BOTULAX® (LETYBO®) 200u (Korean)

BOTULAX® 200u is a botulinum toxin type A injectable product developed by Hugel Inc. for both aesthetic and therapeutic applications. It is derived from Clostridium botulinum strain CBFC26 and acts by inhibiting acetylcholine release at the neuromuscular junction, resulting in targeted and temporary muscle paralysis. BOTULAX® is indicated for the treatment of benign essential blepharospasm and is widely used off-label for cosmetic indications such as dynamic facial lines. The product has been clinically validated through Phase III studies demonstrating non-inferiority to Botox® in efficacy and duration.

BOTULAX® 200u is manufactured in accordance with KFDA standards and features a vacuum-dried powder formulation requiring reconstitution prior to use. The effects typically begin within 3–5 days, peak at 1–2 weeks, and last for up to 3–4 months.

BOTULAX® 200u should be reconstituted with preservative-free 0.9% sodium chloride and administered intramuscularly by trained professionals.

Key Features:

• Initial onset: 3–5 days post-injection
  
• Peak effect: 1–2 weeks
  
• Duration: 3–4 months
  

Protocol Guidelines:

• Use 27–30 gauge needle
  
• Reconstitute to appropriate concentration based on injection volume
  
• Recommended dose for blepharospasm: 12.5–25 Units per eye (0.05–0.1 mL per injection site)
  
• Cumulative dose limit: Do not exceed 200 Units within a 30-day period
  
• Use within 24 hours after reconstitution
  
• Store reconstituted solution at 2–8°C
  

Indication:

• Treatment of benign essential blepharospasm in patients aged 18 and older
  

Contraindications:

• Hypersensitivity to any component of the formulation
  
• Neuromuscular disorders (e.g., myasthenia gravis, ALS)
  
• Pregnancy or breastfeeding
  
• Infection at the proposed injection site
  

Side Effects (Blepharospasm Patients):

• Ptosis (6.5%)
  
• Lagophthalmos (5.6%)
  
• Dry eye (5.6%)
  
• Photophobia (4.1%)
  
• Myasthenia (1.6%)
  
• Chills, headache, dizziness, fatigue, muscle pain, and injection site reactions
  

Each vial contains:

• Clostridium botulinum toxin type A (strain CBFC26): 200 Units
  
• Human serum albumin: 1.0 mg
  
• Sodium chloride: 0.9 mg
  

Supplied as a sterile, freeze-dried white powder.

Packaging Details:

• One single-use vial containing 200 Units of vacuum-dried powder
  
• Vial made of colorless transparent glass
  
• For intramuscular injection only after reconstitution
  
• Does not contain preservatives
  

Yes, both local and systemic side effects have been reported.

Common Side Effects:

• Injection site reactions: pain, swelling, redness, bruising
  
• Facial muscle weakness
  
• Dry eye, ptosis, myalgia
  
• Chills, dizziness, fatigue
  

Serious Adverse Events (rare):

• Dysphagia, aspiration pneumonia
  
• Respiratory compromise
  
• Anaphylaxis, urticaria, and angioedema

Storage Instructions:

• Store unopened vials at 2–8°C
  
• After reconstitution, use within 24 hours
  
• Keep refrigerated (2–8°C)
  
• Do not freeze
  
• Protect from light and contamination