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    NABOTA® (JEUVEAU®) 100u  distributors

    Buy NABOTA® (JEUVEAU®) 100u Online

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    brand:

    NABOTA® (JEUVEAU®)

    manufacturer:

    Daewoong Pharmaceutical Co. Ltd

    active substances:

    BOTULINUM TOXIN TYPE A

    strength:

    100u

    pack size:

    1 x 100 Units Vial

    INFORMATION

    NAVOTA® (JEUVEAU®) Indications for Use

    NAVOTA® (JEUVEAU®) (prabotulinumtoxinA-xvfs) is a neuromuscular blocking agent, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults. Glabellar lines are the vertical lines between the eyebrows, often caused by the activity of the corrugator and procerus muscles.

    Key Indications:

    • Temporary reduction of moderate to severe glabellar lines
    • Adults seeking non-invasive aesthetic procedures for facial rejuvenation

    NAVOTA® (JEUVEAU®) Dosage Information

    NAVOTA® (JEUVEAU®) is supplied as a 100-unit vacuum-dried powder for intramuscular injection. Before administration, it must be reconstituted with preservative-free 0.9% sodium chloride. The recommended dose for glabellar lines is 20 units, administered as 0.1 mL (4 units) per injection at five different sites.

    Dosage Summary:

    • Diluent: 0.9% sodium chloride (preservative-free)
    • Reconstituted concentration: 4 units/0.1 mL
    • Total treatment dose: 20 units
    • Injection sites: Five (two per corrugator muscle and one in the procerus muscle)

    The treatment should not be repeated more than every three months to minimize potential side effects.

    NAVOTA® (JEUVEAU®)  Side Effects and Precautions

    NAVOTA® (JEUVEAU®) has been associated with both mild and severe side effects, some of which may be life-threatening. The most common side effects are headache and eyelid ptosis (drooping). Severe reactions, although rare, can include breathing difficulties and swallowing problems, which may occur due to the spread of botulinum toxin beyond the injection site.

    Common Side Effects:

    • Headache (9.3%)
    • Eyelid ptosis (2%)
    • Upper respiratory infection (3%)
    • Increased white blood cell count (1%)

    Serious Side Effects:

    • Distant spread of toxin: Symptoms such as difficulty swallowing, speaking, and breathing may arise, and in severe cases, death has been reported.
    • Allergic reactions: Symptoms such as rash, wheezing, or trouble breathing can indicate hypersensitivity.
    • Cardiovascular events: Arrhythmias and myocardial infarction, some with fatal outcomes, have been reported following botulinum toxin administration.

    Precautions:

    • Botulinum toxin spread: The effects of botulinum toxin can spread beyond the injection site, leading to generalized muscle weakness, diplopia, and blurred vision.
    • Dysphagia and breathing difficulties: Patients with a history of swallowing or respiratory disorders should be monitored closely, as they are at a higher risk for severe complications.
    • Contraindications: Hypersensitivity to any botulinum toxin products or infection at the injection site precludes use.

    NAVOTA® (JEUVEAU®)  Clinical Studies or Real-World Outcomes

    Two pivotal randomized, multi-center, placebo-controlled trials (EV-001 and EV-002) evaluated the safety and efficacy of NAVOTA® (JEUVEAU®) in treating moderate to severe glabellar lines. These trials included 654 adults aged 18 to 81, with most participants being female.

    Efficacy Data:

    • 67-71% of subjects experienced at least a 2-grade improvement from baseline in glabellar line severity at 30 days post-treatment, as assessed by both the investigator and the patient.
    • The placebo group showed 1% improvement, indicating significant efficacy for the treatment of glabellar lines.

    Adverse Events: In both trials, adverse events occurred within the first week post-injection and were generally mild, resolving within a few weeks. The most commonly reported adverse events were headache and eyelid ptosis.

    NAVOTA® (JEUVEAU®)  Drug Interactions

    NAVOTA® (JEUVEAU®) has not been extensively studied in drug interaction trials, but the potential for interactions with medications affecting neuromuscular transmission should be considered. Certain medications, such as aminoglycosides and muscle relaxants, may increase the risk of adverse effects when used with NAVOTA® (JEUVEAU®).

    Key Drug Interactions:

    • Aminoglycosides: May enhance neuromuscular blockade, leading to an increased risk of side effects like muscle weakness.
    • Muscle relaxants: Should be used cautiously, as they may potentiate the effects of NAVOTA® (JEUVEAU®).
    • Other botulinum toxins: Combining different botulinum toxin products could lead to cumulative dosing and an increased risk of toxin spread.

    NAVOTA® (JEUVEAU®)  Aftercare Instructions

    Patients receiving NAVOTA® (JEUVEAU®) should follow post-treatment care guidelines to ensure optimal outcomes and minimize complications.

    Post-Treatment Guidelines:

    • Avoid rubbing or massaging the treated area for at least 24 hours to prevent the spread of the toxin.
    • Patients should refrain from strenuous activity, alcohol consumption, and exposure to heat (e.g., saunas) for at least 48 hours after the injection.
    • Contact lenses should be removed before treatment and not reinserted for at least 15 minutes post-injection.

    What to Expect:

    • Bruising and swelling at the injection sites may last for a few days post-treatment.
    • Eyelid drooping is a known side effect but usually resolves within a few weeks.
    • Full treatment effects may take up to 30 days to appear, and results typically last for 3-4 months.

    Follow-Up Treatments

    Patients who are satisfied with the results of NAVOTA® (JEUVEAU®) may consider follow-up treatments every three to four months to maintain the desired appearance. Overuse should be avoided to minimize the risk of antibody development or toxin resistance.

    Recommended Schedule:

    • Treatments should not be repeated more than once every three months.
    • The cumulative dose from other botulinum toxin treatments should be considered to avoid exceeding the recommended dose.

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