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    brand:

    NABOTA® (JEUVEAU®)

    manufacturer:

    Daewoong Pharmaceutical Co. Ltd

    active substances:

    BOTULINUM TOXIN TYPE A

    strength:

    200u

    pack size:

    1 x 200 Units Vial

    INFORMATION

    NABOTA® (JEUVEAU® Indications for Use

    NABOTA® (JEUVEAU®) (prabotulinumtoxinA-xvfs) is a prescription medication indicated for the temporary improvement in the appearance of moderate to severe glabellar lines. These lines, often referred to as “frown lines,” are associated with corrugator and procerus muscle activity in adults. It works as a neuromuscular blocking agent that inhibits the release of acetylcholine, a neurotransmitter responsible for muscle contraction.

    • Target patients: Adults with moderate to severe glabellar lines.
    • Mechanism of action: Inhibition of acetylcholine release at neuromuscular junctions, reducing muscle activity.

    NABOTA® (JEUVEAU® Dosage Information

    The recommended dosage for NABOTA® (JEUVEAU®) is a total of 20 Units injected across five intramuscular sites, focusing on the muscles responsible for frown lines (corrugator and procerus muscles).

    • Administration:
      • 0.1 mL (4 Units) injected into each of the five designated sites.
      • The injection sites include the inferomedial and superior middle areas of each corrugator muscle and one site in the middle of the procerus muscle.
    • Reconstitution: Reconstitute each vial with 2.5 mL of preservative-free saline, resulting in a 4 Units/0.1 mL concentration.
    • Storage: Use within 24 hours of reconstitution and store between 2°C and 8°C (36°F to 46°F).

    NABOTA® (JEUVEAU® Side Effects and Precautions

    NABOTA® (JEUVEAU®) carries several risks associated with the spread of botulinum toxin effects beyond the injection site, which can result in life-threatening symptoms. These include breathing difficulties, swallowing issues, and, in rare cases, death.

    Common side effects (≥1% occurrence):

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

    Serious side effects:

    Distant spread of toxin effects leading to generalized muscle weakness, difficulty swallowing, speech disorders, and breathing difficulties. These symptoms can appear hours to weeks after injection and may be life-threatening in severe cases.

    • Cardiovascular risks: Reports of arrhythmia and myocardial infarction, some fatal, especially in patients with pre-existing heart conditions.
    • Neuromuscular disorders: Patients with conditions like amyotrophic lateral sclerosis (ALS) or myasthenia gravis are at greater risk for serious side effects like severe muscle weakness and respiratory compromise.
    • Ophthalmic complications: Dry eye and corneal disorders due to reduced blinking or tear production.

    Precautions include avoiding use in patients with hypersensitivity to botulinum toxins or those with infections at the injection site. The product is not interchangeable with other botulinum toxin products due to differences in biological activity.

    NABOTA® (JEUVEAU® Clinical Studies and Real-World Outcomes

    Clinical trials demonstrated the efficacy of NABOTA® (JEUVEAU®) in improving the appearance of glabellar lines in adults, with two randomized, placebo-controlled studies (EV-001 and EV-002) involving a total of 654 subjects. Both studies measured the improvement of glabellar lines on a 4-point Glabellar Line Severity Scale (GLS), with results indicating substantial efficacy:

    • Primary results (30-day assessment):
      • Trial EV-001: 67% of patients treated with NABOTA® (JEUVEAU®) showed a ≥2-grade improvement in glabellar lines, compared to 1% in the placebo group.
      • Trial EV-002: 71% of NABOTA® (JEUVEAU®)-treated patients demonstrated a ≥2-grade improvement, versus 1% in the placebo group.

    The product was well-tolerated, and adverse events were consistent with those seen in other botulinum toxin products. The most common side effects were mild and typically resolved within weeks of treatment.

    NABOTA® (JEUVEAU® Drug Interactions

    Use of NABOTA® (JEUVEAU®) may be potentiated by certain medications, including:

    • Aminoglycosides or other agents that interfere with neuromuscular transmission.
    • Muscle relaxants.
    • Anticholinergic drugs.
    • Other botulinum neurotoxins.

    Patients should be carefully monitored if they are taking any of these medications, as the effects of NABOTA® (JEUVEAU®) may be amplified, increasing the risk of complications like excessive muscle weakness.

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