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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 blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in people 12 years of age and above. BOTOX® is also indicated as a treatment to reduce wrinkles around the eyes
The most frequently reported adverse reactions during the FDA clinical trials in patients with blepharospasm are drooping of the eyelid (21%), superficial punctate keratitis (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
1. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: the clinical usefulness of botulinum toxin-A in treating neurologic disorders. Neurology. 1990;40:497-501.
2. US Dept of Health and Human Services. Botulinum Toxin. Consensus Statement. NIH Consensus Development Conference; November 12-14, 1990. Bethesda, Md: National Institutes of Health; 1990.
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How is BOTOX® different from other botulinum toxin treatments?
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
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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 ijected muscle, although some spread to the adjacent muscle may occur.
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.
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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 to 6 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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What is Blepharospasm?
Blepharospasm is a disorder of the muscles that control eyelid movement. Spasms of the eyelid lead to frequent blinking. Blepharospasm often affects both eyelids, making it difficult to open the eyelids. In severe cases, this debilitating condition can lead to what is known as "functional blindness" because the patient is unable to open or keep open the eyelids for any significant period of time.
Approximately 75% of patients with blepharospasm are female and the average age at onset is 56 years1. Although the exact cause of this disorder is unknown, experts believe that it may be caused by an inappropriate signal in the part of the brain known as the basal ganglia.2
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How is blepharospasm diagnosed?
Doctors diagnose blepharospasm based on key signs and symptoms. In the early stages of blepharospasm, patients may complain of irritation and discomfort of the eyelids as well as an increase in blinking. As the blepharospasm progresses over two years, blinking usually becomes more frequent, forceful, and uncontrollable. Bright, dazzling, or flickering lights, dusty or smoky air, or high-speed travel by train or car can make the symptoms worse. Without proper medical treatment, most patients with blepharospasm do not recover.
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How is blepharospasm treated with BOTOX®?
When injected directly in the affected eye muscles, the neurotoxin relieves the muscle spasm. Although the effect is temporary, BOTOX® can be reinjected approximately every three months as long as the patient continues to respond and does not have a serious allergic reaction.1
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulceration, especially in patients with VII nerve disorders. The effects of therapy may be increased with the use of aminoglycoside antibiotics or with other drugs that interfere with neuromuscular transmission.
The most frequently reported adverse events associated with BOTOX® include ptosis (20.8%), superficial punctate keratitis (6.3%), and eye dryness (6.3%).2 Other events reported in prior clinical studies, in decreasing order of incidence, include irritation, tearing, lagophthalmos, photophobia, entropion, keratitis, diplopia, diffuse skin rash, and local swelling of the eyelid skin lasting for several days following eyelid injection.
As with any treatment that may result in resumption of activities by previously sedentary patients, sedentary patients should be cautioned to resume activity gradually following the administration of BOTOX®.1 In general, adverse events occur within the first week following injection of BOTOX® and while generally transient may have a duration of 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.
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How long can I be treated with BOTOX®?
Each treatment typically lasts 3 to 6 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:
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.
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How can I help to 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). After a complete medical eye examination, your Vista doctor can discuss the exact placement of the injections.
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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?
You'll usually see effects within 3 to 5 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 3 to 6 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 two to 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 doctors at Vista Alliance can help you decide if BOTOX®is right for you. Make sure to tell us 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 us about any prescription or over-the-counter medications you are taking before receiving BOTOX®.
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How can I find out if my insurance covers BOTOX®?
Vista Alliance has been working closely with Allergan and their BOTOX® Program Reimbursement Hotline to helppatients get their BOTOX® reimbursements 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 for blepharospasm
Most insurance companies do not cover BOTOX® Cosmetic treatments for wrinkle reduction however we can inquire about the specific potential for benefits with your insurance plan after your consultation with one of our doctors.
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