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
170767 _ LOT A _ NHF Feb 2017 Vol . 6 Issue 3 . indd 12 2 / 15 / 17 12:48 AM