BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indication
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).
IMPORTANT SAFETY INFORMATION
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® 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
The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect
when BOTOX® Cosmetic has been used at the recommended dose to treat
frown lines.
Serious and/or immediate allergic reactions have been reported.
They 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 are wheezing or
have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to
any of the ingredients in BOTOX® Cosmetic (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.
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® Cosmetic.
Tell your doctor about all your medical conditions, including:
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® Cosmetic
can harm your unborn baby); are breast-feeding or plan to breast-feed
(it is not known if BOTOX® Cosmetic passes into breast milk).
Human albumin and spread of viral diseases. 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 the medicines you take,
including prescription and nonprescription medicines, vitamins, and
herbal products. Using 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® 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; or take a sleep medicine.
Other side effects of 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.
Please see BOTOX® Cosmetic full
Product Information, including
Medication Guide.
