Allergan respects your privacy and recognizes your need for appropriate protection and management of personally identifiable information you share with us (the phrases “personally identifiable information” means any information by which you can be identified, such as your name, address, telephone number, etc.). The purpose of this privacy statement is to inform you what personally identifiable information we may collect from you when you visit our Site, and how we use such information, and the choices you have regarding our use of, and your ability to review and correct, the information. As we may revise our privacy policies from time to time, you should therefore periodically visit this page to review the then current Privacy Statement.
How we collect information
In general, you can visit many of our Web pages without telling us who you are or revealing any personally identifiable information. We may track the Internet domain address from which people visit us and analyze this data for trends and statistics, but individual users will remain anonymous, unless you voluntarily tell us who you are.
There may be times at which we ask you to provide certain information about yourself, such as your name, address, telephone number, e-mail address, etc. Whether or not to provide such information is completely your own choice; Allergan collects only the personal information that you provide to us. But if you choose not to provide the information we request, you may be unable to access certain services, offers, and content on our Site.
Cookies
To enable Allergan to provide customized and personalized services, Allergan may use cookies to store and sometimes track information about you. A cookie is a small amount of data that is sent to your browser from a Web server and stored on your computer. Cookies, by themselves, do not tell us any personally identifiable information about you. However, if you choose to furnish the Site with personally identifiable information (such as your e-mail address), that information could be linked to the data stored in the cookie. Allergan reserves the right to change our use of cookies and our practices regarding linkage to personally identifiable information without any prior notification.
How we use the information we collect
We use the information we automatically receive from your Web browser to see which pages you visit within our Site. We can then develop statistics that are helpful to understanding how this Site is used by our visitors. This statistical data is interpreted by Allergan in its continuing effort to present the Site content that visitors are seeking in a format they find most helpful.
When Allergan receives personally identifiable information, we may use it for reasonable business purposes, such as contacting you, via e-mail or regular mail, to provide you with information we believe may be of interest. If you e-mail us, you are voluntarily releasing information to us. Your e-mail address will be used by Allergan to respond to you.
Third-party use of information
Allergan will not sell, share, or otherwise distribute your personally identifiable information to third parties except as provided herein. However, personally identifiable information may occasionally be transferred to third parties who act for or on behalf of Allergan, or in connection with the business of Allergan, for further processing in accordance with the purposes for which the data was originally collected. Where disclosure of personally identifiable information to a third party is likely or necessary, further explanation may be provided, where appropriate, at such collection points as to the intended use of the data. We require that such third parties protect the information and, where appropriate, we will contractually require them to process data transferred only for the purposes expressly authorized by Allergan.
Because of the nature of the Internet, we may transmit the information to another country, but within Allergan, for purposes other than direct marketing, such as for storage, or because of where our servers are located. We may also use it to investigate security breaches or cooperate with authorities pursuant to a legal matter. We may also remove all the personally identifiable information and use the rest for historical, statistical, or scientific purposes. This Site contains links to other sites. Be aware that Allergan is not responsible for the privacy practices of non-Allergan sites. We encourage you to review the privacy statements of any Web sites that you visit through a link on this Site.
Questions and comments
If you have any questions or comments about Allergan’s Privacy Policy or if you wish to review and correct your personally identifiable information held by Allergan, please contact us by clicking on the Contact Us link within the Site and by inserting the words “Privacy Policy” in the Subject line.
Indications
Cervical Dystonia
BOTOX® is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
Blepharospasm and Strabismus
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.
IMPORTANT SAFETY INFORMATION
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.
CONTRAINDICATIONS
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 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.
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.
Dysphagia and Breathing Difficulties in Treatment of Cervical Dystonia
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved (see Boxed Warning).
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®.
Corneal Exposure and Ulceration in Patients Treated with BOTOX® for Blepharospasm
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.
Retrobulbar Hemorrhages in Patients Treated with BOTOX® for Strabismus
During the administration of BOTOX® for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
ADVERSE REACTIONS
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).
Cervical Dystonia
The 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%).
Blepharospasm
The most frequently reported adverse reactions following injection of BOTOX® for blepharospasm include ptosis (21%), superficial punctate keratitis (6%), and eye dryness (6%).
Strabismus
The most frequently reported adverse events following injection of BOTOX® for strabismus include ptosis (15.7%) and vertical deviation (16.9%).
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.
DRUG INTERACTIONS
No formal drug interaction studies have been conducted with BOTOX® (onabotulinumtoxinA) for injection. Co-administration of BOTOX® and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
Please see BOTOX® full Prescribing Information (103 kb) including Medication Guide (25.5 kb)
© 2010 ALLERGAN / Terms of Use / Privacy / Contact Us ® marks owned by Allergan, Inc.
The information on this site is intended for US residents only.
No information in this site is provided with the intention to give medical advice or instructions on the accurate use of Allergan products. Allergan cannot answer unsolicited e-mails requesting personal medical advice; visitors should always consult a healthcare professional.
For additional BOTOX® information, please go to: https://hcp.botoxmedical.com/Pages/Home.aspx
APC22UD11
