BOTOX® Cosmetic (onabotulinumtoxinA) Important
Cosmetic 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 ≤ 65 years of age.
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
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) 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
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®
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.
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); and when used in patients
who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal
scarring, thick sebaceous skin or the inability to substantially lessen glabellar
lines by physically spreading them apart.
The most frequently reported adverse events following injection of BOTOX®
Cosmetic include blepharoptosis and nausea.
Co-administration of BOTOX® Cosmetic and aminoglycosides or other
agents interfering with neuromuscular transmission (eg, curare-like nondepolarizing
blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases,
succinylcholine chloride) 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 serotypes 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.
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or
Please see BOTOX® Cosmetic full
Prescribing Information including Boxed Warning and
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® (bimatoprost ophthalmic solution) 0.03%
is indicated to treat hypotrichosis of the eyelashes by increasing their growth,
including length, thickness, and darkness.
Important Safety Information
Warnings and Precautions: In patients using LUMIGAN®
(bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment
of elevated intraocular pressure (IOP), the concomitant use of LATISSE®
may interfere with the desired reduction in IOP. Patients using prostaglandin analogs
including LUMIGAN® for IOP reduction should only
use LATISSE® 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.
There is the potential for hair growth to occur in areas where LATISSE®
solution comes in repeated contact with skin surfaces. Apply LATISSE®
only to the skin of the upper eyelid margin at the base of the eyelashes.
LATISSE® solution should be used with caution in
patients with active intraocular inflammation (eg, uveitis) because the inflammation
may be exacerbated.
Adverse Reactions: 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.
Postmarketing Experience: The following reactions have been identified
during postmarketing use of LATISSE® 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 Specific Populations: 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.
For more information on LATISSE®, please see the full Prescribing Information.