botox hh revised slides locked 10 30

BOTOX® (onabotulinumtoxinA)

Please refer to Important Safety Information including Boxed Warning on the following slides.

Indication

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

Please refer to Important Safety Information including Boxed Warning on the following slides.

Important Safety Information

DISTANT SPREAD OF TOXIN EFFECTPostmarketing reports indicate that the effects of BOTOX® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

Important Safety Information (con't)

. CONTRAINDICATIONSBOTOX® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGSThe recommended dosage and frequency of administration for BOTOX® should not be exceeded. Risks resulting from administration at higher dosages are not known.

Lack of Interchangeability Between Botulinum Toxin ProductsThe potency Units of BOTOX® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Important Safety Information (con't) Spread of Toxin EffectPostmarketing safety data from BOTOX® and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms.

Spread of Toxin Effect (con’t)In unapproved uses, including spasticity in children and adults, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

No definitive, serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® at the labeled dose of 100 Units (for severe primary axillary hyperhidrosis) have been reported.

Hypersensitivity reactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea.

.Pre-Existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases,amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX®.

ADVERSE REACTIONSGeneralThere have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin.There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.

Primary Axillary HyperhidrosisThe most frequently reported adverse events (3% to 10% of patients) following injection of BOTOX® for severe primary axillary hyperhidrosis include injection-site pain and hemorrhage, nonaxillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

For more information on BOTOX®, please see full prescribing information including medication guide provided.

OverdosageExcessive doses of BOTOX® may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.

In the event of suspected or actual overdosage, please contact your local or state health department to process a request for antitoxin through the Centers for Disease Control and Prevention (CDC). If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

Presentation Outline

1. Hyperhidrosis: The Condition

2. BOTOX® (onabotulinumtoxinA) Treatment Overview*

3. Clinical Trials

4. BOTOX® Preparation and Administration

5. Patient Frequently Asked Questions

6. Important Safety Information

Physiology of Sweating

Skin Surface

Preganglionic Sympathetic Neurons

Postganglionic Cholinergic Fibers

Sweat Gland

Spinal Cord and Sympathetic Nerves

What Is Hyperhidrosis?

• A condition of excessive sweating beyond what is needed to maintain normal body temperature 1

• According to one study, patients with axillary hyperhidrosis exhibit 4 to 5 times greater average sweat rate than healthy controls2

1. Hornberger et al. J Am Acad Dermatol. 2004.2. Hund et al. Arch Derm. 2002.

Please refer to Important Safety Information including Boxed Warning on slides 3 to 9.

Potential Causes of Primary Hyperhidrosis

Hyperhidrosis has no known etiology; these factors may play a role: Genetic (65% have family history)1

Sympathetic nervous system hyperactivity2

Sympathetic nervous system dysregulation2

Hypothalamic dysfunction3

1. Ro et al. J Vasc Surg. 2002; 2. Hornberger et al. J Am Acad Dermatol. 2004; 3. Smith. Neurology. 2001.

Prevalence of Severe Primary Axillary Hyperhidrosis (SPAHH)

An estimated 1.3 million Americans suffer from severe primary axillary hyperhidrosis

Approximately 66% of sufferers have never discussed it with a healthcare professional

Ages 18 to 54—the prime working years—are the period of highest incidence

1. Strutton et al. J Am Acad Dermatol. 2004.

Clinical Diagnosis and Treatment Algorithm

Clinical Diagnosis

Focal, visible, excessive sweating of at least 6 months’ duration without apparent cause with at least 2 of the following characteristics1*:

– Bilateral and relatively symmetric

– Impairment in daily activities

– Frequency of at least 1 episode per week

– Age of onset less than 25 years

– Positive family history

– Cessation of focal sweating during sleep*Diagnosis should be made only after excluding secondary causes of excessive sweating.

1. Hornberger et al. J Am Acad Dermatol. 2004.Please refer to Important Safety Information including Boxed Warning on slides 3 to 9.

