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Please note:  As Avanir manufactures and sells its products only within the United States, its websites and mobile applications are directed at and intended for use by individuals within the United States only.

Privacy Policy

Overview

Avanir Pharmaceuticals, Inc. (“Avanir,” “we,” “us,” or “our”) is providing this Privacy Policy to explain our online information practices regarding our websites and mobile applications (“Site(s)”). This Privacy Policy applies only to the use and collection of data by us on the Sites and does not apply to any other data collected by us online or offline.

The Effective Date of these Terms is set forth at the top of this webpage. Avanir reserves the right to modify this Privacy Policy at any time by posting a new or updated privacy policy on the Site. Modifications may be posted on the Site, and any such changes or modifications will be effective immediately upon posting of the revisions on the Site. If any modifications materially change this Privacy Policy, we will provide you with advance written notice in the form of an email to the email address you provided or in a banner message on the Site. Please review the Privacy Policy periodically for changes; all revision dates will be listed at the bottom of this policy.  By accessing the Site, you indicate your agreement to and acceptance of the terms of this Privacy Policy, and consent to the collection, retention, and use of the information you provide consistent with this Privacy Policy, as amended from time to time.  If you do not agree with this policy, please do not provide us with any information and do not use the Site. The amended Privacy Policy supersedes all previous versions of the Privacy Policy.

Information We Collect and How We Use the Information

On this site, we may collect personally identifying information (“PII”) that you affirmatively provide to us, including, by way of example, your name, address, telephone number, and/or email address.  If you are a physician, we may collect additional information about you such as your National Provider Identifier and/or state medical license number, your specialty, and certain generic information regarding your practice and patients that does not include patient protected health information or other PII regarding such patients (by way of example but not limitation, we may ask whether your practice includes the treatment of certain types of conditions).

From time to time, we may use this information to better understand your needs and how we can improve our products and services.  If you give us your personal contact information, we may use such information to contact you directly.  If you prefer not to be contacted, please send an email with your written request to opt-out@avanir.com or follow the opt-out instructions included in our email communications.

We may use PII as described on the Site through which you submit your information as well as to provide you with Avanir-related information such as announcements, information, and newsletters.  In addition, your PII may be shared with third parties, including (i) our affiliates; (ii) third-party vendors we hire to assist in the administration of the Site and/or the processing or handling of customer information (such vendors are required to maintain the confidentiality of user information and are prohibited from using it for any purpose other than as described in this Privacy Policy); (iii) as required by law, such as when compelled by subpoena or court order, (iv) to protect and defend the rights of Avanir and its employees, the Sites, or the users of the Sites; (v) as incident to a sale, merger, reorganization, dissolution, bankruptcy, or similar event; (vi) under circumstances we believe reasonably necessary to protect the personal safety of users of Avanir products, this Site, or the public; (vii) to complete any transaction initiated by you on this Site or to provide services or information to you; or (viii) as is otherwise described in this Privacy Policy or to the extent that you otherwise consent to in writing.  Avanir will maintain information you provide pursuant to its records retention policy.

We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of our programs and advertisements.

Comments, emails, suggestions, or other communications you send to Avanir are deemed to be non-confidential (except with regard to any PII included therein) and free to be used or distributed by Avanir in any way without compensation or attribution to you or any other party, pursuant to the terms provided for “User Content” and “Feedback” under our Terms and Conditions.

We also may collect non-PII about how you use this Site for, among other reasons, the operation and improvement of the Sites.  Non-PII is data in a form that does not, on its own, permit direct association with you, and includes but is not limited to technical information about how you access the Site, including but not limited to browser information, operating system, unique device identifiers, IP address, referring site, visit metrics, action metrics, page view metrics, search metrics, and others.  This information may be collected through technologies provided by third parties.  Information that might be collected using these technologies includes, for example, the pages you visit on this Site, the paths you take within this Site, and the length of time that you spend on this Site.  We use this information in the aggregate to better understand how to improve the quality of this Site.

As is common among internet site operators, the operator of this Site maintains web server logs.  Web servers automatically identify your computer by its IP address and collect that information in its web server logs.  An IP address is a number that is automatically assigned to your computer by your internet service provider whenever you log onto the World Wide Web or “surf” the Internet.  The Avanir web server logs collect statistical data that is generated by your computer when it visits this Site, such as the type of web browser and operating system used to access the Site, the domain name of your internet service provider, the date and time you access this Site, and the pages you visit.  This Site uses this non-personally identifying Web server log information for a variety of purposes.  Some of these purposes include: system administration; examination of overall traffic trends on this Site; troubleshooting; and the collection of broad demographic information about users of this Site.  No personally identifiable information is contained in these web server logs.  The log files may be purged periodically, in our discretion, to maximize space on the server or for other business reasons.

