Indication
BOTOX
® 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.
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.
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) 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.
Hypersensitivity Reactions
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.
Cardiovascular System
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
® Cosmetic.
Human Albumin
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.
BOTOX
® Cosmetic is not recommended for use in children or pregnant women.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.
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. 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.
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.
Click here for full LATISSE® Prescribing Information.