Measuring Hyperhidrosis Severity

Hyperhidrosis Disease Severity Scale (HDSS)1

HDSS scores of 3 or 4 may be used as indicators of severe disease 1. Lowe et al. J Am Acad Dermatol. 2007

Treatment Algorithm

Surgery: local sweat gland resection orendoscopic thoracic sympathectomy (T7)

Intradermal injections of Botulinum Toxin Type A#3

Aluminum chloride 10%-35% topical antiperspirant#2

Evidence-Based Guidelines

Topical over-the-counter antiperspirants #1

1. Hornberger et al. J Am Acad Dermatol. 2004

BOTOX® (onabotulinumtoxinA) Background and Treatment Overview

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with

topical agents.

Please refer to Important Safety Information including Boxed Warning on slides 3 to 9.

History of BOTOX®

(onabotulinumtoxinA)

FDA approval of BOTOX® for cervical

dystonia

Dr. Scott initiates first therapeutic testing in

humansBotulinum Toxin

Type A first isolated

C botulinum identified

Dr. Schantz begins investigation

FDA approvalof BOTOX® for

strabismus andblepharospasm

FDA approval of BOTOX®

for the treatment of severe

primary axillary hyperhidrosisinadequately

managed with topical agents

FDA approval of BOTOX® Cosmetic for moderate to severe

glabellar lines

194419441920s1920s18951895 19781978 19891989 20022002 2004200420002000

1. Schantz et al. Perspect Biol Med. 1997;2. Schantz, Therapy with Botulinum Toxin 1994.

Please see full indications and Important Safety Information including Boxed Warning on the following slides.

Indications

BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.

Important Safety Information

Distant Spread of Toxin EffectPostmarketing reports indicate that the effects of BOTOX® or BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

Please refer to Important Safety Information on slides 65 to 72.

More About BOTOX® (onabotulinumtoxinA)

Approved in 83 countries Most-studied botulinum toxin and one of the most widely researched

medicines in the world

Please refer to Important Safety Information including Boxed Warning on slides 21 to 22 and slides 66 to 72.

BOTOX® (onabotulinumtoxinA) Mechanism of Action

Botulinum Toxin Type A (BoNT A) binds to sudomotor nerve terminals containing

acetylcholine

BOTOX®

sympathetic sudomotor neuron

sweat gland

BoNT A blocks release of acetylcholine; producing a temporary chemical

denervation of the sweat gland resulting in local reduction of sweating1,2

Acetylcholine Release is Blocked

(temporary neurolysis)1. Swartling et al. Am Acad Dermatol. 2004;2. BOTOX® Prescribing Information.

Clinical Studies

Clinical Study 1

Purpose: Examine efficacy and safety of BOTOX® for severe primary axillary hyperhidrosis inadequately managed by topical agents (SPAHH)

Design– 52-week, randomized, multicenter, double-blind, placebo-controlled study of 322 patients

diagnosed with SPAHH– Study responders:

Showed at least a 2-grade improvement from baseline on the HDSS 4 weeks after both of the first 2 treatment sessions

or Had a sustained response after their first treatment session and did not receive re-treatment

during the study– The percentage reduction in resting axillary sweat production from baseline by gravimetric analysis

and the duration of effect were also evaluated

1. Lowe et al. J Am Acad Dermatol. 2007;2. BOTOX® Prescribing Information.

Results: BOTOX® Reduced Scores

BOTOX® (onabotulinumtoxinA) vs placebo difference in response: 49.3% (95% CI: 38.8, 59.7) P < .001

HDSS ScoresStudy Responders

BOTOX® (50 units)(n = 104)

Placebo(n = 108)

• 55% of BOTOX® patients responded vs only 6% of placebo patients1,2

Please refer to Important Safety Information including Boxed Warning on slides 3 to 9, 21 to 22, and 66 to 72.

