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BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age. Important Safety Information BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. There have been rare reports of adverse events involving the cardiovascular system. Serious and/or immediate hypersensitivity reactions have been reported rarely. These reactions include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. The most common adverse events following injection include blepharoptosis and
nausea. Localized pain, infection, inflammation, tenderness, swelling, erythema
and/or bleeding/bruising may be associated with the injection. Patients with
neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton
syndrome may be at increased risk of serious adverse events.
CONTRAINDICATIONS WARNINGS Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further BOTOX® Cosmetic injection should be discontinued and appropriate medical therapy immediately instituted. BOTOX® Cosmetic should only be diluted with 0.9% nonpreserved sodium chloride. Other diluents, including lidocaine, should not be used for reconstitution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic. PRECAUTIONS There are no adequate and well-controlled studies of BOTOX® Cosmetic in pregnant women. When pregnant mice and rats were injected intramuscularly during the period of organogenesis, the developmental NOEL (No Observed Effect Level) of BOTOX® Cosmetic was 4 U/kg. Higher doses (8 or 16 U/kg) were associated with reductions in fetal body weights and/or delayed ossification. In a range finding study in rabbits, daily injection of 0.125 U/kg/day (days 6 to 18 of gestation) and 2 U/kg (days 6 and 13 of gestation) produced severe maternal toxicity, abortions, and/or fetal malformations. Higher doses resulted in death of the dams. The rabbit appears to be a very sensitive species to BOTOX® Cosmetic. If the patient becomes pregnant after the administration of this drug, the patient should be apprised of the potential risks, including abortion or fetal malformations that have been observed in rabbits. ADVERSE EVENTS Less frequently occuring (< 3%) adverse reactions included pain in the face, erythema at the injection site and muscle weakness.
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