| Dear Allergan customer:
Thank you for your interest in using BOTOX® Cosmetic (onabotulinumtoxinA)
materials in your practice. Allergan is committed to
helping aesthetic practices grow and succeed with
practice-building programs and tools.
The attached file contains the updated BOTOX® Cosmetic
logo with the new nonproprietary name,
onabotulinumtoxinA, along with the Important Safety
Information and full product information and Medication
Guide. These should be used in any material you may
develop for your practice.
Please follow the instructions below when you use the
logo, brand name, or branding images:
1. The Important Safety Information must be displayed
whenever the BOTOX® Cosmetic logo appears. You may use
the attached PDF of this information to copy and paste
into your promotional materials.
2. The Important Safety Information should not be
changed in any way. It cannot be abbreviated or altered.
3. The full product information including Medication
Guide should be given out any time a patient is treated
with BOTOX® Cosmetic. These items should also accompany
any material you distribute that contains the BOTOX®
Cosmetic logo or brand name.
Also included is an example of a BOTOX® Cosmetic
promotional piece that shows the correct use and layout
of the Important Safety Information.
Indication
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.
IMPORTANT SAFETY INFORMATION
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,
blurred vision, 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 underlying
conditions that would predispose them to these symptoms.
In unapproved uses, including spasticity in children and
adults, and in approved indications, cases of spread of
effect have occurred at doses comparable to those used
to treat cervical dystonia and at lower doses.
Contraindications
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
The recommended dosage and frequency of administration
for BOTOX® Cosmetic should not be exceeded. Risks
resulting from administration at higher dosages are not
known.
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 or
converted into units of any other botulinum toxin
products assessed with any other specific assay method.
Spread of Toxin Effect
Postmarketing safety data from BOTOX® Cosmetic and other
approved botulinum toxins suggest that botulinum toxin
effects may, in some cases, be observed beyond the site
of local injection. The symptoms are consistent with the
mechanism of action of botulinum toxin and may include
asthenia, generalized muscle weakness, diplopia, blurred
vision, 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
related to spread of toxin effects. 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, and particularly in
those patients who have underlying conditions that would
predispose them to these symptoms. In unapproved uses,
including spasticity in children and adults, and in
approved indications, symptoms consistent with spread of
toxin effect have been reported at doses comparable to
or lower than doses used to treat cervical dystonia.
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.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have
been reported. These reactions include anaphylaxis,
urticaria, soft tissue edema, and dyspnea.
Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases,
amyotrophic lateral sclerosis, or neuromuscular
junctional disorders (e.g., 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.
Adverse Reactions
General
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.
Overdosage
Excessive doses of BOTOX® Cosmetic may be expected to
produce neuromuscular weakness with a variety of
symptoms. Respiratory support may be required where
excessive doses cause paralysis of respiratory muscles.
In the event of overdose, the patient should be
medically monitored for symptoms of excessive muscle
weakness or muscle paralysis.
In the event of suspected or actual overdosage, please
contact your local or state Health Department to process
a request for antitoxin through the CDC. If you do not
receive a response within 30 minutes, please contact the
CDC directly at 1-770-488-7100.
Please
click here for full prescribing
information including Medication Guide.
Thank you for your continued support of BOTOX® Cosmetic.
If you have any questions, please contact your Business
Development Manager.
Sincerely,
Allergan Marketing
©2009 Allergan, Inc., Irvine, CA 92612 ® and T marks
owned by Allergan,
Inc.
www.botoxcosmetic.com 1-800-BOTOXMD APC21XS09 903328
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