Indications
BOTOX
® (onabotulinumtoxinA) 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 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, and finger muscles in people 18
years and older with upper 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
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
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®
and 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 (dysphonia), trouble saying words clearly (dysarthria),
loss of bladder control, trouble breathing, trouble swallowing. If this happens,
do not drive a car, operate machinery, or do other dangerous activities
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.
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.
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 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, 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 or for detrusor overactivity associated with a neurologic condition.
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.
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® Units compared with
placebo (1.5% versus 0.4%, respectively).
Human albumin and spread of viral diseases. BOTOX® and BOTOX® Cosmetic
contains albumin, a protein component of human blood. The potential risk of spreading
viral diseases (eg, Creutzfeldt-Jakob disease [CJD]) via human serum albumin is
extremely rare. No cases of viral diseases or CJD have ever been reported in association
with human serum albumin.
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;
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.