Injection Workbook for Chronic Migraine Chronic for Workbook Injection

Bleed: Live: Doc. Size: Doc. ieLcto:Studio Aesthetics File Location: AD/Designer: Client: Introduction

This workbook is designed to help you learn and apply the proven BOTOX® Injection Paradigm. It also contains information to help injectors identify appropriate BOTOX® candidates, understand + 0.125” + w 8.75" xh11.25" Bret P CM Botox procedure-related anatomy, manage patient expectations, and integrate the procedure into the practice.

Reference material accompanying this workbook:

Reconstitution pocket guide NOTES: Studio Artist: Kristina K Kristina Studio Artist: Output Scale: Mgr: r g M c ﬁ f a r T Number: Job

The following supplies will be needed prior to beginning IMPORTANT SAFETY INFORMATION (continued) IMPORTANT SAFETY INFORMATION (continued) the reconstitution procedure: WARNINGS AND PRECAUTIONS (continued) ADVERSE REACTIONS Serious Adverse Reactions With Unapproved Use The following adverse reactions to BOTOX® for injection are discussed Reconstitution/ Serious adverse reactions, including excessive weakness, dysphagia, in greater detail in the following sections: Spread of Toxin Effect and aspiration pneumonia, with some adverse reactions associated (see Boxed Warning); Serious Adverse Reactions With Unapproved Injection l One 200-Unit vial of BOTOX® with fatal outcomes, have been reported in patients who received Use (see Warnings and Precautions); Hypersensitivity Reactions (see BOTOX® injections for unapproved uses. In these cases, the adverse Contraindications and Warnings and Precautions); Increased Risk know if we need to “reset” content margins and let vendor re-do any adjustments. See Omar for any questions. any for Omar See adjustments. any re-do vendor let and margins content “reset” to weneed if know ( 100% (onabotulinumtoxinA) S Steve 153331 reactions were not necessarily related to distant spread of toxin, of Clinically Significant Effects With Pre-Existing Neuromuscular — but may have resulted from the administration of BOTOX® to the Disorders (see Warnings and Precautions); and Dysphagia and Pocket Card l One 21-gauge, 2-inch needle site of injection and/or adjacent structures. In several of the cases, Breathing Difficulties (see Warnings and Precautions). Studio let and ﬁ in review Mto still are Michelle on vendor by done waiting le; adjustments Creep print. not do lines ) Die (for reconstitution) patients had pre-existing dysphagia or other significant disabilities. Chronic Migraine ® There is insufficient information to identify factors associated with an This pocket card is a reference guide for BOTOX (onabotulinumtoxinA) The most frequently reported adverse reactions following injection injection sites for Chronic Migraine patients. The reconstitution l One 5-mL syringe increased risk for adverse reactions associated with the unapproved of BOTOX® for chronic migraine include neck pain (9%), headache ® ® materials, dilution table, and Injection Paradigm are highlighted for uses of BOTOX. The safety and effectiveness of BOTOX for (5%), eyelid ptosis (4%), migraine (4%), muscular weakness (4%), unapproved uses have not been established. quick reference. l Four 1-mL tuberculin syringes musculoskeletal stiffness (4%), bronchitis (3%), injection-site pain (for injection) Hypersensitivity Reactions (3%), musculoskeletal pain (3%), myalgia (3%), facial paresis (2%), Serious and/or immediate hypersensitivity reactions have been hypertension (2%), and muscle spasms (2%). Indication reported. These reactions include anaphylaxis, serum sickness, Chronic Migraine l At least four 30-gauge, 0.5-inch Post Marketing Experience BOTOX® for injection is indicated for the prophylaxis of headaches urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, There have been spontaneous reports of death, sometimes needles (for injection) further injection of BOTOX® should be discontinued and appropriate in adult patients with chronic migraine (≥ 15 days per month with associated with dysphagia, pneumonia, and/or other significant headache lasting 4 hours a day or longer). medical therapy immediately instituted. One fatal case of anaphylaxis debility or anaphylaxis, after treatment with botulinum toxin. There l One 10-mL single-use vial of has been reported in which lidocaine was used as the diluent, and have also been reports of adverse events involving the cardiovascular Important Limitations preservative-free, 0.9% consequently the causal agent cannot be reliably determined. system, including arrhythmia and myocardial infarction, some with Safety and effectiveness have not been established for the prophylaxis Q/C Check: Q/C Size: Print Page sodium chloride (saline) Increased Risk of Clinically Significant Effects With Pre-Existing fatal outcomes. Some of these patients had risk factors including of episodic migraine (14 headache days or fewer per month) in 7 Mgr: Prod Description: Neuromuscular Disorders cardiovascular disease. The exact relationship of these events to