BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.
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.
The recommended dosage and frequency of administration for BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are not known.
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. Some patients had pre-existing dysphagia or significant debility. (Safety and effectiveness have not been established for indications pertaining to these injection sites.) 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, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, 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.
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.
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) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Caution should be used when BOTOX® Cosmetic treatment is used in patients who have an inflammatory skin problem at the injection site, 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.
Information for Patients
Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.
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.
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.
Administration of BOTOX® Cosmetic is not recommended during pregnancy. There are no adequate and well-controlled studies of BOTOX® Cosmetic in pregnant women.
It is not known whether BOTOX® Cosmetic is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.
The most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility.
There have also been reports 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.
The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.
For more information on BOTOX® Cosmetic, please see the accompanying full Prescribing Information including Boxed Warning and Medication Guide.
Important JUVÉDERM® XC Safety Information
JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Side effects are usually mild to moderate, lasting 7 days or less, and include temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies.
For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.