Frequently Asked
Questions about Botox
What
is Botox?
BOTOX® is a formulation
of botulinum toxin type A. It is derived from the bacterium Clostridium
botulinum. This bacterium produces a protein that blocks the release
of acetylcholine and relaxes muscles. Type A is just one of seven
different types of botulinum toxin (A, B, C1, D, E, F, and G), and
each has different properties and actions. No two of these botulinum
toxins are alike.
More than 100 years of
research have expanded our knowledge of botulinum toxin type A from
the identification of the bacterium Clostridium botulinum to the
commercialization of botulinum toxin type A as BOTOX®.
In the 1960s, the muscle-relaxing
properties of botulinum toxin type A were tapped for investigational
use in realigning crossed eyes. These early studies paved the way
for treating other conditions caused by overactive muscles with
botulinum toxin type A.
Today, BOTOX® is
produced in controlled laboratory conditions and given in extremely
small therapeutic doses. It has helped over 1 million patients worldwide
with conditions caused by overactive muscles.
BOTOX® is indicated
for the treatment of cervical dystonia in adults to decrease the
severity of abnormal head position and associated neck pain. BOTOX®
is also indicated for the treatment of blepharospasm associated
with dystonia, including benign essential blepharospasm or VII nerve
disorders in people 12 years of age and above.
The most frequently reported adverse reactions in patients with
blepharospasm are drooping of the eyelid (21%), superficial punctate
keratitis (microscopic corneal errosions)(6%), and eye dryness (6%).
Patients with neuromuscular disorders may be at increased risk of
clinically significant systemic effects including severe dysphagia
and respiratory compromise from typical doses of BOTOX®. BOTOX®
is contraindicated in the presence of infection at the proposed
injection site(s). The effects of BOTOX® therapy may be increased
with the use of aminoglycoside antibiotics or with other drugs that
interfere with neuromuscular transmission.
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Is
Botox a new treatment?
No. BOTOX® has been
used for more than 11 years to treat over 1 million patients worldwide,
and it is approved by the health ministries of at least 70 countries.
BOTOX® has also been endorsed by the American Academy of Neurology
and the National Institutes of Health since 1990.
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How
is Botox different from oral treatments?
When drugs are taken
by mouth, they are distributed throughout the body by the blood
system.
In contrast, BOTOX® injections are administered directly into
the desired site of action. BOTOX® is not expected to be present
in the bloodstream at measurable levels following treatment at the
recommended dosage, and typically remains in the injected muscle,
although some spread to the adjacent muscle may occur.
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How
do we develop Wrinkles?
We develop two types
of wrinkles on our faces:
Dynamic wrinkles- These are wrinkles we are born with which are
associated with the muscles we use for facial expression. As we
continuously use our facial muscles to smile, laugh and squint,
mild wrinkles appear when we are young, but they become deeper and
more noticeable as we grow older. The most common areas where we
develop dynamic wrinkles are around the lips, the corners of the
eyelids (where the wrinkles are known as crows’ feet), between
the eyebrows, and on the forehead. These wrinkles often make people
look older and more tired than they actually are. Botox can be used
to treat these dynamic wrinkles and make them less noticeable.
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How
does Botox work?
Normally, your brain
sends electrochemical messages to your muscles to make them contract
and move. These messages are transmitted from a nerve to the muscle
by a substance called acetylcholine. When too much acetylcholine
is released, muscles become overly active and spasm or tense up.
BOTOX® blocks the nerve from releasing acetylcholine. As a result,
the muscle spasms stop or are greatly reduced, providing relief
from symptoms. Your health care provider will know how much BOTOX®
is needed to treat you effectively. It's important to remember that
botulinum toxin treatment is not a cure. For many people, however,
its effects have been dramatic. With BOTOX®, the nerve will
take about 3 months to recover and begin to release acetylcholine,
and the muscles may become overactive again. At that point, another
injection will be needed to provide relief, as long as no allergic
reactions or other significant side effects occurred and clinical
response was obtained.
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How
long can I be treated with Botox?
Each treatment typically
lasts up to 3 months and can be repeated as long as your condition
responds to BOTOX® and you do not have any serious allergic
reactions or other significant side effects. BOTOX® has been
used for more than 11 years to treat more than 1 million patients
worldwide, and although formal, long-term clinical evaluations have
not been conducted; its safety in long-term use has been well established.
Although most people
continue to respond to BOTOX® injections, some people have experienced
a diminished response over time. There may be several explanations
for this:
1. Changes in your condition - If the pattern of your muscle activity
changes, your health care provider may need to inject new muscles
and/or change your dose. Identifying and injecting the affected
muscle can be difficult, complicated by the changing pattern of
muscle involvement and progression of the disorder.
2. Setting appropriate expectations - You may believe your first
BOTOX® injection was more helpful than subsequent injections.
That's because your condition was perhaps quite severe when you
had your first injection. Subsequent injections are usually given
before your condition becomes that severe again. Therefore, the
relief you experienced with subsequent injections may not have been
as dramatic as the first time.
3. Antibody formation - When foreign proteins, like botulinum toxins,
enter your body, antibodies may form. If antibodies to botulinum
toxin develop, you may no longer respond to treatment.
Because botulinum toxins are usually used to treat chronic conditions,
it's important to preserve responsiveness to therapy.
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How
can I help maintain my response to Botox?
