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Executive Summary

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®.

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.

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

 

Re-treatment 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 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 $100.00 – $600.00 every 3-4 months.  It is dependent on the areas treated.

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