Full BOTOX® Product Information Including Boxed Warning | Medication Guide | Full BOTOX® Cosmetic Product Information including Boxed Warning
Important Safety Information including Boxed Warning                                                    For Health Care Professionals: Botox® Medical | Botox® Cosmetic

BOTOX® (onabotulinumtoxinA)

Please See Below for Full Indications and Important Limitations.

  • Blepharospasm and Strabismus

  • Cervical Dystonia

  • Chronic Migraine

  • Overactive Bladder

  • Severe Underarm Sweating When Antiperspirants Fail

  • Upper Limb Spasticity

BOTOX® Cosmetic (onabotulinumtoxinA)

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

Eight out of ten women achieved clinically significant results at day 30 in clinical trials.1 Results may vary.

Please see below for Important Safety Information.

ACTUAL UNRETOUCHED PHOTO OF
REAL BOTOX® COSMETIC USER.

BOTOX® has been used to effectively treat blepharospasm and strabismus for more than 20 years1

BOTOX® is a prescription medicine that is injected into muscles and used to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.

Blepharospasm (BLEH-far-o-spaz-em) is a muscle disorder that causes involuntary spasms of the muscles around your eye.2-4 Strabismus (STRE-bis-mes) is a disorder that causes the eyes to misalign, commonly known as “crossed eyes.”5

If you are affected by either of these eye muscle disorders, talk to your doctor about BOTOX® therapy.

Cervical Dystonia may be treated effectively with BOTOX® therapy

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.

Neck pain and muscle spasms are in fact among the most common symptoms of cervical dystonia, a disorder of the nerves that causes muscles to contract and spasm on their own.1,2

Learn more about signs, causes, and the treatment of BOTOX® for cervical dystonia.

For people with Chronic Migraine, BOTOX® is proven to significantly reduce headache days each month

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® neurotoxin is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX® prevents up to 9 headache days a month (versus up to 7 in placebo) and is injected every 3 months by your doctor—there is no daily treatment.1

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.

BOTOX® treatment for Upper Limb Spasticity (elbow, wrist, and fingers)

BOTOX® is a prescription medicine that is injected into muscles and used to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb 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, and fingers, or to treat increased stiffness in lower-limb muscles. 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 your existing physical therapy or other rehabilitation that your doctor may have prescribed.

BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic 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® or BOTOX® Cosmetic:

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

Indications

BOTOX® is a prescription medicine that is injected into muscles and used:

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 improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).

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, and fingers, or to treat increased stiffness in lower-limb muscles. 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 your existing physical therapy or other rehabilitation that your doctor may have prescribed.

It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION (continued)

Do not take BOTOX® or BOTOX® Cosmetic 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® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not take 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, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for these patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.

Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.

The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported. These reactions 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 experience any such symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.

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® or BOTOX® Cosmetic.

Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for upper limb spasticity. The risk of pulmonary effects in patients with compromised respiratory status 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 their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.

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, such as 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 breastfeed (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 nonprescription medicines, vitamins, and herbal products. Using BOTOX® or BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® or BOTOX® Cosmetic in the past.

Especially 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 (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).

Other side effects of BOTOX® and BOTOX® Cosmetic 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. 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.

Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.

 

® marks owned by Allergan, Inc. APC05UE13

Dysport is a registered trademark of Ipsen Biopharm Limited.
Myobloc is a registered trademark of Solstice Neurosciences, Inc.
Xeomin is a registered trademark of Merz Pharma GmbH & Co. KGaA.

Reference: 1. BOTOX® Cosmetic Prescribing Information, Carruthers.

Reference: 1. BOTOX® Prescribing Information, January 2013. 2. Malinovsky V. Benign essential blepharospasm. J Am Optom Assoc. 1987;58(8):646-651. 3. Grandas F, Elston J, Quinn N, Marsden CD. Blepharospasm: a review of 264 patients. J Neurol Neurosurg Psychiatry. 1988;51(6):767-772. 4. Hallett M, Daroff RB. Blepharospasm: report of a workshop. Neurology. 1996;46(5):1213-1218. 5. The American Association for Pediatric Ophthalmology and Strabismus. Adult strabismus general information. The American Association for Pediatric Ophthalmology and Strabismus website. http://www.aapos.org/terms/terms/120. Accessed June 4, 2012.

Reference: 1. Galvez-Jimenez N, Lampuri C, Patino-Picirrillo R, Hargreave MJA, Hanson MR. Dystonia and headaches: clinical features and response to botulinum toxin therapy. In: Fahn S, Hallett M, DeLong MR, eds. Dystonia 4: Advances in Neurology. Philadelphia, PA: Lippincott Williams & Wilkins; 2004;94:321-328. 2. Jankovic J. Treatment of cervical dystonia. In: Brin MF, Comella CL, Jankovic J, eds. Dystonia: Etiology, Clinical Features, and Treatment. Philadelphia, PA: Lippincott Williams & Wilkins; 2004:159-166.

Reference: 1. BOTOX® Prescribing Information, January 2013.

Reference: 1. Lear W, Keesler E, Solish N, Glaser DA. An epidemiological study of hyperhidrosis. Dermatol Surg. 2007;33(1 Spec No.):S69-S75.

 

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