Getting Started

BOTOX® is injected every 12 weeks in your doctor’s office¹

“I work with needles all day long. But I myself have a bit of fear of needles.”—April, real BOTOX® patient*

Know what to expect on the day of your appointment. For Chronic Migraine patients, the FDA has approved a specific dose and injection pattern for BOTOX® treatment.

  • Injections to 7 key areas of the head and neck¹
    1. Very fine needles are used for 31 total injections
    2. Injections feel like tiny pinpricks—expect to experience mild discomfort
  • The most common side effect in Chronic Migraine clinical
    studies was neck pain experienced by 9% of BOTOX® patients
    (vs 3% in placebo)¹
    1. Other side effects include headache, migraine, slight or partial facial paralysis, eyelid drooping, bronchitis, musculoskeletal stiffness, muscle weakness, pain in 1 or more muscles, ligaments, tendons, or bones, muscle spasms, injection-site pain, and high blood pressure
    2. This does not cover all the possible serious side effects of BOTOX®. Please see the Important Safety Information including Boxed Warning and Medication Guide and talk to your doctor

BOTOX® Injection Sites

Injections are on both the right and left sides of the head.

An adequate trial is important

BOTOX® prevents up to 9 headache days a month (vs up to 7 for placebo).¹ In order to experience the full effectiveness, BOTOX® therapy requires a commitment from you and your doctor. Plan on starting with at least 2 treatment sessions (once every 12 weeks) to make sure you have an opportunity to see results.¹,² If your doctor decides that BOTOX® works for you, the recommended re-treatment schedule is every 12 weeks.

In clinical trials, BOTOX® was proven to reduce headache days after 2 treatments (at 24 weeks).¹,² Keeping a headache diary can help you and your doctor track your progress.

Make sure your next BOTOX® appointment is always scheduled before leaving your doctor’s office, as your doctor recommends.

NEXT:  Talk With Your Doctor

Indication
BOTOX® (onabotulinumtoxinA) 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 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.

Do not take BOTOX®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.

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

References:
  1. BOTOX® Prescribing Information, January 2013.
  2. Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51(9):1358-1373.

*Patient was compensated for sharing her story.

®marks owned by Allergan, Inc.   APC28BM13   133047

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.

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