Results: BOTOX® Reduced Sweat

100BOTOX® (onabotulinumtoxinA) vs placebo difference in response:40% (95% CI: 28.1, 52.0) P < .001

Gravimetric MeasurementStudy Responders

BOTOX® (50 units)(n = 104)

Placebo(n = 108)

• 81% of BOTOX® patients achieved > 50% gravimetric sweat volume reduction vs only 41% of placebo patients1,2

Results: BOTOX® Response for up to 6.7 Months1,2

201-day median duration of response*

*1 to 2 BOTOX® injections were sufficient for most patients who responded to BOTOX® treatment in the 52-week pivotal clinical study

1 2 3 4 5 6 7 8 9 10 11 12Months

6.7-month duration6.7-month duration

Clinical Study 2

Purpose: Examine the efficacy and safety of BOTOX® treatment for SPAHH inadequately managed by topical agents1, 2

Design: 16-week, double-blind, parallel-group, multicenter, placebo-controlled study of 320 patients

– Response was defined as > 50% reduction in axillary sweating at 4 weeks

1. Naumann and Lowe. Br Med J. 2001; 2. BOTOX® Prescribing Information.

Results: BOTOX® Reduced Sweat1,2

100 BOTOX® (onabotulinumtoxinA) vs placebo difference in response: 55% (95% CI: 43.3, 65.9) P < .001

BOTOX® (50 units) (n = 242)

Placebo(n = 78)

• 91% of BOTOX® patients achieved a > 50% gravimetric sweat volume reduction (P < .001) vs only 36% of placebo patients1,2

1. Naumann and Lowe. Br Med J. 2001; 2. BOTOX® Prescribing Information.

Summary

SPAHH inadequately managed by topical agents is usually idiopathic– Must identify and treat any underlying cause before treating

symptoms

SPAHH can be barely tolerable or intolerable and frequently or always interferes with daily activities

BOTOX® patients in clinical trials achieved:– Significant improvement on the Hyperhidrosis Disease Severity

Scale (HDSS)– Significant reductions of sweat volume for a duration of up to 201 days

BOTOX® (onabotulinumtoxinA) Preparation and Administration

Preparations for the BOTOX® (onabotulinumtoxinA) Procedure

Schedule patient treatment visit Order proper number of BOTOX® vials

(not BOTOX® Cosmetic)

Patient Preparation

1. Shave underarms2. Abstain from use of over-the-counter deodorants or

antiperspirants for 24 hours prior to treatment3. Rest comfortably without exercise, hot beverages, etc, for

approximately 30 minutes prior to treatment

Two Options for Identifying Hyperhidrotic Area

Iodine Starch Test Follicular outline

BOTOX® for SPAHH: Preparation and Administration

Another method to identify hyperhidrotic area is the follicular outlinePlease refer to Important Safety Information including Boxed Warning on slides 3 to 9, 21 to 22, and 66 to 72.

Reconstitution

Allergan logo should appear in holographic lettering on vial

Each vial contains 100 U of vacuum-dried Clostridium botulinum type A neurotoxin complex (BOTOX® [onabotulinumtoxinA])

As stated in the package insert, BOTOX® is only reconstituted with 0.9% nonpreserved sterile saline at a ratio of 100 U/4.0 mL

Reconstitution—5 Easy Steps

Using a 20-gauge, 1½-inch needle, draw 4 mL of 0.9% nonpreserved sterile saline.

Insert needle at a 45º angle and slowly inject saline into BOTOX® (onabotulinumtoxinA) vial. Ensure vacuum is present, which means sterility of vial is intact. Do not use vialif there is no vacuum present.

Reconstitution—5 Easy Steps (continued)

Release vacuum by disconnecting syringe from needle and allowing air to flow into vial and neutralize pressure. Gently mix BOTOX

® (onabotulinumtoxintypeA) with

saline by rotating vial; do not invert.

Attach a new sterile syringe to remaining needle and draw fluid from bottom corner of vial for full extraction; do not invert.

Reconstitution—5 Easy Steps (continued)

Remove reconstitution needle from syringe and attach a 30-gauge injection needle, which is recommended for axillary injections.

Iodine Starch Test

First dry affected axilla. Then paint axilla with iodine solution, making sure to cover excess area around axilla. Allow iodine to dry.

Brush area with starch powder and wait10 minutes. (A blue-black mark identifies affected area.)

Iodine Starch Test

Circle affected area with a surgical marker, then clean area inside circle with alcohol.