the placebo-controlled studies. l Alcohol swabs for cleaning the Individuals with peripheral motor neuropathic diseases, amyotrophic botulinum toxin injection has not been established. IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING rubber stoppers on the saline and lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia DRUG INTERACTIONS gravis or Lambert-Eaton syndrome) should be monitored when given ® BOTOX® vials Co-administration of BOTOX and aminoglycosides or other agents WARNING: DISTANT SPREAD OF TOXIN EFFECT botulinum toxin. Patients with neuromuscular disorders may be at interfering with neuromuscular transmission (eg, curare-like Postmarketing reports indicate that the effects of BOTOX® and all increased risk of clinically significant effects including generalized compounds) should only be performed with caution as the effect l Gauze pads botulinum toxin products may spread from the area of injection to muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe of the toxin may be potentiated. Use of anticholinergic drugs after produce symptoms consistent with botulinum toxin effects. These dysphagia, and respiratory compromise from therapeutic doses of administration of BOTOX® may potentiate systemic anticholinergic ® may include asthenia, generalized muscle weakness, diplopia, ptosis, l 1 pair of gloves BOTOX (see Warnings and Precautions). effects. The effect of administering different botulinum neurotoxin dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing Dysphagia and Breathing Difficulties products at the same time or within several months of each other is TbldO difficulties. These symptoms have been reported hours to weeks after Michelle M Update Cover Injection Workbook Treatment with BOTOX® and other botulinum toxin products can result unknown. Excessive neuromuscular weakness may be exacerbated l Hazardous medical waste container injection. Swallowing and breathing difficulties can be life threatening, in swallowing or breathing difficulties. Patients with pre-existing by administration of another botulinum toxin prior to the resolution and there have been reports of death. The risk of symptoms is probably swallowing or breathing difficulties may be more susceptible to these of the effects of a previously administered botulinum toxin. Excessive greatest in children treated for spasticity, but symptoms can also occur complications. In most cases, this is a consequence of weakening weakness may also be exaggerated by administration of a muscle in adults treated for spasticity and other conditions, particularly in of muscles in the area of injection that are involved in breathing or relaxant before or after administration of BOTOX®. those patients who have an underlying condition that would predispose oropharyngeal muscles that control swallowing or breathing (see Please see accompanying full Prescribing Information including them to these symptoms. In unapproved uses, including spasticity in Boxed Warning). Ensure you have received authentic Boxed Warning and Medication Guide. children, and in approved indications, cases of spread of effect have BOTOX® from Allergan. Look for the Human Albumin and Transmission of Viral Diseases References: been reported at doses comparable to those used to treat cervical holographic film on the vial; “Allergan” This product contains albumin, a derivative of human blood. Based 1. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method dystonia and spasticity and at lower doses. should appear within the rainbow lines. on effective donor screening and product manufacturing processes, it of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and carries an extremely remote risk for transmission of viral diseases. A effective treatment paradigm based on the PREEMPT clinical program. Headache. theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is 2010;50(9):1406-1418. 2. BOTOX® Prescribing Information, January 2016. also considered extremely remote. No cases of transmission of viral Please see additional Important diseases or CJD have ever been reported for albumin. © 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners. BOTOXMedical.com/ChronicMigraine Safety Information about 1-800-44-BOTOX APC54GS16 160853 BOTOX® inside. Date: Revision #: Brand Lead:Brand Final Output:

IMPORTANT SAFETY INFORMATION (continued) CONTRAINDICATIONS 02/25/2016 collect Omar H Omar 144 +PMS CMYK BOTOX® 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. WARNINGS AND PRECAUTIONS Lack of Interchangeability Between Botulinum Toxin Products The potency Units of BOTOX® are specifi c to the preparation and assay method utilized. They X are not interchangeable with other preparations of botulinum toxin products and, therefore, Comp Lite Mech Mechanical Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specifi c assay method. Spread of Toxin Effect See Boxed Warning. No defi nitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for

2 chronic migraine at the labeled dose have been reported.

