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
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.
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.
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.
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 preexisting 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 determined.
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 cardiovascular disease.
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®
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 (3%).
The most frequently reported adverse event following injection of BOTOX®
Cosmetic for lateral canthal lines was eyelid edema (1%).
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 anticholinergic effects.
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 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 woman.
(bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.
(bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of
may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including
after consulting with their physician and should be monitored for changes to their intraocular pressure.
Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
solution comes in repeated contact with skin surfaces. Apply
solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.
The most frequently reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.
in clinical practice: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.
Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.