Use a surgical pen and standard ruler to mark injection points 1.5 to 2 cm apart and staggered.

Count injection points and allocate recommended dosage of BOTOX® (onabotulinumtoxintypeA) solution per injection, based on 50 Units per axilla.

Iodine Starch Test

BOTOX® (onabotulinumtoxinA) Injection

Injection: Inject to a depth of approximately 2 mm and at a 45º angle to skin surface with bevel side up. Be sure not to inject directly on ink mark to avoid a permanent tattoo effect. After injection, clean treated area with alcohol.

Follicular Outline Can Be Used to Identify Hyperhidrotic Area

Circle hair-bearing area with a surgical marker, then clean area inside circle with alcohol.

Follow the same injection protocol

1. Kaufman et al. Therapeutic Uses of Botulinim Toxin. 2007.

Frequently Asked Patient Questions With Answers

What is BOTOX®?

BOTOX® is a prescription medicine that is injected into muscles and used to treat the symptoms of severe underarm sweating when medicines used on the skin do not work well enough

– Temporarily blocks chemical signals from the nerves that stimulate the sweat glands. When the sweat glands don't receive chemical signals, the excessive sweating stops.

What Is the History of BOTOX®?

For the most up-to-date safety information speak to your healthcare professionals

BOTOX® neurotoxin– Approved in 2004 for excessive underarm sweating when

antiperspirants fail– Used therapeutically for approximately 20 years to treat a variety

of medical conditions– Approved in 83 countries– One of the most widely researched medicines in the world

What Are the Possible Side Effects of BOTOX®?

BOTOX ® can cause serious side effects– See “What is the most important information I should know about BOTOX®?”

in Medication Guide Other side effects include:

– Dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of the eyelids, and dry eyes may occur

– Symptoms of an allergic reaction to BOTOX® may include: itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Will I Get the “Real” BOTOX®?

Only licensed and trained healthcare professionals have the experience necessary to administer BOTOX®. Allergan, Inc., the manufacturer of BOTOX® neurotoxin, is the only source for healthcare professionals to purchase the product, and each vial’s label has the “Allergan” hologram

Who Should Not Receive BOTOX®?

Patients should not be treated with BOTOX® neurotoxin if – They are allergic to any ingredients in BOTOX®

– They have had an allergic reaction to any other botulinum toxin product such as Myobloc® and Dysport™

– They have had a skin infection at the planned injection site– They have certain neurological disorders such as

ALS, myasthenia gravis, or Lambert-Eaton syndrome These may increase the risk of serious side effects

What Is the Procedure Like?

The actual procedure – Takes about 10 to 15

minutes– Involves multiple

injections in the area that needs to be treated

Is the Procedure Painful? Will I Need Anesthesia?

It causes little discomfort; most patients compare the sensation to a bug bite. Overall, the discomfort is minimal and temporary

You will not need anesthesia but your healthcare professional may choose to numb the injected area with a cold pack or anesthetic cream before the actual treatment

Does the Treatment Work? How Long Will it Last? How Soon Will I See Results?

You should notice a significant reduction in underarm sweating within 4 weeks of your first treatment

A BOTOX® treatment lasts about 201 days or up to 6.7 months BOTOX® injections are not a permanent cure for severe

underarm sweating and your symptoms will gradually return– When symptoms return, the time is right for another treatment

Isn’t It Unhealthy to Stop Sweating? Where Does the Sweat Go?

People who need BOTOX® for SPAHH that is inadequately managed by topical agents have overactive sweat glands in their underarms. BOTOX® neurotoxin injections temporarily stop production of sweat in the treated areas only. Sweat continues to be produced elsewhere

Your sweat doesn’t go anywhere else or get backed up because the sweat simply isn’t produced in the areas treated with BOTOX®

– The rest of your body is free to release moisture normally– If you were to stop BOTOX® treatment, or when it wears off months

later, the sweating function returns to the same level you experienced before starting treatment

How Much Does BOTOX® Cost? Will My Insurance Cover It? What if It Doesn’t?

