Overview

This Web Site, located at onzetra.com (the "Web Site"), is owned and operated by Avanir Pharmaceuticals, Inc. ("Avanir"). We recognize the importance of privacy to you and the other users of this Web Site. As a result, we have instituted this Web Site Privacy Policy, which applies only to the operation of the Web Site. Avanir is providing this notice to explain our online information practices. This Privacy Policy applies only to the use and collection of data collected by us on this Web Site and does not apply to any other data collected by us online or off-line.

In general, you may visit our Web Site and view its content while remaining anonymous by not providing any personal information. By using the Web Site, you agree to the terms of this Privacy Policy and, if you provide us your personal information, you consent to the collection, use, and disclosure of your information as described in this Privacy Policy. If you do not agree with this policy, please do not provide us any information and do not use the Web Site.

As used in this Privacy Policy, "we" includes Avanir and any third-party vendors we hire to assist in the administration of the Web Site and/or the processing or handling of customer information. These vendors are required to maintain the confidentiality of the user information and are prohibited from using it for any purpose other than as described in this Privacy Policy.

Web Site purpose

This Web Site is a resource for information about ONZETRA® Xsail® (sumatriptan nasal powder) for physicians and consumers.

Collection of nonpersonal information

Avanir may collect nonpersonally identifiable information about how you use this Web Site using analysis technologies. These analysis technologies may be provided by third parties. Information that might be collected using these technologies includes, for example, the pages you visit on this Web Site, the paths you take within this Web Site, and the length of time that you spend on this Web Site. We use this information in the aggregate in order to better understand how to improve the quality of this Web Site.

As is common among Internet site operators, the operator of this Web 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 log collect statistical data that is generated by your computer when it visits this Web Site, such as the type of Web browser and operating system used to access the Web Site, the domain name of your Internet service provider, the date and time you access this Web Site, and the pages you visit. This Web Site uses this nonpersonally identifying Web server log information for a variety of purposes. Some of these purposes include: system administration; examination of overall traffic trends on this Web Site; troubleshooting; and the collection of broad demographic information about users of this Web 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.

Cookies

Like many Web sites, this Web 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 Web site. Cookies are capable of storing many types of data and may be placed on your browser by Avanir. Information gathered from cookies in this way is only used on an aggregate basis. We may also use cookies to store preferences; record session information; develop information about Web Site visitors' preferences and interests; record past activity at a Web Site in order to provide better service when you return to our Web 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 personally identifiable information from this Web Site, unless you voluntarily agree to enter the information. 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 Web Site may not work properly if you refuse cookies.

Use of information

We may collect personally identifying information that you affirmatively provide to us, including, without limitation, your name, address, telephone number, and/or e-mail address and, if you are a physician, your specialty and certain generic patient and practice information.

From time to time, we may use this information to better understand your needs and how we can improve our products and services. When you voluntarily give us your personal contact information, we may use this information to contact you directly.

We may use this information to provide you with information or as otherwise disclosed to you on the registration Web page when you submit your information to us, including, without limitation, receiving announcements, information, and newsletters. In addition, your personally-identifying information may be shared with third parties (i) as required by law, such as when compelled by subpoena or court order, (ii) to protect and defend the rights of Avanir and its employees, the Web Site, or the users of the Web Site, (iii) as incident to a sale, merger, reorganization, dissolution, bankruptcy, or similar event, (iv) under circumstances we believe reasonably necessary to protect the personal safety of users of Avanir products, this Web Site, or the public, (v) to complete any transaction initiated by you on this Web Site or to provide services or information to you, or (vi) as is otherwise described in this Privacy Policy. The information you provide will be maintained for a commercially reasonable period of time by Avanir for administrative, liability, and archival purposes.

