BOTOX® belongs to a class of
drugs called botulinum toxins. BOTOX®, a focal agent intended to reduce
muscle contraction, is the brand of botulinum toxin type A made by
Allergan. BOTOX® is the most studied brand of botulinum toxins and has
been helping patients worldwide for more than 15 years.
This section is designed to help you understand the way BOTOX® works,
its effectiveness, and its side effects. The potential of BOTOX® for
continued use is also discussed. You may find it helpful to bookmark
this site for future reference.
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
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.
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.
Important Safety Information
BOTOX® treatment is contraindicated in the presence of infection at
the proposed injection site(s) and in individuals with known
hypersensitivity to any ingredient in the formulation. Serious and/or
immediate hypersensitivity reactions have been rarely reported. These
reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea.
If such a reaction occurs, further BOTOX® injection should be
discontinued and appropriate medical therapy immediately instituted.
BOTOX® should only be diluted with 0.9% non-preserved sodium chloride.
Other diluents, including lidocaine should not be used for
reconstitution. Individuals with peripheral motor neuropathic diseases (eg,
amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular
junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome)
should only receive BOTOX® treatment with caution.
The most frequently reported adverse reactions in patients with
cervical dystonia are dysphagia (19%), upper respiratory infection
(12%), neck pain (11%), and headache (11%). The most frequently reported
treatment-related adverse reactions in blepharospasm patients are ptosis
(20.8%), superficial punctate keratitis (6.3%), and eye dryness (6.3%).
No. BOTOX® has been used for more than 15 years to help patients
worldwide, and it is approved by the health ministries of at least 70
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
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.
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
BOTOX® blocks the nerve from releasing acetylcholine. As a result,
the muscle spasms stop or are greatly reduced, providing relief from
symptoms. Your healthcare 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.
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 15 years to help 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:
- Changes in your condition - If the pattern of your muscle
activity changes, your healthcare 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
Because botulinum toxins are usually used to treat chronic
conditions, it's important to preserve responsiveness to therapy.
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
BOTOX® is injected into the affected muscle(s). Your doctor will
determine which muscles need to be treated.
Some people report 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 2 weeks of the injection. If you're receiving BOTOX®
for blepharospasm, you'll usually see effects within 3 days.
BOTOX® offers sustained relief, dose after dose. The relief you'll
feel from 1 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 4 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®.
The most frequently reported adverse reactions in
patients receiving BOTOX® for the treatment of cervical dystonia are
dysphagia (difficulty swallowing, 19%), upper respiratory infection
(such as a cold or flu,12%), neck pain (11%), and headache (11%).
Dysphagia is a commonly reported adverse event following treatment of
cervical dystonia patients. In these patients, there are reports of rare
cases of dysphagia serious enough to require the insertion of a gastric
feeding tube (a tube for introducing nutritious, high-calorie fluids
into the stomach).
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.
Please seek immediate medical attention if swallowing, speech, or
respiratory (breathing) disorders arise.
Your healthcare provider can help you decide if BOTOX® is right for
you. In order to make the right treatment decision, you should discuss
the following with your healthcare provider before choosing treatment:
- Clinical experience with the drug
- Effectiveness and side effects
Make sure your healthcare 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 healthcare provider about any prescription or
over-the-counter medications you are taking before receiving BOTOX®.
The BOTOX ADVANTAGE® 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
healthcare 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 ADVANTAGE® 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.