When prescription antiperspirants have failed– The majority of insurance authorization requests submitted through BOTOX®

Reimbursement Solutions are approved1

– Approval is not necessarily automatic and some paperwork is required from your doctor’s office

– Many sufferers are pleasantly surprised to find out their healthcare plans cover most or all the cost of BOTOX® treatment for excessive underarm sweating1

If your insurance company does not cover BOTOX® treatment, ask your doctor’s office to see if they offer an interest-free extended-payment program

1Data on file, Allergan, Inc. 2007.

If Patients Ask, “Where Can I Find Out About Patient Experiences With BOTOX®?”

Talk to your healthcare professional or visit the website www.DontSweat-it.com

Reimbursement

Why be concerned with reimbursement?

Cost may be a reason patients have not asked their physicians about BOTOX® for SPAHH inadequately managed by topical agents

The majority of insurance authorization requests for coverage via BRS are approved for BOTOX® treatment for SPAHH when inadequately managed with topical agents1

1Data on file, Allergan, Inc..

BOTOX® Reimbursement Solutions (BRS) Hotline Offerings

Immediate access to all your active BOTOX® patients– Patient list provides the current reimbursement status of all your patients

Insurance verifications Prior authorizations (PA) – links to payer PA forms Claims appeals Ability to look up payer policies View online benefit-investigation summaries

– Secure messaging directly with staff– Once daily e-mail summarizes all benefit investigations completed each day

Access the BOTOX PATIENT ASSISTANCE® Program

Steps to Process Reimbursement Through the BRS Hotline and Website

PRETREATMENT1 TO 2 MONTHS BEFORE TREATMENT

DAY OF TREATMENT POSTTREATMENT

Insurance Verification (IV) Prior Authorization (PA)

Four weeks before injection day:Send IV request (via phone, fax, or Web)Include LOMN, clinical notes, patient’s ICD-9 and CPT® codesAdd patient’s insurance ID numbers and phone number(s). Within 1 business day of IV request:

–Reimbursement Counselor will

call you for any missing

information

Within 2 business days of IV request:Reimbursement Counselor will call you with results of your IV request and let you know if a PA is neededYou will also receive a confirmation e-mailView current patient IV and PA status on BRS WebsiteInput up to 16 future dates of service to automatically initiate the PA process for patientsBRS can evaluate potential coverage under the BOTOX PATIENT ASSISTANCE® Program

Collect all applicable co-paymentsSchedule patient for next injectionSubmit claimComplete chart documentation

- Please go to the BRS Website for chart documentation example

Four weeks before patient’s next injection: Start the automatic PA process by entering up to 16 future dates of service

Six to 12 weeks after submission of claim:–Payment should be received

–Initiate appeal if claim is underpaid

or denied

–If appeal is denied, evaluate patient

for the BOTOX PATIENT

ASSISTANCE® Program

–BRS can help facilitate appeals and

assess grounds for denial and

underpayment

What Are the Users Saying?

Timely response– 86% of insurance verifications (n = 4864) are completed within 1

business day– 99% of calls are answered within 5 seconds– 77% of prior authorizations (n = 915) are completed within 20

business days– 100% of the time (n = 16), payer research results are obtained

the same day

1. Lash Group. BOTOX® Reimbursement Solutions Program Activity Summary. Charlotte, NC: Lash Group; July 1, 2008.

Three Points of Contact to Get Started

CALL the BOTOX® Reimbursement Hotline: To reach regionally focused Reimbursement Counselors directly, call the BRS Hotline at 1-800-44-BOTOX, Option 4

CLICK on the BOTOX® Reimbursement Web site: Complete online access for your reimbursement practice needs. Please visit www.BOTOXReimbursementSolutions.com

CONTACT the Reimbursement Business Managers (RBMs): Your partner for the education, support, and services your practice needs to help overcome reimbursement issues

. CONTRAINDICATIONSBOTOX® and BOTOX® Cosmetic are contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. WARNINGSThe recommended dosage and frequency of administration for BOTOX® or BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are not known. Lack of Interchangeability Between Botulinum Toxin ProductsThe potency Units of BOTOX® and BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® and BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.

