DYSPORT® 300u

DYSPORT® 300u (abobotulinumtoxinA) Product Information

DYSPORT® 300u is a botulinum toxin type A injectable product designed for both therapeutic and cosmetic applications. It helps manage neuromuscular conditions like cervical dystonia and spasticity and offers temporary improvement in the appearance of wrinkles such as glabellar lines. The product is supplied in a sterile, single-use vial for intramuscular injection.

Key Features and Benefits of DYSPORT® 300u

DYSPORT® 300u provides targeted neuromuscular relaxation, offering various benefits:

• Versatile Usage: Approved for medical and cosmetic treatments.
• Extended Efficacy: Results last 12–16 weeks for therapeutic uses and up to 4 months for glabellar lines.
• High Purity and Precision: Contains abobotulinumtoxinA in a stable formulation.
• Customizable Dosing: Allows tailoring to individual treatment needs.

Reconstitution Chart for DYSPORT® 300u

Proper reconstitution ensures optimal efficacy and safety:

• Diluent: Use sterile preservative-free 0.9% Sodium Chloride Injection, USP.
• Dilution Guide:
  • 0.6 mL: 50 units per 0.1 mL.
  • 1.5 mL: 20 units per 0.1 mL.
  • 2.5 mL: 12 units per 0.1 mL.

Handling Instructions:

• Gently swirl to mix (do not shake).
• Inspect the solution for clarity; it should be clear and colorless.
• Use reconstituted products within 24 hours and store at 2–8°C. Do not freeze.

Storage Information for DYSPORT® 300u

• Store the lyophilized product at 2–8°C in its original packaging.
• After reconstitution:
  • Keep refrigerated at 2–8°C and protect from light.
  • Use within 24 hours to maintain potency.
  • Discard unused portions responsibly.

Treatment Areas for DYSPORT® 300u

DYSPORT® 300u targets specific muscles based on the therapeutic or cosmetic goal:

• Therapeutic Uses:
  • Cervical Dystonia: Injected into neck and shoulder muscles to reduce spasticity.
  • Upper Limb Spasticity: Affects flexors of the elbow, wrist, and fingers.
  • Lower Limb Spasticity in Pediatric Patients: For conditions like cerebral palsy.
• Cosmetic Use:
  • Glabellar Lines: Injected into the corrugator and procerus muscles to smooth frown lines.

Each injection requires careful placement based on the anatomy of the treatment area.

Dosing for Different Indications of DYSPORT® 300u

Dosing is tailored to the indication and patient-specific factors:

• Cervical Dystonia:
  • Initial dose: 500 units divided across affected muscles.
  • Maintenance: Re-treat every 12–16 weeks, adjusting doses in 250-unit increments.
• Glabellar Lines:
  • Total dose: 50 units divided into five equal injections (10 units each).
  • Interval: Re-treat every 3 months as needed.
• Upper Limb Spasticity:
  • Dose: 500–1000 units per treatment session.
  • Re-treatment every 12 weeks.
• Lower Limb Spasticity in Pediatric Patients:
  • Dose: 10–15 units/kg per limb, not exceeding 30 units/kg or 1000 units per session.

Side Effects and Precautions for DYSPORT® 300u

Common Side Effects

• Cervical Dystonia:
  • Dysphagia (15%), muscular weakness (16%), dry mouth (13%).
• Glabellar Lines:
  • Headache, injection site discomfort, eyelid ptosis (≤2%).
• Spasticity:
  • Muscular weakness, fatigue, pain in extremities, and injection site reactions.

Precautions

• Contraindications:
  • Allergy to botulinum toxin or cow’s milk protein.
  • Infection at the injection site.
• Warnings:
  • Spread of toxin effects may cause dysphagia, breathing difficulties, or generalized weakness.
  • Patients with neuromuscular disorders require close monitoring.
  • Do not exceed recommended doses or frequency of administration.

Aftercare Following DYSPORT® 300u Treatment

Adhering to aftercare recommendations minimizes side effects and optimizes results:

• Avoid manipulating the treatment area for at least 4 hours post-injection.
• Refrain from strenuous activities and heat exposure for 24 hours.
• Use sunscreen if the treated area is exposed to sunlight.
• Monitor for adverse reactions and report concerns to a healthcare provider.

Drug Interactions with DYSPORT® 300u

• Neuromuscular Blockers: May potentiate effects; monitor closely.
• Anticholinergic Drugs: Can increase systemic anticholinergic effects, like blurred vision or dry mouth.
• Other Botulinum Toxin Products: Avoid concurrent use to prevent excessive muscle weakness.