
BOTOX® belongs to a class of drugs called botulinum toxins. BOTOX®, a
focal muscle-relaxing agent, is the brand of botulinum toxin type A made by Allergan.
BOTOX® is the most studied brand of botulinum toxins and has been used to
treat over one million patients worldwide for more than 11 years.
The following
represent questions frequently asked by your patients.
BOTOX® is indicated
for the treatment of cervical dystonia in adults to decrease the severity of
abnormal head position and neck pain associated with cervical dystonia.
BOTOX® is
indicated for the treatment of strabismus and blepharospasm associated with dystonia,
including benign essential blepharospasm or VII nerve disorders in patients 12
years of age and above.

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.

No. BOTOX® has been used for more than 11 years to treat over one million patients
worldwide, and it is approved by the health ministries of at least 70 countries.

BOTOX® is Allergan’s brand of botulinum toxin type A. A brand of botulinum
toxin type B is also now available. The two toxins are different in several ways:
- They
are different serotypes
- They have different manufacturing processes
- They
work differently
- They require different doses
BOTOX® differs from oral therapies in that it is a non-systemic, focal therapy.
When drugs are taken orally, they are distributed throughout the body by the
blood system. The drugs reach not only their desired site of action but also
many additional sites. In contrast, BOTOX® is administered directly into
the desired site of action. BOTOX® is not expected to be present in the blood
stream at measurable levels following injection at the recommended doses.
BOTOX® provides targeted relief of symptoms for the treatment of neck pain
and abnormal head position in cervical dystonia with
- No GI upset
- No
fatigue
- No confusion
- No depression
- No liver toxicity
BOTOX® has been proven as a safe and effective therapy, and has been widely
used for more than 11 years.
Over the past 20 years, BOTOX® has been evaluated
in more than 200 studies specific to approved indications in the U.S. Currently,
little clinical data are published about botulinum toxin type B.
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 prolonged relief from symptoms. Your health care provider will address
how much BOTOX® is needed to treat you optimally.
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 three 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 adequate clinical response was obtained.

Each treatment typically lasts three 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 one million patients worldwide, and although formal, long-term
clinical evaluations have not been conducted, its safety for long term use is supported by the reported and continuing studies conducted to date as well as by years of successful clinical experience.
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:
- 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.
- 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.
- 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.
BOTOX® is injected into the affected muscle(s). Your doctor will determine
which muscles need to be treated.
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.
If you’re receiving BOTOX® for cervical dystonia, you’ll usually
see the effects within two weeks of the injection. If you’re receiving BOTOX® for
blepharospasm, you’ll usually see effects within three days.
BOTOX® generally offers sustained relief, dose after dose. The relief you’ll
feel from one treatment of BOTOX® will normally last for about three 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®.
You and your healthcare provider mutually will decide if Botox® is the appropriate therapy for you.
In order to make the right treatment decision, you should discuss the following
with your health care provider before choosing treatment:
- Clinical experience
with the drug
- Effectiveness and side effects
Make sure your health care
provider knows if you are pregnant, nursing, or taking any medications before
receiving BOTOX® injections. Additionally, you should not receive BOTOX® if
you have an infection at the injection site. BOTOX® should be used with caution
if you have other neurological diseases or disorders, or if you are taking aminoglycoside
antibiotics or other drugs that interfere with neuromuscular transmission. Be
sure to tell your health care provider about any prescription or over-the-counter
medications you are taking before receiving BOTOX®.
Your health care provider 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
For more information on BOTOX® contact us through this Web site:
Contact Us
or
call 1-800-44-BOTOX®