Additional Safety Information – BOTOXCosmetic.com

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CONTRAINDICATION
BOTOX^® Cosmetic is contraindicated in the presence of infection at the proposed injection sites(s) and in individuals with known hypersensitivity to any ingredient in the formulation.

WARNINGS
Do not exceed the recommended dosage and frequency of administration of BOTOX^® Cosmetic. Risks resulting from administration of higher dosages are not known.

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
The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

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
In clinical trials of BOTOX^® Cosmetic, the most frequently reported adverse events following injection of BOTOX^® Cosmetic were headache, respiratory infection, flu syndrome, blepharoptosis, and nausea.

Less frequently occuring (< 3%) adverse reactions included pain in the face, erythema at the injection site and muscle weakness.

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.

Please see the additional safety information and full prescribing information.

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