Keywords
StorageNeurotoxin handlingNeurotoxin reconstitutionNeurotoxin dosingBotoxDysportXeominNeurotoxinTechniquePreparationJeuveau11.1 Storage
The medications come as either lyophilized (abobotulinumA or incobotulinumA) or vacuum-dried (onabotulinumA or prabotulinumtoxinA-xvfs) powder and are reconstituted with a diluent. Storage of onabotulinumA, abobotulinumA, and prabotulinumtoxinA-xvfs must be refrigerated at 2–8 °C (36–46 °F) before reconstitution. However, incobotulinumtoxinA can be stored at room temperature (68–77 °F), refrigerated (36–46 °F), or frozen (−4 to +14 °F) before reconstitution (Allergan 2017; Ipsen Biopharmaceuticals Inc 2017; Merz Pharmaceuticals LLC 2018). IncobotulinumtoxinA may be a feasible option in offices where refrigeration is not possible.
The lot number and expiration date are listed on the vial and should be documented in the patient record. After the number of units, lot number, and expiration date are confirmed, the plastic vial lid is removed, and the rubber stopper is cleaned with an alcohol wipe. There are two methods to introduce the diluent into the vial. One way is to use a sterile 20g needle, without an attached syringe and insert it into the rubber top to express the increased pressure from the vial. Some practitioners might prefer to use a 20g needle without an attached syringe for two reasons: (1) to hear the hiss of the vacuum release that ensures proper packaging, and (2) to control the speed and velocity of the diluent as it is vacuumed into the vial. The second method of reconstitution uses a sterile 20g needle to draw up the appropriate amount of diluent into a 3 mL syringe and insert the attached needle into the rubber top. Since the vial is vacuum sealed, this action will cause the diluent to be automatically pulled into the vial and combined with the neurotoxin. Either method is acceptable and is based on practitioner preference.
Pressure builds up during the packaging process and is a sign the BoNT/A is fresh and properly packaged. During preparation of BoNT/A, if the hiss of pressure release after the 20g needle insertion into the vial is not heard, or if the diluent is not automatically pulled into the vial by needle and syringe method, it is recommended to contact the BoNT/A manufacturer for further information. After confirming patency of the product, reconstitution with the appropriate diluent makes it possible to draw the solution into the syringe for injection into the target treatment site (Carruthers and Carruthers 2005a).
11.2 Preparation
Sterile, 0.9% sodium chloride or preservative-free 0.9% sodium chloride are the recommended reconstitution agents and there is no apparent difference in treatment onset, duration, or effect. All four commercially available brands must be stored at 2–8 °C after reconstitution. It is recommended that the reconstituted medication be used within 24 h to ensure potency (Allergan 2017; Ipsen Biopharmaceuticals Inc 2017; Merz Pharmaceuticals LLC 2018). Freezing any reconstituted neurotoxin solution is not recommended as it decreases or destroys the potency of the medication and renders it ineffective (Allergan 2017; Ipsen Biopharmaceuticals Inc 2017; Merz Pharmaceuticals LLC 2018).
Varying dosing concentrations
OnabotulinumtoxinA/PrabotulinumtoxinA | IncobotulinumtoxinA | AbobotulinumtoxinA |
---|---|---|
100-unit vial | 100-unit vial | 300-unit vialb |
1.0 mL 0.9% sodium chloridea = 10 units per 0.1 mL | 1.0 mL 0.9% sodium chloridea = 10 units per 0.1 mL | 1.0 mL 0.9% sodium chloridea = 30 units per 0.1 mL |
2.0 mL 0.9% sodium chloride = 5 units per 0.1 mL | 2.0 mL 0.9% sodium chloride = 5 units per 0.1 mL | 2.0 mL 0.9% sodium chloride = 15 units per 0.1 mL |
2.5 mL 0.9% sodium chloride = 4 units per 0.1 mL | 2.5 mL 0.9% sodium chloride = 4 units per 0.1 mL | 3.0 mL 0.9% sodium chloride = 10 units per 0.1 mL |
4.0 mL 0.9% sodium chloride = 2.5 units per 0.1 mL | 4.0 mL 0.9% sodium chloride = 2.5 units per 0.1 mL | 4.0 mL 0.9% sodium chloride = 7.5 units per 0.1 mL |
5.0 mL 0.9% sodium chloride = 2.0 units per 0.1 mL | 5.0 mL 0.9% sodium chloride = 2.0 units per 0.1 mL | 5.0 mL 0.9% sodium chloride = 6.0 units per 0.1 mL |