Summary of Information about BOTOX ®( onabotulinumtoxinA)
What is the most important information I should know about BOTOX ®?
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, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
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.
BOTOX ® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX ®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
BOTOX ® dosing units are not the same as, or comparable to, any other botulinum toxin product.
What is BOTOX ®?
BOTOX ® is prescription medicine a medical professional injects into muscles 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 and older.
It is not known whether BOTOX ® is safe or effective to prevent headaches in people with migraine who have 14 or fewer headache days each month( episodic migraine).
Who should not take BOTOX ®?
Do not use BOTOX ® if you are: allergic to any of the ingredients in BOTOX ® such as botulinum toxin type A and human serum albumin; had an allergic reaction to another botulinum toxin product such as Myobloc ®( rimabotulinumtoxinB), Dysport ®( abobotulinumtoxinA), or Xeomin ®( incobotulinumtoxinA); or have a skin infection at the planned injection site.
What should I tell my doctor before treatment?
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis( Lou Gehrig’ s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects.
Tell your doctor if you have or have had breathing problems such as asthma or emphysema; swallowing problems; bleeding issues; plan to or have had surgery; have forehead muscle weakness such as trouble raising your eyebrows; drooping eyelids; or any changes to your face.
Tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding or plan to breast feed. It is not known if BOTOX ®( onabotulinumtoxinA) can harm your unborn baby or if BOTOX ® passes into breast milk.
What Are Common Side Effects?
The most common side effects include neck pain; headache; migraine; slight or partial facial paralysis; eyelid drooping; bronchitis; musculoskeletal stiffness; muscular weakness; pain in 1 or more muscles, ligaments, tendons, or bones; muscle spasms; injection site pain; and high blood pressure. Other side effects have been reported including allergic reactions e. g. itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint.
These are not all of the possible side effects. Call your doctor for medical advice if you experience any side effects after treatment with BOTOX ®.
What Should I Tell My Doctor About Medicines and Vitamins I Take?
Using BOTOX ® with certain 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. Tell your doctor if you have received an injection with another botulinum toxin product in the last 4 months, such as Myobloc ®, Dysport ®, or Xeomin ®. Be sure your doctor knows which product you received.
Tell your doctor about all prescription and overthe-counter medicines and supplements you take including: vitamins and herbal products; recent antibiotic injections; anticholinergics; muscle relaxants; allergy or cold medicine; sleep medicine; aspirin-like products; and blood thinners. Ask your doctor if you are not sure whether your medicine is listed above.
To Learn More
If you would like more information, talk to your doctor and / or go to BotoxChronicMigraine. com for full Product Information.
You may report side effects to the FDA at www. fda. gov / medwatch or call 1-800-FDA-1088.
Based on 72511US15 Rev. 01 / 2016 APC05FR16
© 2016 Allergan. All rights reserved. ® marks owned by Allergan, Inc. Patented. See: www. allergan. com / products / patent _ notices Myobloc ® is a registered trademark of Solstice Neurosciences, Inc. Dysport ® is a registered trademark of Ipsen Biopharm Limited Company. Xeomin ® is a registered trademark of Merz Pharma GmbH & Co KGaA
12 HeadWise ® | Volume 6, Issue 3 • 2017