LETYBO® 50u (English)

Letybo® 50u is a prescription medicine containing botulinum toxin type A presented as a sterile powder for solution for injection. It works by blocking nerve impulses to injected muscles, temporarily reducing muscle contraction and smoothing targeted facial lines.

• Active substance: botulinum toxin type A
• Vial strength: 50 units per vial
• Mechanism: blocks neuromuscular transmission → temporary reduction in muscle activity
• Target use (licensed): temporary improvement of moderate to severe vertical glabellar lines (between eyebrows) in eligible adults

Letybo® 50u must be administered only by an appropriately qualified healthcare professional using correct equipment and aseptic technique. The labeled regimen for glabellar lines uses a total 20 units delivered as 5 intramuscular injections.

• Route: intramuscular (IM)
• Recommended total dose: 20 units
• Injection pattern: 5 injections × 1 mL each = 4 units per injection
• Minimum retreatment interval: ≥3 months between sessions
• Diluent for reconstitution: 9% sodium chloride (9 mg/mL)
• Reconstitution volume: add 25 mL diluent to the vial
• Concentration after reconstitution: 1 mL = 4 units
• Needle/syringe (for IM injection): 1 mL insulin/tuberculin syringe with 01 mL graduations; 30–31G needle
• Single-use session: vial is used for one session per patient; unused solution is discarded

Letybo® 50u is indicated in adults to temporarily improve moderate to severe vertical lines between the eyebrows (glabellar lines) when these lines have a significant psychological impact. It is not recommended for children/adolescents and should not be used in certain neuromuscular conditions or when injection sites are infected/inflamed.

• Indication (licensed): adults <75 years for moderate to severe glabellar lines with significant psychological impact
• Contraindications (do not use):
  • Hypersensitivity to botulinum toxin type A or excipients
  • Neuromuscular disorders: myasthenia gravis, Lambert–Eaton syndrome, amyotrophic lateral sclerosis (ALS)
  • Acute infection or inflammation at proposed injection sites
• Not recommended:
  • <18 years
  • Pregnancy or breast-feeding, or if of childbearing potential not using contraception
• Important warnings (rare but serious): toxin spread may cause swallowing, speech, or breathing difficulties; seek urgent medical help if these occur

Letybo® 50u contains botulinum toxin type A as the active ingredient and includes stabilizing excipients typical for botulinum toxin products. It is essentially sodium-free per dose.

• Active ingredient: botulinum toxin type A (produced by Clostridium botulinum)
• Strength: 50 units per vial
• After reconstitution: 1 mL contains 4 units
• Excipients: human albumin, sodium chloride
• Sodium content: <1 mmol (23 mg) sodium per dose (essentially “sodium-free”)

Letybo® 50u should be kept refrigerated and used according to expiry and stability guidance. Once reconstituted, stability is limited and unused solution should not be kept beyond the recommended window.

• Storage (unreconstituted): refrigerate 2°C–8°C (store and transport)
• Expiry: do not use after EXP (last day of the stated month)
• Reconstituted solution stability: 24 hours at 2–8°C (chemical/physical stability demonstrated)
• Microbiological guidance: ideally use immediately after reconstitution unless aseptic handling controls contamination risk; storage conditions become the user’s responsibility
• Discard rule: any reconstituted solution stored >24 hours must be discarded
• Safety: keep out of sight and reach of children

Side effects are possible, and most are mild to moderate, typically appearing within the first few days after injection and being temporary. Rarely, serious reactions can occur, including symptoms consistent with toxin spread (e.g., difficulty swallowing or breathing), which require urgent medical attention.

• Common (≤1 in 10): headache, injection site reactions
• Uncommon (≤1 in 100):
  
  • drooping of the upper eyelid, eyelid spasm
  • head discomfort
  • local swelling (e.g., eyelid/face/around eyes)
  • injection site: pain, bruising, swelling, itching, mass, pressure
  • bruising around eyes, upper respiratory viral infection (common cold)
  • Mephisto sign (raising of the outer eyebrows)
• Rare (≤1 in 1,000):
  
  • eyelid sensory disorder, drooping of brow, bleeding in conjunctiva
  • eye pain, dry eye, visual field defect, blurred vision
  • reduced throat sensation, constipation, speech sound disorder
  • migraine, dizziness, abnormal sensations (tingling/itching), nausea
  • rash/itching, facial pain, fever, oral herpes, influenza-like illness
  • increased blood potassium
• Very rare (≤1 in 10,000): muscle weakness, difficulty swallowing, difficulty breathing, aspiration-related infection
• Severe allergy (potentially serious): swelling of face/lips/mouth/throat with difficulty swallowing/breathing/speaking, possibly with hives

Letybo® 50u is supplied as a white powder in a clear glass vial sealed for medicinal use. Pack configurations may vary by market and can include single packs or multipacks.

• Dosage form: white powder for solution for injection
• Container: clear glass vial with rubber stopper and aluminium tamper-proof seal
• Pack sizes:
  • Single pack: 1 vial or 2 vials
  • Multipack: 2 cartons (each carton contains 1 vial)
  • Multipack: 6 cartons (each carton contains 1 vial)
• Note: “Not all pack sizes may be marketed.”