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).
Whether you’re considering BOTOX® treatment, or have already received treatment, here’s what you need to know.
Your first treatment
For Chronic Migraine patients, the FDA has approved a specific dose and injection pattern for BOTOX® treatment—31 injections are given over 7 key areas of the head and neck once every 12 weeks to prevent headache days.
Here’s what to expect during your first treatment:
- Injections to 7 key areas of the head and neck
- Very fine needles are used for 31 total injections
- Injections feel like tiny pinpricks—you may feel 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)
- 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
- 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 side of the head.
When to expect results
In clinical trials, BOTOX® provided a significant reduction in headache days after the first treatment. After the second treatment (at 24 weeks), BOTOX® prevented up to 9 headache days a month (vs up to 7 with placebo injection).
Why commit to 2 treatments?
Committing to 2 treatment sessions is important in order to see how BOTOX® is working for you, since BOTOX® showed significant reduction in headache days at 24 weeks. Talk to your doctor about your progress, and as you start to see changes in the amount of headache days you’re having each month, keep track with your headache diary.
What happens next: a 12-week treatment schedule
Based on your progress, you and your doctor will discuss re-treatment every 12 weeks. Remember: BOTOX® is a preventive treatment, which means it’s taken to prevent headaches and migraines from occurring. So, it is recommended that treatment be given once every 12 weeks.
The best way for you and your doctor to know if BOTOX® is meeting your treatment needs is to give it time to work, so talk to your doctor, and stay on track.
Ways to stay on track
Want to make sure you stay on schedule? Make your next appointment right after each treatment session—before you leave the office—so you don’t forget.
Feeling your progress is one thing, seeing it on paper is another. As you begin to have fewer headache days, use your headache diary to track your progress, and see how far you’ve come!
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 asMyobloc®(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 asMyobloc®, 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 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.
- BOTOX® (onabotulinumtoxinA) Prescribing Information, February 2014.
®marks owned by Allergan, Inc. APC18GH14
With the BOTOX® Savings Card you can get up to $100 per treatment (new patients get up to $250 for each of their first 2 treatments) to help with out-of-pocket costs not covered by your insurance. The BOTOX® Savings Card can be used for up to 4 treatments and/or related procedures in a 12-month period.
Card Usage Language
Your BOTOX® Savings Card may only be used at hospitals, physician offices, and pharmacies, and will not be accepted at any other location that normally accepts Visa® Debit cards. The BOTOX® Savings Card cannot be used at merchants outside the United States (including Internet and mail/telephone merchants).
The BOTOX® Savings Card is issued by Metropolitan Commercial Bank, member FDIC, pursuant to license by Visa USA, Inc. “Metropolitan Commercial Bank” and “Metropolitan” are registered trademarks of Metropolitan Commercial Bank © 2014. See the Cardholder Agreement for Terms and Conditions. By accepting, signing, or using this savings card, you agree to the Terms and Conditions of the Cardholder Agreement. This savings card will remain the property of the issuing institution and the privilege of its use may be withdrawn at any time.
TERMS AND CONDITIONS
By participating, you understand and agree to comply with the Program rules as set forth below.
Offer is valid only for BOTOX® and BOTOX® treatment-related costs not covered by your insurance plan. The BOTOX® Savings Card will be funded upon approval of your claim. Your claim must be submitted with your Explanation of Benefits (EOB) or your Specialty Pharmacy Provider (SPP) receipt. (If your BOTOX® prescription was filled by a Specialty Pharmacy Provider, you must send both your EOB and SPP receipt.)
All claims must be submitted within 90 days of the date of service listed on the EOB. BOTOX® Savings Card may not be combined with any other offer or discount. This BOTOX® Savings Card is not health insurance.
Offer not valid for patients participating in Medicare, Medicaid, or any similar federal or state healthcare program, including any state medical or pharmaceutical assistance programs. If patients are eligible for drug benefits under any such program, they cannot use this BOTOX® Savings Card.
Offer void where prohibited by law, taxed, or restricted. Offer good only in the United States. Allergan, Inc., reserves the right to rescind, revoke, and amend this offer without notice.
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.
Metropolitan Commercial Bank and Metropolitan are registered trademarks of Metropolitan Commercial Bank.
Visa is a registered trademark of Visa International Service Association.