While the critical factors
for neutralizing antibody formation have not been well characterized,
you may be able to help maintain your response to BOTOX® by
minimizing your total exposure. The potential for antibody formation
may be minimized by injecting with the lowest effective dose given
at the longest feasible intervals between injections.
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How
is Botox given?
BOTOX® is injected
into the affected muscle(s). Your doctor will determine which muscles
need to be treated.
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Does
the injection hurt?
Some people report minor,
temporary discomfort from the injection. BOTOX® is reconstituted
with sterile, preservative-free, normal saline for injection. The
neutral pH of the injected solution, in combination with the fine-gauge
needle your doctor will use, can help to minimize any injection-related
pain.
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When
will Botox start to work?
If you're receiving
BOTOX® for blepharospasm, you'll usually see effects within
3 days.
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How
long will the effect last?
BOTOX® offers sustained
relief, dose after dose. The relief you'll feel from one treatment
of BOTOX® will normally last for up to 3 months. Treatments
can be continued as long as your condition responds to BOTOX®,
and you do not have any serious allergic reactions or other significant
side effects. When the relief begins to fade, you'll return to your
doctor for your next treatment. Usually, BOTOX® treatment is
required approximately four times per year. Because symptoms can
change over time, the amount and duration of relief you'll experience
can vary. Consult your doctor, who can determine how to achieve
the best possible results with BOTOX®.
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What
side effects have been seen with Botox?
The most frequently
reported treatment-related adverse reactions in patients receiving
BOTOX® for the treatment of blepharospasm are ptosis (droopy
eyelids, 21%), superficial punctuate keratitis (inflammation of
the cornea characterized by small erosions of the tissue covering
the cornea, 6%), and eye dryness (6%). Reduced blinking from BOTOX®
injection of the orbicularis muscle can lead to corneal exposure,
persistent epithelial defect (a defect in the corneal covering)
and corneal ulceration (a hollowed-out cavity in the cornea), especially
in patients with VII nerve disorders.
In general, adverse reactions
occur within the first week following injection of BOTOX® and,
while generally transient, may last several months. Localized pain,
tenderness and/or bruising may be associated with the injection.
Local weakness of the injected muscle(s) represents the expected
pharmacological action of botulinum toxin. However, weakness of
adjacent muscles may also occur due to spread of toxin.
Please seek immediate
medical attention if swallowing, speech, or respiratory (breathing)
disorders arise.
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Is
Botox right for me?
The most frequently
reported treatment-related adverse reactions in patients receiving
BOTOX® for the treatment of blepharospasm are ptosis (droopy
eyelids, 21%), superficial punctuate keratitis (inflammation of
the cornea characterized by small erosions of the tissue covering
the cornea, 6%), and eye dryness (6%). Reduced blinking from BOTOX®
injection of the orbicularis muscle can lead to corneal exposure,
persistent epithelial defect (a defect in the corneal covering)
and corneal ulceration (a hollowed-out cavity in the cornea), especially
in patients with VII nerve disorders.
In general, adverse reactions
occur within the first week following injection of BOTOX® and,
while generally transient, may last several months. Localized pain,
tenderness and/or bruising may be associated with the injection.
Local weakness of the injected muscle(s) represents the expected
pharmacological action of botulinum toxin. However, weakness of
adjacent muscles may also occur due to spread of toxin.
Please seek immediate
medical attention if swallowing, speech, or respiratory (breathing)
disorders arise.
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How
can I find out if my insurance covers Botox?
The BOTOX ADVANTAGETM
Program Reimbursement Hotline has been helping patients and physicians
get answers to their BOTOX® reimbursement questions for years.
In addition, BOTOX® has more than a decade of reimbursement
experience with insurance carriers and health care providers. It
is this experience that has resulted in BOTOX® coverage by most
payers, including Medicare and Medicaid; particularly for cervical
dystonia.
Some insurance plans
cover BOTOX® under the medical benefit and others cover BOTOX®
under the pharmacy benefit. To find out how BOTOX® is covered
under your insurance plan, call the BOTOX ADVANTAGETM Program Reimbursement
Hotline, toll-free, at 1-800-530-6680. Our knowledgeable Hotline
staff is available to assist you with your insurance coverage questions
Monday through Friday from 8:00 am to 6:00 pm ET.
Additionally, Hotline
representatives will help physicians and patients research alternative
coverage for those who do not have insurance or cannot qualify for
government assistance. If the Hotline representatives cannot find
alternative coverage, they will help determine if patients meet
the criteria for the BOTOX® Patient Assistance Program. The
BOTOX® Patient Assistance Program is available to all patients
who lack insurance coverage and demonstrate financial need.
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Where
can I learn more about Blepharospasm and Cervical Dystonia?
Speaking with one of
our physicians is the best source of information about your condition
and its treatment. However, there are several organizations that
you may also find helpful:
Benign Essential Blepharospasm
Research Foundation (BEBRF)
(409) 832-0788
www.blepharospasm.org
Dystonia Medical Research
Foundation (DMRF)
(312) 755-0198 • (800) 377-DYST
www.dystonia-foundation.org
ST/Dystonia, Inc.
(262) 560-9534 • (888) 445-4588
www.spasmodictorticollis.org
The National Spasmodic
Torticollis Association (NSTA)
(714) 378-7837 • (800) 487-8385
www.torticollis.org
WE MOVE--Worldwide Education
and Awareness for Movement Disorders
(800) 437-MOV2
www.wemove.org
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