Cookies

Like many websites, this Site also uses a technology called “cookies.”  A cookie is a small text file that a web server gives your browser to store on your computer when you access a website.  Cookies store many types of data and may be placed on your browser by Avanir.  We may also use cookies to store preferences; record session information; develop information about Site visitors’ preferences and interests; record past activity at a Site in order to provide better service when you return to our Site; or customize web page content based on information you voluntarily provide.

In all cases in which cookies are used, however, Avanir will not use the cookie to collect PII from this Site unless you voluntarily agree to provide the PII.  Most web browsers are set up to accept cookies.  You can, however, reset your browser to refuse all cookies or to indicate when a cookie is being sent.  Note, however, that some portions of this Site may not work properly if you refuse cookies.

Links

The Site may contain links to third-party websites.  Please recognize that we do not control these third-party websites and this Privacy Policy will not apply to those websites.  You should consult each applicable privacy policy before using another linked website.  Avanir is not responsible for the privacy practices or the content included on third-party websites.

Do Not Track

Because we may use the information that we collect through the Site in the ways described in this Privacy Policy, we do not respond to "Do Not Track" requests or other similar mechanisms.

Security of data stored by Avanir

Avanir has security measures in place to protect the loss, misuse, and alteration of information under our control.  While we make reasonable efforts to ensure the integrity and security of our network and systems, we cannot guarantee that our security measures will prevent third parties from illegally obtaining this information.  You agree and acknowledge that Avanir shall not be liable or responsible if any information about you is intercepted, accessed, and/or used by an unintended recipient. If you have reason to believe that the security of your communications or PII has been compromised, please notify us immediately at: privacy@avanir.com.

Collection of PII from or about children

This Site is not intended or designed to attract children under the age of 13.  If you are 13 years old or older but under the age of 18, you may only use the Site only with the consent of your parent or legal guardian.

We do not knowingly collect, use, or disclose PII from persons under age 13.  If we learn that we have collected PII of a user under the age of 13, we will take steps to delete the information as soon as possible.

If you are a parent and you think we have inadvertently collected PII from your child who is under 13 (or under 18), please send an email to privacy@avanir.com to request that we delete his or her information from our records.

Storage and use of information in the United States

PII you voluntarily entered into one or more Sites is delivered to servers located in the United States.  By using this Site, you consent to our use of your PII and non-PII as outlined in this Privacy Policy.

Your privacy rights; access to or correction of your personally identifying information

If you have any questions about this Privacy Policy or any disclosure of personal information to third parties for direct marketing purposes, or if you would like to request a copy of your PII stored by Avanir, please send an email containing your request to privacy@avanir.com. Your request must include your full name and email address.

In addition, if you no longer wish to receive communications from us, you may opt out at any time by notifying us at opt-out@avanir.com.

Contact Us

If you have any questions regarding our Privacy Policy, contact us at privacy@avanir.com.

Important Safety Information & Indication

ONZETRA Xsail is contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal’s angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack (TIA), or hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, consider administering first dose of ONZETRA Xsail in a medically-supervised setting
  • Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ONZETRA Xsail if these disturbances occur
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
  • Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
  • Other Vasospasm Reactions: 5-HT1 agonists, including ONZETRA Xsail, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ONZETRA Xsail
  • Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
  • Serotonin Syndrome: May occur with triptans, including ONZETRA Xsail, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ONZETRA Xsail if serotonin syndrome is suspected
  • Increases in Blood Pressure: Increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ONZETRA Xsail
  • Anaphylactic Reactions: Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ONZETRA Xsail is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
  • Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ONZETRA Xsail should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold

Indication/Limitations of Use

ONZETRA® Xsail® (sumatriptan nasal powder) is indicated for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail should only be used where a clear diagnosis of migraine has been established. ONZETRA Xsail is not indicated for the prevention of migraine attacks or for other types of headaches, including cluster headache. 

Important Safety Information

Contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal’s angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack (TIA), or hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, consider administering first dose of ONZETRA Xsail in a medically-supervised setting
  • Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ONZETRA Xsail if these disturbances occur
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
  • Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
  • Other Vasospasm Reactions: 5-HT1 agonists, including ONZETRA Xsail, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ONZETRA Xsail
  • Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
  • Serotonin Syndrome: May occur with triptans, including ONZETRA Xsail, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ONZETRA Xsail if serotonin syndrome is suspected
  • Increases in Blood Pressure: Increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ONZETRA Xsail
  • Anaphylactic Reactions: Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ONZETRA Xsail is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
  • Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ONZETRA Xsail should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold

ADVERSE REACTIONS

In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals at 1-844-ONZETRA (1-844-669-3872) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional Important Safety Information about ONZETRA, please see full Prescribing Information, including Instructions for Use.