Please see additional Important Safety Information about BOTOX about Information Safety Important additional see Please on following pages. following on

APC55BL15 153331 APC55BL15 1-800-44-BOTOX BOTOXReimbursementSolutions.com AccessBSC.com BOTOXMedical.com/ChronicMigraine

those used to treat cervical dystonia and spasticity and at lower doses. lower at and spasticity and dystonia cervical treat to used those

in approved indications, cases of spread of effect have been reported at doses comparable to to comparable doses at reported been have effect of spread of cases indications, approved in

predispose them to these symptoms. In unapproved uses, including spasticity in children, and and children, in spasticity including uses, unapproved In symptoms. these to them predispose

26. . Analysis Program Savings 2014; December to January Inc., Allergan, le, ﬁ on Data Analysis. Policy Preventives Inc.; Allergan,

and other conditions, particularly in those patients who have an underlying condition that would would that condition underlying an have who patients those in particularly conditions, other and 25. 24. Data on ﬁ le, le, ﬁ on Data 2010;50(8):1273-1277. . Headache migraine. in pain neck of prevalence The Y. Nie Y, Truong AG, Finkel C, Millen S, Ford AH, Calhoun

23. 22. Data on fi le, Allergan, Inc.; Summary of Clinical Safety. Safety. Clinical of Summary Inc.; Allergan, le, fi on Data Report. Final 2 PREEMPT Inc.; Allergan, le, fi on Data Report. Final 1 PREEMPT Inc.; Allergan,

in children treated for spasticity, but symptoms can also occur in adults treated for spasticity spasticity for treated adults in occur also can symptoms but spasticity, for treated children in

21. 20. Data on ﬁ le, le, ﬁ on Data 2006. Wilkins; & Williams Lippincott MD: Baltimore, ed. 28th . Dictionary Medical Stedman’s 2011. Publishing-USA; Medical People’s CT:

19. 3rd ed. Shelton, Shelton, ed. 3rd Surgery. Maxillofacial and Oral of Principles Peterson’s P. Waite P, Larsen GE, Ghali M, Miloro 2008. Livingstone; Churchill England: London,

threatening, and there have been reports of death. The risk of symptoms is probably greatest greatest probably is symptoms of risk The death. of reports been have there and threatening,

18. . 40th ed. ed. 40th . Practice Clinical of Basis Anatomical The Anatomy: Gray’s ed. S, Standring 2005;45(4):293-307. . Headache trial. placebo-controlled double-blind,

been reported hours to weeks after injection. Swallowing and breathing difﬁ culties can be life life be can culties difﬁ breathing and Swallowing injection. after weeks to hours reported been

) for the prophylactic treatment of chronic daily headache: a randomized, randomized, a headache: daily chronic of treatment prophylactic the for ) (BOTOX A type toxin Botulinum Group. Study CDH R, Gibson J, Turkel C; BOTOX C; Turkel J, Gibson R,

® ®

17. Mathew NT, Frishberg BM, Gawel M, Dimitrova Dimitrova M, Gawel BM, Frishberg NT, Mathew 2005;80(9):1126-1137. . Proc Clin Mayo trial. placebo-controlled double-blind, randomized, a headache:

dysphonia, dysarthria, urinary incontinence, and breathing difﬁ culties. These symptoms have have symptoms These culties. difﬁ breathing and incontinence, urinary dysarthria, dysphonia,

SD, Stark SR, Lucas SM, Christie SN, DeGryse RE, Turkel CC; BoNTA-039 Study Group. Botulinum toxin type A for the prophylactic treatment of chronic daily daily chronic of treatment prophylactic the for A type toxin Botulinum Group. Study BoNTA-039 CC; Turkel RE, DeGryse SN, Christie SM, Lucas SR, Stark SD,

effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphagia, ptosis, diplopia, weakness, muscle generalized asthenia, include may These effects. 16. Silberstein Silberstein 2007;47(4):486-499. . Headache study. exploratory placebo-controlled double-blind, randomized, a migraine: episodic of treatment prophylactic

15. North American Episodic Migraine Study Group. Botulinum toxin type A A type toxin Botulinum Group. Study Migraine Episodic American North Aurora SK, Gawel M, Brandes JL, Pokta S, VanDenburgh AM; BOTOX AM; VanDenburgh S, Pokta JL, Brandes M, Gawel SK, Aurora 492-503.

