BOTOX, a focal agent















BOTOX > Consumer Connection > FAQ home | find | contact | help 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 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. 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 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 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 tense up. click to enlarge 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. click to enlarge 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 treatment. 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 between injections. 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. Your healthcare 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 File Type: pdf File Size: 659 KB Patient Brochure Click here to download the Frequently Asked Questions in PDF format. Portable Document Format(.pdf) files require the latest version of the free Adobe Acrobat Reader?. Get the Acrobat plug-in. References: 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. 2005 ALLERGAN | Terms of Use | PrescribingInformation | Privacy The information on this site is intended for US residents only.



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