2012 April Meeting MD Botox Presentation

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So, what is a Migraine
Headache?
Migraine Definition
At least 2 of the following:
• Moderate to severe pain
• One sided
• Throbbing or pulsating in character
• Worsening with movement or bending over
&
At least one of the following:
• Nausea and/or vomiting
• Sensitivity to lights, sounds or smells
Other Common Migraine Symptoms
•
•
•
•
•
•
•
•
Precipitated by certain foods, alcohol, stress, sleep patterns
Peri-menstrual
60% of the time involves the neck region
Strong family history (“sick headaches”)
3:1 female
Worsened with bending over (it’s not your sinuses!)
Next day “hang-over headache”
Responds to caffeine
FAMOUS MIGRAINEURS
Botox Binds to the Nerve Terminal
Botox is Internalized into
the Nerve Ending
Botox Cleaves SNAP-25
Now the nerve can’t release acetylcholine and tell the muscle to
contract, so your wrinkles are gone!)
(
After 3 months, new nerve sprouts
develop
(and your wrinkles return)
Eventually the sprouts retract and the
original nerve ending regains its
normal function
(That’s why Botox is re-injected every 3 months)
Beverly Hills, CA October 15, 2010 William J. Binder M.D.,
F.A.C.S. Inc., Beverly Hills plastic surgeon and pioneer in the
cosmetic (anti-wrinkle) and therapeutic use of the BOTOX®
neurotoxin, made headlines in the early 1990’s by
discovering that BOTOX was effective in relieving the pain
and preventing the onset of migraine headaches. Friday the
U.S. Federal Drug Administration (FDA) approved BOTOX
injections as a preventative treatment for chronic migraine
sufferers.
Botox is only approved for
“Chronic Migraine”
•
•
So, what constitutes a
“Chronic Migraine”?
.
Diagnostic Criteria for Chronic
Migraine
• Chronic Migraine is a defined condition1-3
•
•
•
•
15 or more headache days per month
Headaches lasting 4 hours per day or more
At least 8 headache days classified as migraine days
With or without medication overuse
• What are migraine characteristics1?
Patients should experience at least 2 of these
pain characteristics:
And at least 1 of:
Unilateral
Nausea and/or vomiting
Migrainous, pulsating quality
Photophobia and
phonophobia
Moderate to severe intensity
Aggravated by routine
physical activity
1. Headache Classification Committee; Olesen J et al. Cephalalgia. 2004;24:9-160.
2. Headache Classification Committee; Olesen J et al. Cephalalgia. 2006;26:742-746.
3. Lipton RB. Headache. 2011;51(S2):77·83.
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PAR IV Movies Presents:
• Reality vs. Insurance Companies
So, how do we inject Botox for Chronic
Migraine?
Please see Important Safety Information, including Boxed Warning, throughout this deck.
BOTOX® for Chronic Migraine Patients: Recommended Order
of Injection* per Phase 3 Injection Paradigm1
Order*
Muscle
A
Corrugator†
B
Procerus
C
Frontalis†
20 Units divided in 4 sites
D
Temporalis†
40 Units divided in 8 sites
E
Occipitalis†
30 Units divided in 6 sites
F
Cervical paraspinals†
20 Units divided in 4 sites
G
Trapezius†
30 Units divided in 6 sites
Total number of Units
Total Dosage (Number of Sites**)
10 Units divided in 2 sites
5 Units in 1 site
155 Units divided in 31 sites
* Recommended order of injection based on phase 3 injection paradigm; table in prescribing information differs.
** Each IM injection site = 0.1 mL = 5 Units BOTOX®.
† Dose distributed bilaterally.
Dosing and results in these studies are specific to the formulation of BOTOX® manufactured by Allergan, Inc.
(Irvine, CA). The Allergan, Inc., formulation is not interchangeable with other botulinum toxin products and cannot
be converted using a dose ratio.
Patient is in supine position2
Patient is in sitting position2
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1. BOTOX® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., 2011.
2. Blumenfeld AM et al. Headache. 2010;50:1406-1418.
Facial Muscles
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