Section 4 Plastic and Reconstructive Problems

HANDL I NG BOTUL I NUM TOX I NS

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

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

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 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. 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

DERMATOLOG I C SURGERY