® may spread from the area of injection to produce symptoms consistent with botulinum toxin toxin botulinum with consistent symptoms produce to injection of area the from spread may

. 2007;27(6): . Cephalalgia headaches. migraine episodic of prophylaxis the for (BoNTA) A type toxin botulinum of treatments multiple of study group parallel

Schoenen J, Pascual J, Lei X, Thompson C; for the European BoNTA Headache Study Group. A multicentre, double-blind, randomized, placebo-controlled, placebo-controlled, randomized, double-blind, multicentre, A Group. Study Headache BoNTA European the for C; Thompson X, Lei J, Pascual J, Schoenen and all botulinum toxin products products toxin botulinum all and Postmarketing reports indicate that the effects of BOTOX of effects the that indicate reports Postmarketing

® 14. Relja M, Poole AC, AC, Poole M, Relja 2007;8(6):478-485. . Med Pain migraine. episodic of prevention the in doses and sites injection A type toxin botulinum of comparison

13. Saper JR, Mathew NT, Loder EW, DeGryse R, VanDenburgh AM; for the BoNTA-009 Study Group. A double-blind, randomized, placebo-controlled placebo-controlled randomized, double-blind, A Group. Study BoNTA-009 the for AM; VanDenburgh R, DeGryse EW, Loder NT, Mathew JR, Saper WARNING: DISTANT SPREAD OF TOXIN EFFECT TOXIN OF SPREAD DISTANT WARNING:

. 2006;7(10):688-696. 2006;7(10):688-696. . Pain J prophylaxis. migraine for A type toxin botulinum with treatments repeated of studies controlled randomized, sequential, three

12. Elkind AH, O’Carroll P, Blumenfeld A, DeGryse R, Dimitrova R; for the BoNTA-024-026-036 Study Group. A series of of series A Group. Study BoNTA-024-026-036 the for R; Dimitrova R, DeGryse A, Blumenfeld P, O’Carroll AH, Elkind 2000;123(6):669-676. . Surg Neck

Otolaryngol Head Head Otolaryngol study. open-label an headaches: migraine of treatment for ) Brin MF, Blitzer A, Schoenrock LD, Pogoda JM. Botulinum toxin type A (BOTOX A type toxin Botulinum JM. Pogoda LD, Schoenrock A, Blitzer MF, Brin

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING BOXED INCLUDING INFORMATION, SAFETY IMPORTANT 11. Binder WJ, WJ, Binder 2010;50(9):1406-1418. . Headache program. clinical PREEMPT the on based paradigm treatment effective and well-tolerated, safe, a migraine:

10. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic chronic for onabotulinumtoxinA of injection of Method WJ. Binder CC, Turkel SK, Aurora DW, Dodick SD, Silberstein A, Blumenfeld 2010;50(6):921-936.

. . Headache program. clinical PREEMPT the of phases placebo-controlled randomized, double-blind, the from results pooled migraine: chronic of treatment

(14 headache days or fewer per month) in 7 placebo-controlled studies. placebo-controlled 7 in month) per fewer or days headache (14

9. Dodick DW, Turkel CC, DeGryse RE, et al; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for for OnabotulinumtoxinA Group. Study Migraine Chronic PREEMPT al; et RE, DeGryse CC, Turkel DW, Dodick 2003;43(4):336-342. . Headache migraine.

