NABOTA® (JEUVEAU®) 100u

Description

Name: NABOTA® (JEUVEAU®) 100u
Manufacturer: Daewoong Pharmaceutical Co. Ltd
Active Substance(s): BOTULINUM TOXIN TYPE A
Strength: 100u
Pack Size: 100u 1 v ial
Accessories: 1 x 100 Units Vial

NABOTA® (JEUVEAU®) 100u is an injectable formulation of prabotulinumtoxinA-xvfs, a botulinum toxin type A derived from Clostridium botulinum. It is indicated for the temporary improvement of moderate to severe glabellar lines (frown lines) in adults. This product functions as a neuromuscular blocking agent, inhibiting the release of acetylcholine at the neuromuscular junction, thus reducing muscle activity responsible for dynamic facial wrinkles.

• FDA-approved for Aesthetic Use: Specifically indicated for glabellar lines, unlike other botulinum toxins with broader indications.
• High Efficacy: Clinical trials showed 67–71% response rate in reducing frown line severity after a single 20-unit dose.
• Rapid Onset and Long-Lasting: Visible improvements typically appear within days and may last for several months.

NABOTA® is supplied as a sterile, vacuum-dried powder in a single-dose 100 Unit vial for intramuscular injection after reconstitution. The vial is presented in a sealed carton to protect from light and preserve potency.

Composition:

• Active Ingredient: 100 Units of prabotulinumtoxinA-xvfs (Botulinum toxin type A complex)
• Excipients:
  • Human serum albumin (0.5 mg)
  • Sodium chloride (0.9 mg)

This preservative-free formulation must be reconstituted with 0.9% Sodium Chloride Injection, USP before administration.

JEUVEAU is approved solely for the temporary aesthetic treatment of moderate to severe glabellar lines. It is not approved for therapeutic uses like spasticity or cervical dystonia.

Indications:

• Adults with glabellar lines caused by corrugator and/or procerus muscle activity

Contraindications:

• Hypersensitivity to botulinum toxin or excipients
• Infection at the proposed injection site

Adverse Reactions:

Very Common (≥10%):

• Headache (up to 12%)

Common (1–9%):

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

Less Common but Serious:

• Dysphagia, aspiration, and respiratory distress
• Cardiovascular events, including arrhythmias and myocardial infarction
• Systemic spread of toxin may lead to generalized muscle weakness, vision changes, or loss of bladder control

Patients with pre-existing neuromuscular conditions, breathing difficulties, or allergies to botulinum products are at elevated risk.

Proper administration requires understanding of facial anatomy and reconstitution protocol. Only trained medical professionals should perform the injection.

Administration Technique:

• Reconstitution: Add 2.5 mL of preservative-free 0.9% Sodium Chloride Injection to yield a 4 Units per 0.1 mL solution.
• Injection Sites:
  • Five intramuscular sites (two in each corrugator and one in the procerus muscle)
  • Dose per site: 4 Units (0.1 mL); Total dose: 20 Units
• Needle: Use a 30–33 gauge needle for administration.

Safety Tips:

• Avoid injections near levator palpebrae superioris to minimize eyelid drooping
• Place lateral injections ≥1 cm above supraorbital ridge
• Do not exceed recommended dose or frequency (no more than every 3 months)

Storage Instructions:

• Unopened vials: Store in refrigerator (2–8°C / 36–46°F) in original carton.
• After reconstitution: Store up to 24 hours at 2–8°C, do not freeze.
• Single-use vial: Discard any remaining solution post-injection.

Strict adherence to dilution and storage protocols is essential to ensure safety, potency, and clinical effectiveness of the treatment.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.