Xeomin® Information

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Executive Summary

  • After a 10 month injunction, Xeomin is again being launched in the US as a treatment of glabellar lines
  • The main difference between Xeomin and Botox or Dysport, is that Xeomin contains just one ingredient: botulinum toxin A.
  • Xeomin is a “naked injectable,” meaning that it does not contain any additives. A benefit of a pure-form injectable is that the human body is less likely to become resistant to it.
  • Xeomin is the only one of the three (Xeomin, Botox and Dysport) that does not need to be refrigerated before use.
  • The cost of Xeomin is anticipated to be roughly the same as for Botox at $4.25 per unit*.  Botox is priced at $5.40 per unit and Dysport at $3.99 per unit.
  • Patients average 20 units of Xeomin per visit, vs. 20 units of Botox and 40 units of Dysport.
  • Xeomin might have the slowest “onset” of action of the 3 (Dysport onset in 24 hours, Botox onset in 72 hours, and Xeomin onset in 4 days.)
  • Xeomin may be “mildly more convenient” than Botox or Dysport, as the “product’s lack of complex proteins will help prevent antibody formation, or resistance to neuromuscular treatment with botulinum type A toxin, in patients being treated for neuromuscular conditions.”
  • There have been rumours that Xeomin “has a tendency to spread or migrate beyond the injection site.”

*Price not finalized.

Xeomin has available outside the US since 2005, and was introduced in the US in 2010.  Xeomin was given the FDA approval in July 2011 for the treatment of cervical dystonia, blepharospasm, and glabellar lines, but an injuction halted the release.  Now, after a 10 month injunction, Xeomin is again being launched in the US as a treatment of glabellar lines.  Xeomin®, by Merz Pharmaceuticals LLC, is a competitor to the well established Botox Cosmetic® and lesser used Dysport®.

Xeomin does not contain any additives. Patients are less likely to become resistant to Xeomin because there are simply less ingredients in the solution. Some patients have developed antibodies to Botox and Dysport. (Source:  http://www.botoxforum.com/articles/xeomin/75).

Instructions for Preparation, Dosage and Administration

Xeomin is supplied in vials containing 50 or 100 Units of incobotulinumtoxinA, 1 mg of human albumin, and 4.7 mg sucrose. Xeomin should be reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, USP.  Reconstituted XEOMIN solution should be administered within 24 hours after dilution.  During this time period, reconstituted XEOMIN should be stored in a refrigerator 2-8°C (36-46°F).

Xeomin does not need to be refrigerated prior to reconstitution and has a shelf life of 3 years.

Reconstitution instructions are provided for both vial volumes:

Volume of Preservative-free 0.9% Sodium Chloride Injection, USP

50 Unit Vial:  Resulting dose in   Units per 0.1 mL

100 Unit Vial:  Resulting does   in Units per 0.1 mL

0.25 mL

20 Units

-

0.5 mL

10 Units

20 Units

1 mL

5 Units

10 Units

1.25 mL

4 Units

8 Units

2 mL

2.5 Units

5 Units

2.5 mL

2 Units

4 Units

4 mL

1.25 Units

2.5 Units

5 mL

1 Unit

2 Units

8 mL

-

1.25 Units

 

The total recommended XEOMIN dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each. The five injection sites are:

  • two injections in each corrugator muscle and one injection in the procerus muscle.

Retreatment with XEOMIN should be administered no more frequently than every three months.

A suitable sterile needle 30-33 gauge (0.3-0.2 mm diameter), 13 mm length should be used in the administration in the treatment of glabellar lines.

The median first onset of XEOMIN effect occurs within seven days after injection. The typical duration of effect of each treatment is 3-4 months, but effects can last up to 6 months.

Cost

The cost for Botox® is approximately $5.40 per unit (cost to physicians is $540 for a 100 Unit vial) vs. Dysport® at $3.99 per unit.  However among physicians, it has been debated, yet somewhat accepted, that 1 unit of Botox® is “similar” to 3 units of Dysport®, or 20 unites of Botox® and Xeomin® is equal to 60 units of Dysport®  ( i.e. 3:1 ratio).

The cost for Xeomin is reported to be slightly less, but roughly the same as the cost of Botox ®.*

It is anticipated that the average retail cost to a patient in the US, for a Xeomin treatment, is between $300.00 – $400.00 every 3 months.  Again, the total recommended XEOMIN dose is 20 Units per treatment session.

*Price not finalized.

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