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Xeomin reconstitution instructions

Easy steps to reconstitute Xeomin® properly

Pre-Reconstitution: DRAW the Diluent
  • Determine the desired amount of preservative-free 0.9% Sodium Chloride to reconstitute either a 50 U or 100 U vial of Xeomin, using Table 3 in Section 2.8 of the Full Xeomin Prescribing Information.
  • Cleanse the rubber stopper of the Sodium Chloride vial using 70% alcohol.
  • Insert the 20-27 gauge short bevel needle, affixed to a syringe, into and through the rubber stopper. Then, draw up your selected amount of saline into the syringe.
Actual Reconstitution: ADD the Diluent
  1. Cleanse the rubber stopper of the selected Xeomin vial using 70% alcohol.
  2. Insert the 20-27 gauge needle attached to the saline-filled syringe into and through the rubber stopper of the Xeomin vial, allowing the Xeomin vial’s vacuum to draw the saline from the syringe into the vial. Gently inject any remaining saline in the syringe into the Xeomin vial, in order to avoid foam formation.
  3. Remove the needle (and its attached, emptied syringe) from the Xeomin vial. If there is no vacuum to pull the saline into the vial, then the Xeomin vial must be discarded.
  4. Mix the contents of the Xeomin vial by carefully swirling and inverting/flipping the vial. Do not vigorously shake.
Post-Reconstitution: DELIVER
  • Reconstituted Xeomin should be used for only one injection session and for one patient. Each Xeomin vial is for single-dose only. Discard any unused units.
  • Reconstituted Xeomin is ready for use and should be administered within 24 hours.
  • Reconstituted Xeomin not immediately used must be stored in its original vial and in a refrigerator 2°C - 8°C (36°F - 46°F) for up to 24 hours, until time of use.
Xeomin Injection Sites for Glabellar Lines

Dosing for Glabellar Lines

The total recommended Xeomin dose is 20 Units per treatment session divided into 5 equal intramuscular injections of 4 Units each. The 5 injection sites are: 2 injections in each corrugator muscle and one injection in the procerus muscle.1

Retreatment with Xeomin should be administered no more frequently than every 3 months.1

  1. Xeomin® (incobotulinumtoxinA) for injection, for intramuscular use. Prescribing Information. Merz Pharmaceuticals, LLC, 2018.

INDICATIONS AND USAGE

XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete BOXED WARNING.

 
The effects of XEOMIN® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN® was Headache (5.4%).

DRUG INTERACTIONS

Co-administration of XEOMIN® and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type muscle relaxants, should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN® may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use XEOMIN® in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN® in patients less than 18 years of age have not been established.

XEOMIN® is available only through licensed physicians.

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