BOTOX^® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

Important Safety Information

Contraindications
BOTOX^® treatment 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.

Warnings
The recommended dosage and frequency of administration for BOTOX^® should not be exceeded. Risks resulting from administration at 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^® injection should be discontinued and appropriate medical therapy immediately instituted. BOTOX^® should only be diluted with 0.9% nonpreserved sodium chloride.

Individuals with peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX^® with caution. 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^®.

Precautions
Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

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^® treatment in pregnant women. BOTOX^® should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks, including abortion or fetal malformations, which have been observed in rabbits.

Adverse Reactions
There have been rare reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.

The most frequently reported adverse events (3% to 10% of patients) following BOTOX^® injection for severe primary axillary hyperhidrosis included injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

Please see prescribing information.