Safety and effectiveness have not been established for the prophylaxis of episodic migraine migraine episodic of prophylaxis the for established been not have effectiveness and Safety Sheftell FD. Assessment of migraine disability using the migraine disability assessment (MIDAS) questionnaire: a comparison of chronic migraine with episodic episodic with migraine chronic of comparison a questionnaire: (MIDAS) assessment disability migraine the using disability migraine of Assessment FD. Sheftell

8. 8. Bigal ME, Rapoport AM, Lipton RB, Tepper SJ, SJ, Tepper RB, Lipton AM, Rapoport ME, Bigal 2013;33(9):629-808. . Cephalalgia version). (beta edition 3rd Disorders, Headache of cation Classiﬁ International Important Limitations Important

7. 7. Headache Classiﬁ cation Committee of the International Headache Society (IHS). The The (IHS). Society Headache International the of Committee cation Classiﬁ Headache 2001;41(4):343-350. . Headache needs. treatment and severity illness

6. Holmes WF, MacGregor EA, Sawyer JPC, Lipton RB. Information about migraine disability inﬂ uences physicians’ perceptions of of perceptions physicians’ uences inﬂ disability migraine about Information RB. Lipton JPC, Sawyer EA, MacGregor WF, Holmes 2013;53(4):644-655.

migraine (≥ 15 days per month with headache lasting 4 hours a day or longer). or day a hours 4 lasting headache with month per days 15 (≥ migraine

. . Headache (IBMS-II). Study Migraine of Burden International Second the from results migraine: chronic and migraine episodic for medications prophylactic of

5. Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation discontinuation for reasons and use of Patterns al. et WJ, Becker LM, Bloudek AM, Blumenfeld 2000;55(6):754-762. . Neurology Neurology. of Academy

BOTOX for injection is indicated for the prophylaxis of headaches in adult patients with chronic chronic with patients adult in headaches of prophylaxis the for indicated is injection for

® parameter: evidence-based guidelines for migraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American American the of Subcommittee Standards Quality the of Report review). evidence-based (an headache migraine for guidelines evidence-based parameter:

Chronic Migraine Chronic

4. 3. Silberstein SD; US Headache Consortium. Practice Practice Consortium. Headache US SD; Silberstein 2006;354(2):158-165. . Med J Engl N headache. daily Chronic DW. Dodick 2):77S-83S. (suppl

2. 1. . 2011;51 . Headache epidemiology. and diagnosis, differential cation, classiﬁ migraine, Chronic RB. Lipton 2016. January Information, Prescribing BOTOX

Indication ®

References:

Please see Important Safety Information including Boxed Warning inside. Warning Boxed including Information Safety Important see Please

BOTOXAcademy.com

patient education and more: and education patient

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Contact your Allergan representative Allergan your Contact

For Neuroscience Business Practice Specialists: Practice Business Neuroscience For

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PROFESSIONAL EDUCATION & RESOURCES & EDUCATION PROFESSIONAL

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procedure, and discussing treatment with patients with treatment discussing and procedure, For uninsured or underinsured patients: underinsured or uninsured For

candidates, the injection injection the candidates, BOTOX identifying for Guidance

AccessBSC.com AccessBSC.com

For commercially insured patients: patients: insured commercially For

Injection Workbook for Chronic Migraine Chronic for Workbook Injection

PATIENT FINANCIAL ASSISTANCE FINANCIAL PATIENT

1-800-433-8871

ALLERGAN MEDICAL INFORMATION LINE INFORMATION MEDICAL ALLERGAN

1-800-44-BOTOX (1-800-442-6869), Option 4 Option (1-800-442-6869), 1-800-44-BOTOX

CUSTOMER SERVICE CUSTOMER

1-800-44-BOTOX (1-800-442-6869), Option 1 Option (1-800-442-6869), 1-800-44-BOTOX

AllerganDirect.com or call call or AllerganDirect.com

ORDERING Helpful phone numbers and websites for you for websites and numbers phone Helpful Live: Bleed: Doc. Size: Doc. ieLcto:Studio Aesthetics File Location: AD/Designer: Client: Introduction Notes page to come This workbook is designed to help you learn and apply the proven BOTOX® Injection Paradigm. It also contains information to help injectors identify appropriate BOTOX® candidates, understand + 0.125” + w 8.75" x h 11.25" Bret P CM Botox procedure-related anatomy, manage patient expectations, and integrate the procedure into the practice.

