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Initially, it was believed that BoNTA was fragile
and susceptible to surface denaturation.
11,12
A
variety of conditions have been postulated to affect
the potency of BoNTs, and different authors and
manufacturers made many recommendations
concerning reconstitution and storage of the agent
in order not to interfere with its efficacy or
duration. During these more than 20 years of
clinical use, some of these initial ideas have changed,
and others have remained stable with our
growing experience with and knowledge about
BoNTs.
The objective of this article was to review the
medical literature and prescribing information on all
of the available products and to update the concept
of handling toxins, although this is not a Cochrane
type analysis. It will be divided into five sections:
preparations, reconstitution, storage, sterility, and
dilution.
Preparations
BoNT formulations are not identical or inter-
changeable.
13
They possess individual potencies,
and attention is required to ensure proper use and
avoid errors. In April 2009, the FDA established
drug names to reinforce these differences and pre-
vent potential serious risks associated with these
medications.
14
Currently, only one form of BoNTB (rimabotuli-
numtoxinB) is available, under the trade name
of Myobloc/Neurobloc (Solstice Neurosciences Inc./
Eisai Co., Ltd.) in the United States and Neurobloc
in Europe. The U.S. FDA approved it for cervical
dystonia in 2001.
There are five sources of BoNTA available world-
wide:
1. OnabotulinumtoxinA: Botox/Botox Cosmetic
in the United States, Latin America (Allergan, Inc.,
Irvine, CA), also known as Vistabel in Europe and
Vistabex in Italy.
2. AbobotulinumtoxinA: Dysport (Ipsen Ltd.,
Berkshire, UK) in the United States, Europe, and
Latin America and Azzalure in Europe.
3. BoNTA Prosigne (Lanzhou, China) in Asia and
Latin America.
4. BoNTA Neuronox (Medy-Tox Inc., South Korea)
5. IncobotulinumtoxinA: Xeomin, (Merz Pharma,
Frankfurt) in Canada, Germany, the United States
(for therapeutic use), and Latin America and
Bocouture in Europe and Latin America.
Another product, BoNTA PureTox (Mentor Corpo-
ration, Santa Barbara, CA), similar to Xeomin, is an
uncomplexed type A toxin and has completed phase
III trials.
BoNTs manufacturer recommendations on supply,
dilution, and storage are summarized in Table 1.
15–20
Reconstitution
Published information about variations in reconsti-
tution methods, including agitation or foam
formation and mixtures of toxins with several
substances is reviewed in this section.
Unpreserved Saline
OnabotulinumtoxinA is the most studied type of
BoNTA, and as a consequence, the majority of the
information about handling BoNTs is found with
this brand. Initially, the product was thought to be
fragile.
11,12
Later, many studies following anecdotal
observations confirmed the persistence of activity of
BoNTA in different situations.
21–32
Most manufacturers recommend that BoNTA
reconstitution be performed using unpreserved
saline.
15–19
In a recent international consensus on the use of
abobotulinumtoxinA,
32
the recommendation was to
DERMATOLOG I C SURGERY
HANDL I NG BOTUL I NUM TOX I NS