Approved April 30, 2009

ABOBOTULINUMTOXINA
(FDA Category Biologic)

DYSPORT(TM) (Tercica Inc./Medicis Aesthetics, Inc.) is a purified neurotoxin type A complex synthesized by Clostridium botulinum, that inhibits the release of acetylcholine from peripheral cholinergic nerve endings resulting in the localized reduction of muscle activity.

DOSING INFORMATION: An initial intramuscular dose of 500 units (divided among affected muscles) is recommended for patients with cervical dystonia with or without a prior history of tolerating botulism toxin. Subsequent dosing should be optimized by 250unit increments according to the patient's individual response and should not occur in intervals of less than 12 weeks. For the treatment of glabellar lines, an initial intramuscular dose of 50 units, given in 5 equal aliquots of 10 units each into each of 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle), is recommended. Repeated doses may be administered no more frequently than every 3 months, with a maximum of 4 injections.

CAUTIONS: Contraindicated in patients with a cow's milk protein allergy, injection-site infection, or history of hypersensitivity to a botulinum toxin product. Use with caution in patients with a neuromuscular disorder, facial asymmetry, surgical alterations to the facial anatomy, injection-site inflammation, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin. The most common adverse reactions associated with cervical dystonia treatment include muscular weakness, dry mouth, dysphagia, injection site discomfort/pain, dysphonia, fatigue, headache, musculoskeletal pain, and eye disorders. The most common adverse reactions associated with glabellar line treatment include injection site reaction/pain, headache, nasopharyngitis, upper respiratory tract infection, sinusitis, nausea, and eyelid edema and ptosis.

FDA APPROVED INDICATIONS: AbobotulinumtoxinA is indicated for the treatment of cervical dystonia with or without previous treatment with botulinum toxin in adults, and for the temporary improvement of the appearance of moderate to severe glabellar lines in adults less than 65 years of age.