We may use this information to provide you with information or as otherwise disclosed to you on the registration Web page when you submit your information to us, including, without limitation, receiving announcements, information, and newsletters. In addition, your personally-identifying information may be shared with third parties (i) as required by law, such as when compelled by subpoena or court order, (ii) to protect and defend the rights of Avanir and its employees, the Web Site, or the users of the Web Site, (iii) as incident to a sale, merger, reorganization, dissolution, bankruptcy, or similar event, (iv) under circumstances we believe reasonably necessary to protect the personal safety of users of Avanir products, this Web Site, or the public, (v) to complete any transaction initiated by you on this Web Site or to provide services or information to you, or (vi) as is otherwise described in this Privacy Policy. The information you provide will be maintained for a commercially reasonable period of time by Avanir for administrative, liability, and archival purposes.

Comments, e-mails, suggestions, or other communications sent by you to us are deemed to be nonconfidential (except with regard to personally identifying information included therein), and we are free to use or distribute them in any way without compensation to the author, sender, or any other party.

We might also merge the information collected through off-line sources with data collected through our Web Site into the same database.

Links

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

Security of data stored by Avanir

Avanir has security measures in place to protect the loss, misuse, and alteration of the 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 should consider any communication that you transmit to Avanir (such as personally identifiable or other data, questions or answers, comments, or suggestions) as nonconfidential and agree that Avanir shall not be liable or responsible if any information about you is intercepted and used by an unintended recipient.

Collection of personally identifying information from or about children

This Web Site is not intended or designed to attract children under the age of 18. Avanir uses reasonable efforts not to collect, use, or disclose personally identifiable information from children under the age of 18.

International users

Personal data that you have voluntarily entered electronically is delivered to servers located in the United States. By using this Web Site, you consent to the transfer of this personal and nonpersonal data and to our use of such personal and nonpersonal data as outlined in this Privacy Policy.

California users

We do not disclose your personal information to third parties for the third parties' direct marketing purposes, as governed by California Civil Code 1798.83.

Access or correction of your personally identifying information; opt out from receiving communications.

You may always contact us to remove or update personally identifiable information from our database. To request a copy of your personally identifiable information stored by Avanir, please send an e-mail containing your request to privacy@avanir.com. You must provide your full name, e-mail address, and any other information reasonably requested by Avanir. You may then correct or delete such information using the procedures specified in the e-mail message.

Changes to this Privacy Policy

Avanir may, from time to time in its sole discretion, change or modify this Privacy Policy. Any changes or modification will be effective upon posting of the revisions at www.onzetra.com. Avanir may post changes or modifications to referenced policies and guidelines without your approval, and may determine whether and when any such changes apply to you. Your use of the Web Sites or the services following our posting of any changes will constitute your acceptance of such changes. Should you not wish to be bound by the modified Privacy Statement, do not use the Web Sites or the services.

This Privacy Policy is effective as of May 9, 2016.

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@onzetra.com.

Tap for Safety Information

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?
ONZETRA Xsail may cause serious side effects, including:

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?

ONZETRA Xsail may cause serious side effects, including:

  • Heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
  • Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • Stomach and intestinal problems (gastrointestinal and colonic ischemic events)
  • Problems with blood circulation to your legs and feet (peripheral vascular ischemia)
  • Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
  • Medication overuse headaches. Some people who use ONZETRA Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with ONZETRA Xsail
  • Serotonin syndrome, a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; or nausea, vomiting, or diarrhea
  • Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of ONZETRA Xsail are abnormal taste, discomfort of your nose or throat, runny nose, and stuffy nose. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Who should not take ONZETRA Xsail?
Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you:

  • Have heart problems or a history of heart problems
  • Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • Have uncontrolled high blood pressure
  • Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor
  • Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)
  • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications. Ask your doctor for a list of these medicines if you are not sure
  • Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking ONZETRA Xsail
  • Have severe liver problems
  • Have an allergy to sumatriptan, the medicine in ONZETRA Xsail, or any of the components in ONZETRA Xsail

What should I tell my healthcare provider before taking ONZETRA Xsail?
Before you take ONZETRA Xsail, tell your doctor about all your medical conditions and all the medicines you take, including prescription medicines, especially antidepressants, and all over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ONZETRA Xsail?
ONZETRA Xsail can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.

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