|BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of
moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal
lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may
spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may
include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary
incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk
of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults
treated for spasticity and other conditions, particularly in those patients who have an underlying condition
that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in
approved indications, cases of spread of effect have been reported at doses comparable to those used to
treat cervical dystonia and at lower doses.
BOTOX® Cosmetic 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.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic 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®Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed
with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of
BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for
simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.
Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal
outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-
lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications
pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax
associated with injection procedure has been reported following the administration of BOTOX® near the thorax.
Caution is warranted when injecting in proximity to the lung, particularly the apices.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum
sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic
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
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors
including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing
Pre-existing Neuromuscular Disorders
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®Cosmetic.
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed
injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product
manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for
transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been identified for albumin.
The most frequently reported adverse event following injection of BOTOX®Cosmetic for glabellar lines was eyelid ptosis
The most frequently reported adverse event following injection of BOTOX®Cosmetic for lateral canthal lines was eyelid
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular
transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be
potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic
The effect of administering different botulinum neurotoxin products 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.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX®
Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.