What is the proper method to reconstitute Dysport (abobotulinumtoxinA)?

Dysport Reconstitution

Dysport must be reconstituted with preservative-free 0.9% Sodium Chloride Injection, USP using aseptic technique, with the specific volume depending on your desired final concentration. 1

Reconstitution Procedure

Step-by-Step Instructions

Draw up the diluent:

• Use an appropriately sized sterile syringe and needle
• Draw up the required volume of preservative-free 0.9% Sodium Chloride Injection, USP only (see dilution table below)
• Never use preserved saline or any other diluent 1

Reconstitute the vial:

• Insert the needle into the Dysport vial
• The partial vacuum will automatically pull saline into the vial
• Manually express any remaining required saline
• Do not use the vial if no partial vacuum is observed 1
• Swirl gently to dissolve - avoid aggressive shaking 1

Inspect the solution:

• The reconstituted solution should be clear, colorless, and free of particulate matter
• Do not inject if discolored or contains particles 1

Dilution Volumes by Vial Size

For 500 Unit Vial:

• 1 mL diluent → 50 Units/0.1 mL
• 2 mL diluent → 25 Units/0.1 mL
• 2.5 mL diluent → 20 Units/0.1 mL
• 5 mL diluent → 10 Units/0.1 mL (requires special two-step technique) 1

For 300 Unit Vial:

• 0.6 mL diluent → 50 Units/0.1 mL
• 1.5 mL diluent → 20 Units/0.1 mL
• 2.5 mL diluent → 12 Units/0.1 mL
• 3 mL diluent → 10 Units/0.1 mL 1

Special Technique for 5 mL Dilution (500 Unit Vial)

When using 5 mL of diluent for a 500 Unit vial, no more than 2.5 mL should be introduced directly into the vial. Follow this specific procedure:

1. Reconstitute the 500 Unit vial with 2.5 mL preservative-free saline, gently mix, set aside
2. Withdraw 2.5 mL preservative-free saline into a 5 mL syringe
3. Draw up the Dysport solution from the reconstituted vial without inverting
4. Mix gently
5. Use immediately after reconstitution in the syringe
6. Dispose of any unused saline 1

Critical Handling Considerations

Mechanical Stability During Reconstitution

Use large-bore needles and gentle technique to preserve potency. Research demonstrates that aggressive reconstitution can reduce potency by up to 42%. Specifically:

• Use large diameter needles (0.90 × 70 mm or larger) for reconstitution
• Perform only 2-3 injection-aspiration-injection cycles maximum
• Shake gently 2-3 times only to rinse the glass wall
• Avoid: Small diameter needles (0.40 × 40 mm), prolonged injection-aspiration cycles (>3), and violent shaking (>30 seconds) 2

The botulinum neurotoxin is a large double-stranded protein susceptible to mechanical stress. Aggressive reconstitution with small needles and excessive manipulation significantly increases time to paralysis in bioassays, correlating with substantial potency loss 2.

Needle Changes

Remove the reconstitution needle and attach a new sterile needle of appropriate size for injection before administering to the patient 1.

Storage After Reconstitution

Once reconstituted, Dysport may be stored refrigerated at 2°C to 8°C (36°F to 46°F), protected from light, for up to 24 hours. 1

• Must be discarded if not used within 24 hours
• Do not freeze reconstituted Dysport
• Store in original container
• Keep protected from light 1

Important caveat: While FDA labeling states 24-hour storage, expert consensus from dermatologic surgery supports that appropriately reconstituted botulinum toxin can be refrigerated or refrozen for at least 4 weeks without significant contamination risk or decreased effectiveness for facial muscle indications 3. However, the FDA-approved labeling should guide practice in therapeutic indications.

Single-Use vs. Multi-Patient Use

FDA labeling states: After reconstitution, Dysport should be used for only one injection session and for only one patient. Discard any unused portion 1.

Clinical practice note: Expert consensus in dermatologic surgery indicates that a single vial can be used to treat multiple patients with appropriate handling, though this represents off-label use 3. For therapeutic indications (cervical dystonia, spasticity), adherence to single-patient use per FDA labeling is recommended.

Concentration Selection by Indication

The recommended concentration varies by indication:

• Cervical Dystonia: 50 Units/0.1 mL or 25 Units/0.1 mL
• Glabellar Lines: 12 Units/0.1 mL or 20 Units/0.1 mL
• Adult Spasticity: 10 Units/0.1 mL or 20 Units/0.1 mL
• Pediatric Spasticity: 20 Units/0.1 mL or 50 Units/0.1 mL 1

Common Pitfalls to Avoid

1. Using preserved saline - Only preservative-free 0.9% sodium chloride is acceptable
2. Aggressive reconstitution - Can reduce potency by over 40% 2
3. Using vials without vacuum - Indicates compromised sterility
4. Freezing reconstituted product - Destroys the protein structure
5. Exceeding 24-hour storage - Per FDA labeling for therapeutic use
6. Not inspecting for particulates - Indicates protein denaturation
7. Confusing Dysport units with other botulinum toxin products - Units are NOT interchangeable 1