BOTOX® Severe Sweating | Info Physicians :: BOTOX® Information for Physicians

This Information Is Intended for US Healthcare Professionals Now you can help patients living with severe axillary hyperhidrosis that is inadequately managed with topical agents. PROVEN EFFICACY 55% of BOTOX^® patients achieved primary statistical study endpoint (P <.001 vs 6% placebo)¹ LASTING DURATION 201-day median duration of response¹ COMPELLING RESULTS 81% of BOTOX^® patients achieved at least a 50% reduction in axillary sweating measured gravimetrically at 4 weeks post-injection (P<.001 vs 41% placebo) (95% CI)² (clinical significance unknown) HYPERHIDROSIS DISEASE SEVERITY SCALE (HDSS) A 4-point scale for categorizing the severity of primary axillary hyperhidrosis³

REFERENCE

BOTOX^® Prescribing Information.
Data on file. Allergan, Inc.; Pivotal clinical trial, Study 016.
Data on file, Allergan, Inc.; Pivotal clinical trials, Study 505 and Study 506

HOW MUCH SWEAT IS TOO MUCH SWEAT?

Do you often wonder if you sweat too much? Take our test and find out if you have severe underarm sweating.

BOTOX^® NEUROTOXIN IS APPROVED BY THE FDA

BOTOX^® is approved by the FDA to treat the symptoms of severe underarm sweating when topical medicines do not work well enough. It is not known whether BOTOX® is safe or effective for severe sweating anywhere other than your armpits.

FIND A TRAINED DERMATOLOGIST

Locate a specialist near you who is trained to treat severe underarm sweating.

BOTOX^® (onbotulinumtoxinA) is injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older. It is not known whether BOTOX^® is safe or effective for severe sweating anywhere other than your armpits. 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 (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

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 severe underarm sweating. Do not take BOTOX^® if you: are allergic to any of the ingredients in BOTOX^® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc^®(rimabotulinumtoxinB), Dysport^® (abobotulinumtoxinA), or Xeomin^® (incobotulinumtoxinA); have a skin infection at the planned injection site. The dose of BOTOX^® is not the same as, or comparable to, another botulinum toxin product. Serious and or immediate allergic reactions have been reported. These reactions include itchy rash, swelling, and shortness of breath. Tell your doctor or get medical help right away if you experience any such symptoms, further injection of BOTOX^® should be discontinued. Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX^®. Human albumin and spread of viral diseases
BOTOX^® contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg Creutzfeld-Jakob Disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin. Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (It is not known if BOTOX^® can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX^® passes into breast milk). Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX^® with certain other 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. Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc^®, Dysport^®, or Xeomin^® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners). Other side effects of BOTOX^® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; urinary tract infection and/or inability to empty your bladder on your own (in people being treated for urinary incontinence). For more information refer to the Medication Guide or talk with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see BOTOX^® full Product Information including Boxed Warning and Medication Guide. Full Product Information, including Medication Guide has been provided to your doctor. © 2012 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc. Dysport is a registered trademark of Ipsen Biopharm Limited.
Myobloc is a registered trademark of Solstice Neurosciences, Inc.
Xeomin is a registered trademark of Merz Pharma GmbH & Co. KGaA.

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BOTOX^® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. The safety and effectiveness of BOTOX^® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX^® for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. Safety and effectiveness of BOTOX^® have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18. Distant Spread of Toxin Effect
Postmarketing 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, 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 in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses. 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. Lack of Interchangeability between Botulinum Toxin Products The 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. Spread of Toxin Effect See Boxed Warning. 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 Reactions Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX^® should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined. Pre-Existing Neuromuscular Disorders Individuals 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^®. The following adverse reactions to BOTOX^® for injection are discussed in greater detail in the following sections: Spread of Toxin Effect (see Boxed Warning); Hypersensitivity Reactions (see Contraindications and Warnings and Precautions); Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity (see Warnings and Precautions). Primary Axillary Hyperhidrosis The most frequently reported adverse events (3 - 10% of adult 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. Post Marketing Experience There 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. Please see BOTOX^® full Prescribing Information including Medication Guide. © 2010 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan, Inc.

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