Reference material accompanying this workbook:

Reconstitution pocket guide NOTES: Studio Artist: Kristina K Kristina Studio Artist: Output Scale: Mgr: r g M c ﬁ f a r T Number: Job

The following supplies will be needed prior to beginning IMPORTANT SAFETY INFORMATION (continued) IMPORTANT SAFETY INFORMATION (continued) the reconstitution procedure: WARNINGS AND PRECAUTIONS (continued) ADVERSE REACTIONS Serious Adverse Reactions With Unapproved Use The following adverse reactions to BOTOX® for injection are discussed Reconstitution/ Serious adverse reactions, including excessive weakness, dysphagia, in greater detail in the following sections: Spread of Toxin Effect and aspiration pneumonia, with some adverse reactions associated (see Boxed Warning); Serious Adverse Reactions With Unapproved Injection l One 200-Unit vial of BOTOX® with fatal outcomes, have been reported in patients who received Use (see Warnings and Precautions); Hypersensitivity Reactions (see BOTOX® injections for unapproved uses. In these cases, the adverse Contraindications and Warnings and Precautions); Increased Risk ( know if we need to “reset” content margins and let vendor re-do any adjustments. See Omar for any questions. any for Omar See adjustments. any re-do vendor let and margins content “reset” to we need if know 100% (onabotulinumtoxinA) S Steve 153331 reactions were not necessarily related to distant spread of toxin, of Clinically Significant Effects With Pre-Existing Neuromuscular — but may have resulted from the administration of BOTOX® to the Disorders (see Warnings and Precautions); and Dysphagia and Pocket Card l One 21-gauge, 2-inch needle site of injection and/or adjacent structures. In several of the cases, Breathing Difficulties (see Warnings and Precautions). Studio let and ﬁ in review M to still are Michelle on vendor by done waiting le; adjustments Creep print. not do lines ) Die (for reconstitution) patients had pre-existing dysphagia or other significant disabilities. Chronic Migraine ® There is insufficient information to identify factors associated with an This pocket card is a reference guide for BOTOX (onabotulinumtoxinA) The most frequently reported adverse reactions following injection injection sites for Chronic Migraine patients. The reconstitution l One 5-mL syringe increased risk for adverse reactions associated with the unapproved of BOTOX® for chronic migraine include neck pain (9%), headache ® ® materials, dilution table, and Injection Paradigm are highlighted for uses of BOTOX. The safety and effectiveness of BOTOX for (5%), eyelid ptosis (4%), migraine (4%), muscular weakness (4%), unapproved uses have not been established. quick reference. l Four 1-mL tuberculin syringes musculoskeletal stiffness (4%), bronchitis (3%), injection-site pain (for injection) Hypersensitivity Reactions (3%), musculoskeletal pain (3%), myalgia (3%), facial paresis (2%), Serious and/or immediate hypersensitivity reactions have been hypertension (2%), and muscle spasms (2%). Indication reported. These reactions include anaphylaxis, serum sickness, Chronic Migraine l At least four 30-gauge, 0.5-inch Post Marketing Experience BOTOX® for injection is indicated for the prophylaxis of headaches urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, There have been spontaneous reports of death, sometimes needles (for injection) further injection of BOTOX® should be discontinued and appropriate in adult patients with chronic migraine (≥ 15 days per month with associated with dysphagia, pneumonia, and/or other significant headache lasting 4 hours a day or longer). medical therapy immediately instituted. One fatal case of anaphylaxis debility or anaphylaxis, after treatment with botulinum toxin. There l One 10-mL single-use vial of has been reported in which lidocaine was used as the diluent, and have also been reports of adverse events involving the cardiovascular Important Limitations preservative-free, 0.9% consequently the causal agent cannot be reliably determined. system, including arrhythmia and myocardial infarction, some with Safety and effectiveness have not been established for the prophylaxis Q/C Check: Q/C Size: Print Page sodium chloride (saline) Increased Risk of Clinically Significant Effects With Pre-Existing fatal outcomes. Some of these patients had risk factors including of episodic migraine (14 headache days or fewer per month) in 7 Mgr: Prod Description: Neuromuscular Disorders cardiovascular disease. The exact relationship of these events to the placebo-controlled studies. l Alcohol swabs for cleaning the Individuals with peripheral motor neuropathic diseases, amyotrophic botulinum toxin injection has not been established. IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING rubber stoppers on the saline and lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia DRUG INTERACTIONS gravis