Please See Below for Full Indications and Important Limitations.
BOTOX® Cosmetic (onabotulinumtoxinA)
BOTOX® Cosmetic is the only FDA-approved treatment to temporarily make moderate to severe frown lines, crow’s feet, and forehead lines look better in adults.
BOTOX® has been an effective treatment for blepharospasm since FDA approval in 1989
BOTOX® is a prescription medicine that is injected into muscles and used to treat abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.
Blepharospasm is characterized by involuntary spasms of the muscles around the eye, resulting in uncontrolled blinking, narrowing, and even closing of the eyelid.1 It is a condition that can be difficult to understand and a challenge to live with.
Abnormal head positions. Neck pain. BOTOX® may help people with
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 people 16 years and older.
Cervical dystonia is a condition that causes the muscles in your neck to tighten or spasm without your control. With cervical dystonia, your head may turn in an unusual way, or it may be forced into an abnormal, uncomfortable position. This condition can be painful and challenging.1
For people with Chronic Migraine, BOTOX® is shown to prevent headaches and migraines before they even start1-5
BOTOX® is a prescription medicine that is injected to prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
BOTOX® prevents on average 8 to 9 headache days and migraine/probable migraine days a month (vs 6 to 7 with placebo) after 2 treatments (at 24 weeks).1-5
BOTOX® for Overactive Bladder (OAB)
BOTOX® is FDA-approved to treat overactive bladder symptoms such as a strong need to urinate with leakage, urgency, and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken.
BOTOX® is a proven treatment option for severe underarm sweating when antiperspirants fail
BOTOX® treats the symptoms of severe underarm sweating when topical medicines do not work well enough in people 18 years and older. It is not known whether BOTOX® is safe or effective for severe sweating anywhere other than your armpits. BOTOX® treatments temporarily block the chemical signals from the nerves that stimulate the sweat glands, resulting in reduced sweating.
Many Americans have severe primary axillary hyperhidrosis, commonly known as severe underarm sweating, a treatable medical condition.1
Sweat is your body’s temperature regulator, but people with this condition have overactive sweat glands where the sweating significantly exceeds the body’s normal requirement for cooling.
Only a medical professional can diagnose severe underarm sweating that is not being effectively managed with clinical strength antiperspirants.
Strabismus causes the eyes to not properly align with each other. Treatment with
BOTOX® may help.
BOTOX® is a prescription medicine that is injected into muscles and used to treat certain types of eye muscle problems (strabismus) in people 12 years and older.
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 can result in serious vision problems.1
BOTOX® helps reduce stiffness in the elbow, wrist, fingers, thumb, ankle, or toes caused by Focal Spasticity.
BOTOX® is a prescription medicine that is injected into muscles to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower spasticity.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
Focal Spasticity is a condition in which certain muscles in your body become stiff or tight. It is caused by damage to parts of the central nervous system that control voluntary movements. When this happens, your nerves send continuous messages to your muscles telling them to contract, or tighten. If you or someone you care for has stiffness in the muscles of the elbow, wrist, fingers, thumb, ankle, or toes, it could be Focal Spasticity.1
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:
- 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, trouble saying words clearly, loss of bladder control, trouble breathing, and 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 chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
- to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity
- 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.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
It is not known if BOTOX® Cosmetic is safe and effective for use more than 1 time every 3 months.
BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® and BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX® or BOTOX® Cosmetic if you: are allergic to any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
Patients treated for overactive bladder
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
Patients treated for overactive bladder due to neurologic disease
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® or BOTOX® Cosmetic.
Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in people with prior breathing related problems with spasticity.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® or BOTOX® Cosmetic with certain medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you received BOTOX® or BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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.
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Reference: 1. Benign essential blepharospasm. Genetics Home Reference. http://ghr.nim.nih.gov/condition/benign-essential-blepharospasm. Reviewed May 2010. Accessed March 23, 2018.
Reference: 1. Mayo Clinic. Diseases and conditions: cervical dystonia. Mayo Clinic website. http://www.mayoclinic.org/diseases-conditions/spasmodic-torticollis/basics/causes/con-20028215?p=1. Accessed March 23, 2018.
References: 1. BOTOX® Prescribing Information, January 2016. 2. Data on file, Allergan; PREEMPT 1 Final Report. 3. Data on file, Allergan; PREEMPT 2 Final Report. 4. Data on file, Allergan; PREEMPT 1 Efficacy Data. 5. Data on file, Allergan; PREEMPT 2 Efficacy Data.
Reference: 1. Lear W, Keesler E, Solish N, Glaser DA. An epidemiological study of hyperhidrosis. Dermatol Surg. 2007;33(1 Spec No.):S69-S75.
Reference: 1. American Optometric Association. Optometric Clinical Practice Guideline: Care of the Patient with Strabismus: Esotropia and Exotropia. St. Louis, MO. 1995:9.
Reference: 1. Ivanhoe C, Elovic E. The road to rehabilitation, Part 7: Traveling toward relief: dealing with spasticity & brain injury. Brain Injury Alliance of New Jersey website. http://bianj.org/wp-content/uploads/2014/10/spasticity.pdf. Accessed March 23, 2018.
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