WARNINGS (con’t)

Spread of Toxin EffectPostmarketing safety data from BOTOX® and BOTOX® Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms.

WARNINGS (con’t)Spread of Toxin Effect In unapproved uses, including spasticity in children and adults, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia. No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX®/BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported. No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm at the recommended dose (30 Units and below) or for strabismus at the labeled doses have been reported..

WARNINGS (con’t)Hypersensitivity ReactionsSerious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. Pre-Existing Neuromuscular DisordersIndividuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® or BOTOX® Cosmetic.

ADVERSE REACTIONSGeneralThe most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility.There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease.

ADVERSE REACTIONS (con’t)Cervical DystoniaThe most frequently reported adverse reactions following injection of BOTOX® for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). BlepharospasmThe most frequently reported treatment-related adverse reactions following injection of BOTOX® for blepharospasm include ptosis (20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).StrabismusThe most frequently reported adverse events following injection of BOTOX® for strabismus include ptosis (15.7%) and vertical deviation (16.9%).

ADVERSE REACTIONS (con’t)

Primary Axillary HyperhidrosisThe most frequently reported adverse events (3% to 10% of patients) following injection of BOTOX® for severe primary axillary hyperhidrosis include injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety. Glabellar LinesThe most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.

ADVERSE REACTIONS (con’t)

OverdosageExcessive doses of BOTOX® or BOTOX® Cosmetic may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.In the event of suspected or actual overdosage, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

For more information on BOTOX® and BOTOX® Cosmetic, please refer to full prescribing information including medication guide provided.

References

BOTOX® Policy Database, January 2006. BOTOX® Prescribing Information, 2009. Data on file, Allergan, Inc. Hornberger J, Grimes K, Naumann M, et al; Multi-Specialty Working Group on The Recognition, Diagnosis, and

Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004;51(2):274-286.

Hund M, Kinkelin I, Naumann M, Hamm H. Definition of axillary hyperhidrosis by gravimetric assessment. Arch Dermatol. 2002;138(4):539-541.

Kaufman J, Baumann L. Hyperhidrosis. In: Cooper G, ed. Therapeutic Uses of Botulinum Toxin. Totowa, NJ: Humana Press; 2007:153-166.

Lash Group. BOTOX® Reimbursement Solutions Program Activity Summary. Charlotte, NC: Lash Group; July 1, 2008. Lowe NJ, Glaser DA, Eadie N, Daggett S, Kowalski JW, Lai PY, North American BOTOX® in Primary Axillary

Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol. 2007;56(4):604-611.

Naumann MK, Hamm H, Lowe NJ; for BOTOX® Hyperhidrosis Clinical Study Group. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. Br J Dermatol. 2002;147(6):1218-1226.

References (continued)

Naumann M, Lowe NJ, for Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind placebo controlled trial. Br Med J. 2001;323(73):596-599.

Ro KM, Cantor RM, Lange KL, Ahn SS. Palmar hyperhidrosis: evidence of genetic transmission. J Vasc Surg. 2002;35(2):382-386.

Schantz EJ, Johnson EA. Botulinum toxin: the story of its development for the treatment of human disease. Perspect

Biol Med. 1997;40(3):317-327. Schantz EJ. Historical perspective. In: Jankovic J, Hallet M, eds. Therapy with Botulinum Toxin. New York, NY: Marcel

Dekker Inc; 1994:xxiii-xxvi. Smith CD. A hypothalamic stroke producing recurrent hemihyperhidrosis. Neurology. 2001;56(10):1394-1396. Strutton DR, Kowalski JW, Glaser DA, Stang PE. US prevalence of hyperhidrosis and impact on individuals with axillary

hyperhidrosis: results from a national survey. J Am Acad Dermatol. 2004;51(2):241-248. Swartling C, Naver H, Pihl-Lundin I, Hagforsen E, Vahlquist A. Sweat gland morphology and periglandular innervation in

essential palmer hyperhidrosis before and after intradermal botulinum toxin. Am Acad Dermatol. 2004;51(4):739-745.

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