BOTOX® (onabotulinumtoxinA)
Clinical use of BOTOX® (onabotulinumtoxinA) 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 with approximately 2000 publications in peer-reviewed scientific and medical journals. BOTOX® is currently approved in approximately 80 countries for 21 different indications to help patients worldwide suffering from such serious or debilitating conditions as cervical dystonia, blepharospasm, strabismus, increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity 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 currently 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 suffering from the condition experience an involuntary clenching of the muscles that control the eyelid, causing uncontrollable blinking which generally affects both eyes. Blepharospasm can diminish a patient's ability to perform everyday activities by interfering with their ability to see due to the lid blocking their eyes. This can progress from increased blinking to inability to open the eyelids, and finally, to functional blindness. Blepharospasm affects an estimated 20,000–50,000 people in the United States, with 2,000 new cases diagnosed annually.1 In 1989, the U.S. Food and Drug Administration (FDA) approved BOTOX® neurotoxin for the treatment of blepharospasm (abnormal spasm of the eyelids) associated with dystonia in people 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 a chronic, often painful neurological disorder. Cervical dystonia is a type of movement disorder – conditions that are characterized by loss of control over one or more parts of the body – which is estimated to affect approximately 125,000 people in the United States2, yet awareness of the condition is extremely limited. Cervical dystonia is characterized by involuntary contractions of the neck muscles that cause twisting, repetitive movements, or abnormal postures of the head. The mean age of symptom onset in patients with cervical dystonia is approximately 41 years – although it may occur in all ages – and women are twice as likely to be affected as men.3 BOTOX® (onabotulinumtoxinA) was approved by the FDA in 2000 for the treatment of the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older.
Severe Primary Axillary Hyperhidrosis
Hyperhidrosis is the medical term for severe sweating, where patients with hyperhidrosis may sweat up to four or five times more than normal, far exceeding what is needed to regulate body temperature. Severe underarm sweating may be exacerbated by stress, emotion or exercise, but often occurs spontaneously. BOTOX® injection is a minimally invasive treatment approved by the U.S. Food and Drug Administration (FDA) in 2004 to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin do not work well enough in people 18 years and older. The effects of treatment are temporary, lasting approximately 6.7 months, and treatment is often covered by insurance.4
Strabismus
Strabismus is a visual defect that results when the eyes do not properly align with each other. One eye may look straight ahead but the other may turn in (“crossed eyes”), out (“wall eyes”), upward, or downward. Strabismus usually develops during childhood but can occur at any age, affecting nearly four in every 100 adults.5 Left untreated, strabismus can result in serious vision problems.6 BOTOX® therapy was granted approval in 1989 by the U.S. Food and Drug Administration (FDA) to treat certain types of eye muscle problems (strabismus) and abnormal spasm of the eyelids (blepharospasm) in people 12 years and older. Therapy with BOTOX® provides a minimally-invasive alternative to surgery for appropriate strabismus patients and involves the injection of small therapeutic doses of purified botulinum toxin protein directly into the muscles surrounding the eye.
Upper Limb Spasticity
Spasticity is a debilitating condition impacting approximately 1 million Americans7, many of whom suffer from spasticity in the upper limbs following a stroke. Upper limb spasticity may also occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy. Although not a life-threatening condition, upper limb spasticity can be severely debilitating and painful, producing disfiguring muscle contractions that can result in stiff, tight muscles in the elbow, wrist and fingers, or a clenched fist. This stiffness hinders a patient’s ability to perform simple tasks, such as dressing or washing the hand, and often leaves the patient dependent on a caregiver to help with simple activities. In patients diagnosed with upper limb spasticity, BOTOX® is injected by a trained specialist directly into the affected muscles blocking overactive nerve impulses that trigger these disabling contractions to reduce the severity of increased muscle tone in the elbow, wrist and fingers. In clinical studies, the efficacy of BOTOX® persisted up to three months on average. BOTOX® is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity.
Indications
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat increased muscle stiffness in elbow, wrist, and finger muscles with upper limb spasticity in people 18 years and older.
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older.
- 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 in people 18 years and older.
It is not known whether BOTOX® is safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
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 any time (hours to weeks) after injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles,can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, 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.
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.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itchy rash, swelling, and shortness of breath. Tell your doctor or get medical help right away if you experience any such symptoms, further injection of BOTOX® should be discontinued.
Do not take BOTOX® if you:
are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as
Myobloc® or
Dysport®; have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (It is not known if BOTOX® can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.
BOTOX® may cause loss of strength or general muscle weakness, or vision problems. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
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.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see BOTOX® full Product Information, including Medication Guide.