What is BOTOX®?
You may have heard of BOTOX® Cosmetic. But as you will learn in this brochure, the BOTOX® story is more than skin deep.
BOTOX (Botulinum Toxin Type A) is an effective therapy that has been used to treat patients for a variety of conditions for more than 18.years. It is one of the most researched medicines in the world. First identified in the 1890s, BOTOX® is a purified protein that comes from the bacterium Clostridium botulinum. In
slightly more than 100 years, our knowledge of botulinum toxin type A has expanded from the identification of the bacterium C. botulinum if the commercialization of botulinum toxin type A, as BOTOX® therapy.
In 1989, BOTOX® neurotoxin was approved by the Food and Drug Administration (FDA) for the treatment of blepharospasm (eyelid spasms) and strabismus (crossed or misaligned eyes). In 2000, the FDA approved BOTOX® for the treatment of uncontrollable muscle tightening or turning in the neck, known as cervical dystonia.
Another milestone in the history of BOTOX® was its approval in 2004 to treat severe underarm sweating that is not adequately managed with topical agents. The same formulation used to treat frown lines between the brows for people ages 18 to 65 was approved in 2002 as BOTOX® Cosmetic.
BOTOX is approved 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 severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 to 65.
How BOTOX® neurotoxin treatment works
When you experience the muscle spasms associated with blepharospasm. it is because your nerve cells are sending signals directly to your muscles. BOTOX® (Botulinum Toxin Type A) treatment works by blocking these signals. which prevents the release of a substance known as acetyl/choline. Too much acetylcholine causes your muscles to become overactive and tense up. With BOTOX muscle spasms may stop or become greatly reduced, resulting in relief. Please discuss with your doctor any questions you may have about your treatment.
BOTOX® is approved for the treatment of strabismus (crossed eyes) and blepharospasm (eyelid spasms) associated with dystonia (muscle tightening). including benign essential bepharospasm or VU nerve disorders in patients 12 years of age and above. The efficacy of BOTOX® treatment in deviations over
50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOIDX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.
What to expect from your BOTOX® treatment
Once you and your doctor have determined that BOTOX® (Botulilium Toxin Type A) is right for you, your treatment will consist of a number of injections into the muscles selected by your doctor. BOTOX® injections will be given right in your doctor’s office. The amount of BOTOX® and the locations of the injections will depend on your individual needs. You may have mild and temporary pain, tenderness, and/or bruising at the injection sites. Because BOTOX® neurotoxin is injected directly into your affected muscles, it is not expected to be present in your bloodstream after injection at the recommended dosage. You should be able to leave your doctor’s office after a brief recovery period.
How long does it take to see results? Not long at all. You may begin seeing an improvement in your symptoms within a few days of BOTOX® treatment, and you may not have to visit your doctor for another injection for up to 3 months.
Important Safety Information Warnings: Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an
allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking, or breathing, call your doctor immediately. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX® and BOTOX- Cosmetic. Dysphagia (difficulty swallowing) is a commonly reported adverse event fortowing treatment of cervical dystonia patients with au botuUnum toxins. In these patients, there are reports of rare cases of dysphagia sever enough to warrant the insertion of a gastric feeding tube. Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech or respiratory disorders arise.
Frequently Asked Questions about BOTOX® treatment
Does BOTOX® treatments hurt?
The needles used to administer BOTOX® (Botulinum Toxin Type A) treatment are very fine, so most people experience only mild discomfort. It is uncommon for pain relief to be required, although some doctors suggest the use of a topical anesthetic cream before treatment.
Is BOTOX® Cosmetic the same as BOTOX®?
Yes. BOTOX® Cosmetic and BOTOX® are the same formulation. BOTOX® neurotoxin is one of the most widely researched medicines in the world and has been used for more than 18 years to effectively treat a variety of medical conditions. The same formulation with dosing specific to glabellar lines (frown lines between the brows) for people ages 18 to 65 was approved in 2002 as BOTOX® Cosmetic.
Is it safe to get repeated injections of BOTOX®?
BOTOX® treatment is FDA approved for repeat injections. Patients around the world receive repeated injections of BOTOX® neurotoxin to effectively treat a variety of medical conditions.
Are there other treatments that are as effective as BOTOX® treatment?
BOTOX® is different from other therapies available to your physician. It has a unique formulation and mechanism of action that effectively stop muscle contractions in blepharospasm patients.
Is it true that some patients do not always have the same response to repeated BOTOX® injections?
There are many factors that impact the results of BOTOX® treatment. A very small percentage of people develop immunity to BOTOX Other factors that impact results include the accuracy of injections, dosing, and changes in patients’ conditions over time.
How do I know that I am receiving BOTOX® treatment and not a substitute product?
BOTOX® is a registered trademark of Allergan, Inc. The BOTOX® product is packaged in a glass vial with a purple lid labeled as BOTOX® and has an Allergan hologram on the side. You may want to ask your injector to see the vial to confirm that this is the product he or she is using for your treatment.
Important Safety lnformation
Side effects: Localized pain, tenderness and/or bruising may be associated with the injection.
In cervical dystonia the most common side effect following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%) and headache (11%).
BOTULINUM TOXIN, TYPE A POST TREATMENT INSTRUCTIONS
- Avoid lying down for several hours following treatment.
- Facial exercise in the area of treatment is recommended [frown/smile 1 hour].
- Avoid manipulation of the area the first four-hours after procedure.
Note: These measures should minimize the possibility of ptosis.
- Treatment effect may take 3-8 days to appear.
- The benefits may last 3-6 months. the average is 4 months.
- A touch-up may be necessary in 1-2 weeks.
- Contact the practitioner as soon as possible after the eight [8th] day if you have not received the desired effect.