hypersensitivity to botulinum toxin type A or infection at the injection site.
    • Avoid use in pregnant or breastfeeding women unless absolutely necessary, as the effects on fetal development or infant safety are unknown.
    • Patients with respiratory or neuromuscular disorders (e.g., ALS, myasthenia gravis) should use XEOMIN cautiously, as they are more prone to experiencing severe side effects like breathing difficulties.

    XEOMIN® (incobotulinumtoxinA) Clinical Studies and Real-World Outcomes

    Clinical trials have shown XEOMIN® to be effective in reducing symptoms of upper limb spasticity, cervical dystonia, blepharospasm, and glabellar lines.

    • Upper Limb Spasticity: In Phase 3 studies, patients treated with XEOMIN experienced significant improvements in muscle tone and spasticity, especially in areas such as the flexed elbow and wrist. Improvements were maintained for 12-14 weeks.
    • Cervical Dystonia: In a placebo-controlled trial, XEOMIN demonstrated a reduction in symptoms and improvement in neck muscle positioning for up to 12 weeks post-injection.
    • Blepharospasm: Patients previously treated with Botox showed comparable results with XEOMIN, with reductions in blinking spasms lasting for up to 12 weeks.
    • Glabellar Lines: In cosmetic studies, XEOMIN achieved a marked reduction in frown lines at 30 days post-injection, with effects lasting up to 120 days in some patients.

    XEOMIN® (incobotulinumtoxinA) Drug Interactions

    XEOMIN can interact with other medications that affect neuromuscular transmission or muscle relaxants.

    • Aminoglycoside antibiotics: These drugs may increase the effect of XEOMIN and lead to excessive muscle weakness.
    • Anticholinergics: May enhance systemic anticholinergic effects when used with XEOMIN.
    • Other botulinum toxin products: Using different types of botulinum toxins together or in sequence can lead to excessive weakness or side effects. Patients should not be treated with multiple toxins without a proper interval.

    XEOMIN® (incobotulinumtoxinA) Instructions for Use

    • Reconstitution: Reconstitute XEOMIN using sterile, preservative-free saline and administer within 24 hours.
    • Administration: Ensure proper technique and injection site selection to avoid unintended spread or complications.
    • Storage: Unopened vials can be stored at room temperature (20-25°C), refrigerated, or frozen. Once reconstituted, XEOMIN must be kept refrigerated and used within 24 hours.

    XEOMIN® (incobotulinumtoxinA) Contraindications and Warnings

    XEOMIN is contraindicated in:

    • Patients with a known allergy to botulinum toxin or any excipients (such as human albumin or sucrose).
    • Infection at the injection site.
    • Use in children or patients under 18 years is not recommended, as safety has not been established.

    Patients must be monitored closely for signs of toxin spread, including difficulty swallowing, speaking, or breathing. Immediate medical attention should be sought if these symptoms occur.

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