XEOMIN^® Reconstitution and Storage

• Prior to injection, reconstitute each vial of XEOMIN® (incobotulinumtoxinA) with sterile, preservative-free 0.9% Sodium chloride Injection USP. Draw up an appropriate amount of 0.9% saline solution into a syringe (see Table).
• Clean the exposed portion of the rubber stopper of the vial with alcohol (70%) prior to insertion of the needle. Gently inject the saline solution into the vial. If the vacuum does not pull the solvent into the vial, then XEOMIN® (incobotulinumtoxinA) must be discarded.
• Gently mix XEOMIN® (incobotulinumtoxinA) with the saline by rotating the vial. Invert the vial containing the reconstituted XEOMIN 2 – 4 times to ensure all the XEOMIN is off the rubber stopper. Reconstituted XEOMIN® (incobotulinumtoxinA) is a clear, colorless solution free of particulate matter. XEOMIN® (incobotulinumtoxinA) should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.

Table: Diluent Volumes for Reconstitution of XEOMIN® (incobotulinumtoxinA)

• Intended for intramuscular injection only
• Should be used for only one injection session and only one patient
• Number of injection sites depends on size of muscle to be treated and volume of reconstituted XEOMIN injected
• Median onset of effect occurs within 7 days. Typical duration of effect of each treatment up to 3 months

Reconstituted XEOMIN® (incobotulinumtoxinA) solution should be administered within 24 hours after dilution. During this time period, reconstituted XEOMIN® (incobotulinumtoxinA) should be stored in a refrigerator 2-8°C (36-46°F).

Storage

Unopened vials of XEOMIN® (incobotulinumtoxinA) can be stored at room temperature 20 to 25°C (68 to 77° F), in a refrigerator at 2 to 8°C (36 to 46°F), or a freezer at -20 to -10°C ( -4 to 14°F) for up to 36 months. Do not use after the expiration date on the vial. Reconstituted XEOMIN® (incobotulinumtoxinA) should be stored in a refrigerator at 2 to 8°C (36 to 46°F) and administered within 24 hours.