BOTOX® (onabotulinumtoxinA)
Clinical use of BOTOX® is the result of more than 100 years of study into botulinum toxin type A. BOTOX® is one of the world's most versatile and widely-researched medicines. BOTOX® is one of the world's most versatile and widely-researched medicines with approximately 2000 publications in peer-reviewed scientific and medical journals. BOTOX® is currently approved in approximately 75 countries, bettering the lives of patients suffering from such serious or debilitating conditions as cervical dystonia, blepharospasm, strabismus and symptoms of severe primary axillary hyperhidrosis (excessive underarm sweating) when medicines on the skin (topical) do not work well enough. Millions of patients worldwide have been treated therapeutically with BOTOX® over the course of nearly 20 years, and Allergan is honoring its commitment to these patients through the provision of quality product, patient and physician education, and the continued pursuit of novel neurotoxin-based therapeutics. In the United States, BOTOX® is current being investigated for the treatment of other medical conditions.
BOTOX® is a purified protein that works by blocking overactive nerve impulses that trigger excessive muscle contractions or glandular activity. The effect is temporary and lasts from approximately one to six months, depending on the individual patient and indication. BOTOX® therapy should only be administered by a trained and qualified physician. Approved therapeutic indications for BOTOX® in the United States include the following:
Blepharospasm
Patients with blepharospasm experience an involuntary clenching of the muscles that control the eyelid, causing uncontrollable blinking that generally affects both eyes. In severe cases, blepharospasm can force the eye closed and result in functional blindness. Blepharospasm affects approximately 25,000 people in the United States.1 In 1989, the U.S. Food and Drug Administration (FDA) approved BOTOX® neurotoxin for the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in adults and children 12 years of age and older. Therapy with BOTOX® is a generally accepted standard of care for blepharospasm, and involves the injection of small therapeutic doses directly in the affected muscles around the eye to relieve the excessive muscle contractions.
Cervical Dystonia
Cervical dystonia, also called spasmodic torticollis, is characterized by involuntary contractions of the neck muscles that cause twisting, repetitive movements, or abnormal postures of the head. The muscle contractions hinder normal movement and can cause severe, chronic neck pain. Cervical dystonia belongs to a group of movement disorders collectively known as "focal dystonias," that affect more than 300,000 people in North America.2 While awareness of this condition is extremely limited, cervical dystonia is the third most common movement disorder, after Parkinson's disease and tremor,3 affecting approximately 125,000 people in the United States.4 BOTOX® received approval from the FDA in 2000 for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
Severe Primary Axillary Hyperhidrosis
Hyperhidrosis is the medical term for excessive sweating, which is a common chronic condition affecting an estimated 7.8 million people in the United States.5 Hyperhidrosis can cause dehydration and skin problems. Patients with hyperhidrosis produce an amount of sweat that far exceeds that needed to regulate body temperature. BOTOX® was approved by the FDA in 2004 for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with topical agents. BOTOX® therapy is administered through tiny injections into the underarms to inhibit the release of a neurotransmitter, acetylcholine, from nerve cells, blocking the signals that stimulate the eccrine glands to produce sweat.
Strabismus
Strabismus (crossed eyes) is a visual defect that results when the eyes do not properly align with each other. It is caused by weakness or other problems with one or more of the muscles surrounding each eye that coordinate eye movement and position the eyes to focus in the same direction. Strabismus usually develops during childhood, but can occur at any age and may affect between 5 and 15 million people in the United States.6 The misalignment of the eye may be constant, or may come and go, but does not often resolve without medical intervention. Left untreated, strabismus can result in serious vision problems. In 1989, the FDA granted approval of BOTOX® for strabismus associated with dystonia in patients 12 years of age and older. Therapy with BOTOX® neurotoxin involves the injection of small therapeutic doses directly into the muscles surrounding the eye and provides a minimally-invasive alternative to surgery for selected strabismus patients.
Indication
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.
Important Safety Information
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX®:
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Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of BOTOX® usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX®.
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Swallowing problems may last for several months. People who already have swallowing or breathing problems before receiving BOTOX® have the highest risk of getting these problems.
- Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing.
These symptoms can happen hours to weeks after you receive an injection of BOTOX®.
These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving BOTOX®" in Medication Guide.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat severe underarm sweating, blepharospasm, or strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
Tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.
BOTOX® can cause serious side effects. Other side effects of BOTOX® include:
dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. Symptoms of an allergic reaction to BOTOX® may include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of BOTOX®. For more information, ask your doctor or pharmacist.
For additional information refer to Medication Guide. This Medication Guide summarizes the most important information about BOTOX®. If you would like more information, talk with your doctor.