IMPORTANT SAFETY INFORMATION (Continued)
Do not take BOTOX® (onabotulinumtoxinA) 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.
The dose of BOTOX® 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®
should be discontinued.
JUNE
is National
Migraine and Headache
Awareness Month
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®.
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; are
pregnant or plan to become pregnant (it is not known if
BOTOX® can harm your unborn baby); are breastfeeding or
plan to breastfeed (it is not known if BOTOX® passes into
breast milk).
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and
herbal products. Using BOTOX® 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® 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®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.
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 refer to full Medication Guide including Boxed
Warning on the following pages.
For adults with Chronic Migraine,
15 or more headache days a month,
each lasting 4 hours or more,
FOR ADULTS WITH
CHRONIC MIGRAINE
BOTOX® is the first and only preventive treatment
proven to reduce headache days every month.
injection
BOTOX® is the only FDA-approved, preventive treatment that is
injected by a doctor every 3 months for people with Chronic Migraine.
BOTOX® prevents up to 9 headache days a month, versus up to 7 days
for placebo. BOTOX® is not approved for adults with migraine who
have 14 or fewer headache days a month.
Find a headache specialist near you at
BotoxChronicMigraine.com
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).
IMPORTANT SAFETY INFORMATION
BOTOX® 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®:
• 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 injec F