or Lambert-Eaton syndrome) should be monitored when given ® BOTOX® vials Co-administration of BOTOX and aminoglycosides or other agents WARNING: DISTANT SPREAD OF TOXIN EFFECT botulinum toxin. Patients with neuromuscular disorders may be at interfering with neuromuscular transmission (eg, curare-like Postmarketing reports indicate that the effects of BOTOX® and all increased risk of clinically significant effects including generalized compounds) should only be performed with caution as the effect l Gauze pads botulinum toxin products may spread from the area of injection to muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe of the toxin may be potentiated. Use of anticholinergic drugs after produce symptoms consistent with botulinum toxin effects. These dysphagia, and respiratory compromise from therapeutic doses of administration of BOTOX® may potentiate systemic anticholinergic ® may include asthenia, generalized muscle weakness, diplopia, ptosis, l 1 pair of gloves BOTOX (see Warnings and Precautions). effects. The effect of administering different botulinum neurotoxin dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing Dysphagia and Breathing Difficulties products at the same time or within several months of each other is TbldO difficulties. These symptoms have been reported hours to weeks after Michelle M Update Cover Injection Workbook Treatment with BOTOX® and other botulinum toxin products can result unknown. Excessive neuromuscular weakness may be exacerbated l Hazardous medical waste container injection. Swallowing and breathing difficulties can be life threatening, in swallowing or breathing difficulties. Patients with pre-existing by administration of another botulinum toxin prior to the resolution and there have been reports of death. The risk of symptoms is probably swallowing or breathing difficulties may be more susceptible to these of the effects of a previously administered botulinum toxin. Excessive greatest in children treated for spasticity, but symptoms can also occur complications. In most cases, this is a consequence of weakening weakness may also be exaggerated by administration of a muscle in adults treated for spasticity and other conditions, particularly in of muscles in the area of injection that are involved in breathing or relaxant before or after administration of BOTOX®. those patients who have an underlying condition that would predispose oropharyngeal muscles that control swallowing or breathing (see Please see accompanying full Prescribing Information including them to these symptoms. In unapproved uses, including spasticity in Boxed Warning). Ensure you have received authentic Boxed Warning and Medication Guide. children, and in approved indications, cases of spread of effect have BOTOX® from Allergan. Look for the Human Albumin and Transmission of Viral Diseases References: been reported at doses comparable to those used to treat cervical holographic film on the vial; “Allergan” This product contains albumin, a derivative of human blood. Based 1. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method dystonia and spasticity and at lower doses. should appear within the rainbow lines. on effective donor screening and product manufacturing processes, it of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and carries an extremely remote risk for transmission of viral diseases. A effective treatment paradigm based on the PREEMPT clinical program. Headache. theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is 2010;50(9):1406-1418. 2. BOTOX® Prescribing Information, January 2016. also considered extremely remote. No cases of transmission of viral Please see additional Important diseases or CJD have ever been reported for albumin. © 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners. BOTOXMedical.com/ChronicMigraine Safety Information about 1-800-44-BOTOX APC54GS16 160853 BOTOX® inside. Date: Revision #: Brand Lead:Brand Final Output:

IMPORTANT SAFETY INFORMATION (continued) CONTRAINDICATIONS 02/25/2016 collect Omar H Omar 144 + PMS CMYK BOTOX® 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. WARNINGS AND PRECAUTIONS Lack of Interchangeability Between Botulinum Toxin Products The potency Units of BOTOX® are specifi c to the preparation and assay method utilized. They X are not interchangeable with other preparations of botulinum toxin products and, therefore, Comp Lite Mech Mechanical Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specifi c assay method. Spread of Toxin Effect See Boxed Warning. No defi nitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for Please see Important Safety Information including Boxed Warning about BOTOX®

2 chronic migraine at the labeled dose have been reported. throughout this brochure. 43

on following pages. following on BOTOX about Information Safety Important additional see Please