Manufacturer: Allergan Pharmaceuticals
Indication: To treat severe underarm sweating (primary axillary hyperhidrosis) that cannot be managed by topical agents such as prescription antiperspirants.
Drug Class: Botulinum toxin type A is a protein that is produced by the bacterium Clostridium botulinum. Sterile, vacuum-dried, and purified, it is made from fermentation of Hall strain C. botulinum type A, which is grown in a medium containing casein hydrolysate, glucose, and yeast extract.
Uniqueness of Drug: When Botox® is used to treat primary axillary hyperhidrosis, small doses of an injectable form of the sterile purified botulinum toxin stop the release of the chemical messenger acetylcholine, temporarily blocking the nerves in the underarm that stimulate sweating.
Warnings: The recommended dosage and frequency of administration for botulinum toxin should not be exceeded. Risks resulting from higher dosages are not known.
Hypersensitivity Reactions. Serious and immediate hypersensitivity reactions have been reported rarely but include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. In one fatal case of anaphylaxis, lidocaine was used as the diluent. As a result, the causal agent cannot be reliably determined. If such a reaction occurs, further injection of botulinum toxin should be discontinued and appropriate medical therapy should be instituted immediately.
Pre-existing Neuromuscular Disorders. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) should receive botulinum toxin only with caution. Patients with neuromuscular disorders may be at an increased risk of clinically significant systemic effects, including severe dys-phagia (swallowing difficulty) and respiratory compromise from typical doses of the toxin. In rare cases, patients with known or unrecognized neuromuscular disorders who were given botulinum toxin showed extreme sensitivity to the systemic effects of typical clinical doses. In some of these patients, dysphagia lasted for several months and a gastric feeding tube was necessary.
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Dysphagia. Dysphagia is a commonly reported adverse event following treatment of cervical dystonia in patients with all botulinum toxins. In these patients, there have been reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. In one case, a patient developed aspiration pneumonia and died subsequent to the finding of dysphagia.
Human Albumin. The product contains albumin, a derivative of human blood. With effective donor screening and product manufacturing processes, it carries an extremely remote risk for the transmission of viral diseases. A theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD) is also considered remote. No cases of transmission of viral diseases or CJD have ever been identified as a result of albumin.
Precautions: The safe and effective use of botulinum toxin depends on proper storage of the product, the selection of the correct dose, and proper reconstitution and administration techniques. Caution is necessary with botulinum toxin treatment if inflammation is present at the proposed injection site.
Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without a confirmed diagnosis or treatment of the underlying disease. The safety and effectiveness of botulinum toxin for treating hyperhidrosis in other body areas have not been established.
Weakness of hand muscles may occur in patients who are receiving botulinum toxin for palmar hyperhidrosis, and bleph-aroptosis (drooping of the upper eyelid) may result when the drug is used to treat facial hyperhidrosis.
Dosage and Administration: Injections are prepared by drawing into an appropriately sized sterile syringe an amount of the properly reconstituted toxin slightly greater than the intended dose. Air bubbles in the syringe barrel are expelled, and the syringe is attached to an appropriate injection needle. The patency of the needle should be confirmed. A new sterile needle and syringe should be used to enter the vial on each occasion for removal of the toxin.
P&T Committee Considerations: Before being treated for primary axillary hyperhidrosis, patients should be evaluated for other potential causes of the problem, such as hyperthyroidism, to avoid symptomatic therapy for hyperhidrosis with botulinum toxin without addressing a potentially serious underlying disease that warrants other forms of treatment. After all other causes of axillary hyperhidrosis have been excluded, it is recommended that this botulinum product be considered for placement on the formulary to inhibit severe underarm sweating.