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BOTOX® Cosmetic Product InformationBOTOX® Product InformationMedication GuideFor
Healthcare Professionals:BOTOX® Medical |BOTOX® Cosmetic
BOTOX® Cosmetic
Product Information
BOTOX®
Product Information
Medication
Guide



BOTOX® IS USED FOR BOTH AESTHETIC AND THERAPEUTIC TREATMENTS. LEARN MORE ABOUT
HOW BOTOX® CAN WORK FOR YOU.


AN FDA-APPROVED AESTHETIC PRODUCT THAT TEMPORARILY MAKES MODERATE TO SEVERE
FROWN LINES, CROW'S FEET, AND FOREHEAD LINES LOOK BETTER IN ADULTS.

VISIT SITE

Actual patients. Results may vary.


ASK YOUR DOCTOR ABOUT PRESCRIBING BOTOX® FOR THERAPEUTIC TREATMENT OF MEDICAL
CONDITIONS. BOTOX® CAN PROVIDE TEMPORARY TREATMENT OF THE BELOW CONDITIONS.

Chronic Migraine


Adult Spasticity
(Muscle stiffness in arms and legs)

Pediatric Spasticity
(Muscle stiffness in arms and legs for children 2 to 17 years of age)

Cervical Dystonia
(Abnormal neck position)

Overactive Bladder


Overactive Bladder
(Due to a neurologic condition)

Severe Primary Axillary Hyperhidrosis
(Severe underarm sweating)

Blepharospasm
(Eyelid spasm)

Strabismus
(Eye muscle alignment)


See below for full Indications and Important Limitations

Learn how to save on out-of-pocket costs

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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:



Expand +
 * 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 preexisting 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;
   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.

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

 * 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 caused by a neurologic disease who still have leakage or
   cannot tolerate the side effects after trying an anticholinergic medication
 * To treat overactive bladder due to a neurologic disease in children 5 years
   of age and older when another type of medicine (anticholinergic) does not
   work well enough or cannot be taken
 * 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 people 2 years of age and older with
   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 of age 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 and effective to
prevent headaches in patients with migraine who have 14 or fewer headache days
each month (episodic migraine).

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.

It is not known whether BOTOX® and BOTOX® Cosmetic are safe and effective 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.



IMPORTANT SAFETY INFORMATION (continued)

BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle
weakness, vision problems, or dizziness within hours to weeks of receiving
BOTOX® or 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 (difficulty
fully emptying the bladder), only patients who are willing and able to initiate
catheterization posttreatment, 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. The median duration of
postinjection catheterization for these patients treated with BOTOX® 100 Units
(n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a
median duration of 11 days (minimum 3 days to maximum 18 days) for patients
receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX®
were more likely to develop urinary retention than nondiabetics.

Adult patients treated for overactive bladder due to neurologic disease: In
clinical trials, 30.6% of adult 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
postinjection 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 adult 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, 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 adults receiving BOTOX® for
upper limb spasticity. Upper respiratory infections were also reported more
frequently in adults with prior breathing-related problems with spasticity. In
pediatric patients treated with BOTOX® for upper limb spasticity, upper
respiratory tract infections were reported more frequently. In pediatric
patients treated with BOTOX® for lower limb spasticity, upper respiratory tract
infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to a
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 adult
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; have weakness of forehead muscles, trouble raising your eyebrows, drooping
eyelids, and 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 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.

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 by injection; take muscle
relaxants; take an allergy or cold medicine; take a sleep medicine; take
aspirin-like products or blood thinners.

Other side effects of BOTOX® and BOTOX® Cosmetic include dry mouth, discomfort
or pain at the injection site; tiredness; headache; neck pain; eye problems such
as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling
of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract
infection. In adults being treated for urinary incontinence, other side effects
include urinary tract infection and painful urination. In children being treated
for urinary incontinence, other side effects include urinary tract infection and
bacteria in the urine. If you have difficulty fully emptying your bladder on
your own 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.

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BOTOX® and its design are registered trademarks of Allergan, Inc., an AbbVie
company.
© 2021 AbbVie. All rights reserved.
MBD72066-v9 04/21

Reference: 1. American Optometric Association. Optometric Clinical Practice
Guideline: Care of the Patient with Strabismus: Esotropia and Exotropia. St.
Louis, MO. 1995:9.

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