BOTOX® (onabotulinumtoxinA) Reconstitution

Allergan recommends the BOTOX® 200-Unit vial for the treatment of Chronic Migraine patients, since the recommended dose is 155 Units.

See the detailed steps below or watch a video of the reconstitution procedure.

200-Unit Vial Dilution

BOTOX® (onabotulinumtoxinA) vial
Dilution
Saline Added
(0.9% sodium chloride for injection)*
Resulting BOTOX® Dose
(Units per 0.1 mL)
4.0 mL 5.0 Units

*Preservative-free injection, USP only.

Reconstitution procedure

Step 1: Clean the rubber stoppers of the vial of preservative-free 0.9% sodium chloride and the 200-Unit BOTOX® vial with an alcohol swab.
Step 2: Using a 2-in needle attached to a 5-mL syringe, withdraw 4 mL of saline.
Step 3: Using a 45° angle, insert the needle of the syringe containing saline into the center of the rubber stopper on the BOTOX® vial and allow the vacuum to pull the saline into the vial.
Step 4: Do not use the BOTOX® vial if the vacuum does not pull all the saline into the vial.
Step 5: Leave the reconstitution needle with attached reconstitution syringe in the bottle while gently rotating the vial to mix the BOTOX® neurotoxin with the saline

NOTE: Administer BOTOX® within 24 hours of reconstitution in the vial; during this period reconstituted BOTOX® should be stored in a refrigerator (2°C to 8°C).

Preparation of injection syringes

Step 1: Hold the hub of the needle and remove the reconstitution syringe, and replace it with a 1-mL injection syringe.
Step 2: Withdraw 1 mL of the reconstituted solution into the 1-mL injection syringe. You may need to tilt the vial slightly to withdraw a full 1 mL.
• Do not invert the BOTOX® vial when withdrawing the solution into the 1-mL    injection syringe.
Step 3: Disconnect the first 1-mL injection syringe from the hub of the needle.
Step 4: Attach a 30-gauge, 0.5-in needle for injection to the syringe.
Step 5: Repeat the BOTOX® withdrawal procedure with 3 additional 1-mL injection syringes.

Upon completion of the reconstitution of BOTOX® neurotoxin, you should have four 1-mL injection syringes, each filled with 1 mL and 50 Units of BOTOX® solution and each with a 30-gauge, 0.5-in needle attached.

Supplies

• One 200-Unit vial of BOTOX® neurotoxin
    - Please ensure you have received authentic BOTOX® product from Allergan. Look
      for the holographic film on the vial; "ALLERGAN" should appear within rainbow
      lines
• One 21-gauge, 2-in needle for drawing up the saline diluent
• One 5-mL syringe for diluent
• Reconstitution syringe labels
• Four 1-mL tuberculin syringes with 1/100th-mm gradations
  NOTE: Many physicians prefer to use a Luer-Lok® syringe to ensure no liquid is lost
  and the needle stays in place.
One 10-mL, single-use vial of preservative-free, 0.9% sodium chloride (saline)
Four 30-gauge, 0.5-in injection needles
Alcohol swabs for cleaning the rubber stoppers on the saline and BOTOX® vials

100-Unit Vial Dilution

BOTOX® (onabotulinumtoxinA) vial
Dilution
Saline Added
(0.9% sodium chloride for injection)*
Resulting BOTOX® Dose
(Units per 0.1 mL)
2.0 mL 5.0 Units

*Preservative-free injection, USP only.

NOTE: To accurately administer the 155 Units recommended for Chronic Migraine injections, two 100-Unit vials must be reconstituted with preservative-free saline.

Reconstitution procedure

Step 1: Clean the rubber stoppers of the vial of preservative-free 0.9% sodium chloride and the 100-Unit BOTOX® vial with an alcohol swab.
Step 2: Using a 2-in needle attached to a 5-mL syringe, withdraw 2 mL of saline.
Step 3: Using a 45° angle, insert the needle of the syringe containing saline into the center of the rubber stopper on the BOTOX® vial and allow the vacuum to pull the saline into the vial.
Step 4: Do not use the BOTOX® vial if the vacuum does not pull all the saline into the vial.
Step 5: Leave the reconstitution needle with attached reconstitution syringe in the bottle while gently rotating the vial to mix the BOTOX® neurotoxin with the saline

Repeat these steps for the second vial.

NOTE: Administer BOTOX® within 24 hours of reconstitution in the vial; during this
period reconstituted BOTOX® should be stored in a refrigerator (2°C to 8°C).

Preparation of injection syringes

Step 1: Hold the hub of the needle and remove the reconstitution syringe, and replace it with a 1-mL injection syringe.
Step 2: Withdraw 1 mL of the reconstituted solution into the 1-mL injection syringe. You may need to tilt the vial slightly to withdraw a full 1 mL.
• Do not invert the BOTOX® vial when withdrawing the solution into the 1-mL    injection syringe
Step 3: Disconnect the first 1-mL injection syringe from the hub of the needle.
Step 4: Attach a 30-gauge, 0.5-in needle for injection to the syringe.
Step 5: Repeat the BOTOX® withdrawal procedure with 3 additional 1-mL injection syringes.

Upon completion of the reconstitution of BOTOX® neurotoxin, you should have four 1-mL injection syringes, each filled with 1 mL and 50 Units of BOTOX® solution and each with a 30-gauge, 0.5-in needle attached.

Supplies

• Two 100-Unit vials of BOTOX® neurotoxin
    - Please ensure you have received authentic BOTOX® product from Allergan. Look
      for the holographic film on the vial; "ALLERGAN" should appear within rainbow
      lines
• Two 21-gauge, 2-in needles for drawing up the saline diluents
• Two 5-mL syringes for diluent
• Reconstitution syringe labels
• Four 1-mL tuberculin syringes with 1/100th-mm gradations
  NOTE: Many physicians prefer to use a Luer-Lok® syringe to ensure no liquid is lost
  and the needle stays in place.
One 10-mL, single-use vial of preservative-free, 0.9% sodium chloride (saline)
Four 30-gauge, 0.5-in injection needles
Alcohol swabs for cleaning the rubber stoppers on the saline and BOTOX® vials