BOTOX^® for injection is indicated for the treatment of upper limb spasticity in adult patients to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).

Safety and effectiveness of BOTOX^® have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of BOTOX^® have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX^® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX^® is not intended to substitute for usual standard of care rehabilitation regimens.

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

BOTOX^® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

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

The safety and effectiveness of BOTOX^® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX^® for palmar hyperhidrosis and facial hyperhidrosis, respectively. 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.

Safety and effectiveness of BOTOX^® have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.

BOTOX^® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

The potency Units of BOTOX^® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX^® cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.

See Boxed Warning.

No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX^® for blepharospasm at the recommended dose (30 Units and below) or for strabismus at the labeled doses have been reported.

Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX^® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.

Treatment with BOTOX^® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved (see Boxed Warning).

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX^®.

Patients with compromised respiratory status treated with BOTOX^® for upper limb spasticity should be monitored closely.

Reduced blinking from BOTOX^® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.

During the administration of BOTOX^® for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.

Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with BOTOX^® (3% at 251-360 Units total dose) compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX^® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%).

The following adverse reactions to BOTOX^® for injection are discussed in greater detail in the following sections: Spread of Toxin Effect (see Boxed Warning); Hypersensitivity Reactions (see Contraindications and Warnings and Precautions); Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity (see Warnings and Precautions).

The most frequently reported adverse reactions following injection of BOTOX^® for upper limb spasticity include pain in extremity, muscle weakness, fatigue, nausea, and bronchitis.

The most frequently reported adverse reactions following injection of BOTOX^® for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

The most frequently reported adverse reactions following injection of BOTOX^® for blepharospasm include ptosis (21%), superficial punctate keratitis (6%), and eye dryness (6%).

The most frequently reported adverse events following injection of BOTOX^® for strabismus include ptosis (15.7%) and vertical deviation (16.9%).

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

There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been 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.

Please see full prescribing information including Medication Guide.