BOTOX PATIENT ASSISTANCE™ Program

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BOTOX^® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

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. Patients 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^® treatment with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical BOTOX^® doses.

Adverse events
There have been rare spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have been rare reports of adverse events involving the cardiovascular system. The most frequently reported adverse reactions in patients with cervical dystonia following BOTOX^® injection are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

Please see full prescribing information for BOTOX^®.

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