74 / 86
reconstitute the lyophilized powder in unpreserved
0.9% sodium chloride.
RimabotulinumtoxinB is provided as a ready-to-use
sterile liquid; no reconstitution is required.
20
Preserved Saline
A bilateral, comparative, prospective study in 100
cosmetic patients showed that preserved saline
(containing benzyl alcohol) used in reconstitution
did not affect the potency of onabotulinumtoxinA
and made the injection less painful.
23
Two other studies confirmed these observations:
one comparative, double-blind, side-by-side
controlled trial with 20 blepharospasm patients
33
and a single-blind study with 93 individuals injected
in the upper face, neck, and axillary regions.
34
A consensus panel held in 2004 chose preserved
saline as the preferred diluent for reconstitution of
onabotulinumtoxinA.
22
Another expert panel
recognized that benzyl alcohol may act as a local
anesthetic but considered that, at low volumes, this
effect is usually negligible.
32
Saline Plus Hyaluronidase
In 2003, Goodman
24
tested the viability of
onabotulinumtoxinA when reconstituted with saline
admixed with hyaluronidase and whether this
mixture could enhance the diffusion of the product.
The initial results (after 2 weeks) showed that the
mixture maintained the efficacy of onabotulinum-
toxinA and that there was greater diffusion of the
effect. No long-term results were evaluated.
Lidocaine and Epinephrine
In a double-blind, randomized, controlled study with
10 volunteers for cosmetic indication, Gassner and
Sherris
25
showed that, when onabotulinumtoxinA
was reconstituted with 1% lidocaine with 1:100,000
epinephrine, all components retained their function.
Haubner
35
found similar results in two cases,
TABLE 1.. Continued
OnabotulinumtoxinA AbobotulinumtoxinA BONTA
BONTA
IncobotulinumtoxinA RimabotulinumtoxinB
Dilution, mL
1.0–2.5
1.66–3.32
1.0–2.0
1.0–2.0
1.0–2.0
No reconstitution re-
quired
Storage after
dilution/tem-
perature
24 hours/2–8
1
C
4 hours/2–8
1
C
4 hours/2–8
1
C 4 hours/2–8
1
C 24 hours/2–8
1
C
4 hours (if diluted)/2–
8
1
C
http://www.accessdata.fda.gov/drugsatfda docs/nda/2009/125274s000ChemR.pdf (accessed October 1, 2010).
y
Li Biansheng. Injection of Botulinum Toxin A in Correcting Forehead Wrin-
kles. J Medl For 2005: 26(10):60-6. SNAP-25, synaptosomal membrane-associated protein with the molecular mass of 25 kDa; SV2, synaptic vesicle protein 2; HAS, human serum albumin;
NaCl, sodium chloride.
DERMATOLOG I C SURGERY
HANDL I NG BOTUL I NUM TOX I NS