NABOTA® (JEUVEAU®) 200u

Description

Name: NABOTA® (JEUVEAU®) 200u
Manufacturer: Daewoong Pharmaceutical Co. Ltd
Active Substance(s): BOTULINUM TOXIN TYPE A
Strength: 200u
Pack Size: 200u 1 vial
Accessories: 1 x 200 Units Vial

NABOTA® (JEUVEAU®) 200u is a highly purified form of botulinum toxin type A (prabotulinumtoxinA-xvfs), used for the temporary improvement of moderate to severe glabellar lines in adult patients. This product works by inhibiting acetylcholine release, thereby blocking nerve impulses and relaxing facial muscles that contribute to expression lines. JEUVEAU® is FDA-approved specifically for aesthetic use, offering a targeted solution with minimal systemic absorption and rapid cosmetic results.

• Targeted Aesthetic Application: FDA-approved exclusively for glabellar lines between the eyebrows.
• High Response Rates: In clinical trials, 67–71% of patients showed ≥2-grade improvement by Day 30.
• Minimized Systemic Risk: Engineered for local neuromuscular effect, with no detectable systemic circulation at recommended doses.

JEUVEAU® 200u is supplied as a vacuum-dried powder in two 100-unit single-use vials, intended for intramuscular injection after reconstitution. It is packaged in protective cartons to prevent light exposure and preserve product integrity.

Ingredients:

• Active Ingredient: PrabotulinumtoxinA-xvfs, 100 Units per vial
• Excipients:
  • Human serum albumin (0.5 mg)
  • Sodium chloride (0.9 mg)

The powder is preservative-free and must be reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, USP prior to injection.

NABOTA® (JEUVEAU®) 200u is indicated for the temporary improvement of moderate to severe glabellar lines in adults. It is not approved for other indications such as spasticity or migraine, and its use must be limited to its approved cosmetic purpose.

Indications:

• Glabellar lines caused by activity of corrugator and/or procerus muscles

Contraindications:

• Hypersensitivity to botulinum toxin or formulation components
• Active infection at the proposed injection site

Adverse Reactions:

Very Common (≥10%):

• Headache (12%)

Common (1–9%):

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

Severe/Reported Reactions:

• Swallowing and breathing difficulties
• Cardiovascular events (arrhythmia, myocardial infarction)
• Hypersensitivity reactions (anaphylaxis, urticaria)
• Systemic spread of toxin effects including diplopia, muscle weakness, and dysarthria

Administration of JEUVEAU® must be performed by trained healthcare professionals familiar with facial anatomy and safe injection techniques. It requires reconstitution prior to use and is injected into specific muscle sites to target frown lines.

Preparation and Injection:

• Reconstitution: Add 2.5 mL of preservative-free 0.9% Sodium Chloride to each 100 Unit vial
  Concentration Achieved: 4 Units per 0.1 mL
• Total Dose for Glabellar Lines: 20 Units, injected as:
  • 0.1 mL (4 Units) into each of 5 intramuscular sites:
    • Inferomedial and superior middle of each corrugator muscle (4 sites)
    • Midline of procerus muscle (1 site)

Precautionary Guidelines:

• Avoid injecting within 1 cm of the supraorbital ridge
• Do not inject too close to the central eyebrow
• Use 30–33 gauge needle for precision
• Monitor for signs of ptosis, especially in patients with strong brow depressor complexes

Storage Instructions:

• Store unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton
• Use within 24 hours of reconstitution
• Do not freeze after reconstitution
• Discard any unused solution after single patient use

Accurate technique, dosing, and adherence to safety protocols are essential to achieving effective, safe, and repeatable aesthetic results with NABOTA® (JEUVEAU®) 200u.

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.