Terms of Use

1. Terms

By accessing the MyTOSYMRA.com or TOSYMRA.com websites provided by Upsher-Smith Laboratories, LLC (“Upsher-Smith”), you are agreeing to be bound by each of the website’s Terms and Conditions of Use, which constitute the agreement that governs your use of either website. You should carefully read these Terms and Conditions of Use before using either website. If you do not agree to be bound by these terms of use, you should immediately exit the website.

2. User Eligibility; Consent

These websites are provided by Upsher-Smith solely for use within the United States. Upsher-Smith makes no representations or warranty that the websites are usable and accurate outside of the United States. The websites are not intended for use by children under the age of 13. Upsher-Smith will not knowingly collect information about children under the age of 13 and will otherwise comply with the Children’s Online Privacy Act. Any user of the websites should monitor the use of the website by children under their care and ensure that those children are aware of the dangers of providing information about themselves over the Internet.

3. License and Site Access

Upsher-Smith hereby grants you permission to access and make personal, non-commercial use of the websites. You may view, copy, print, and distribute limited quantities of material from the website, so long as the material is used by you solely for informational, non-commercial purposes. Your permission to access and use the websites will be deemed automatically to have been terminated, effective immediately, should you breach these Terms and Conditions of Use. Any rights not expressly granted to you by these Terms and Conditions of Use are expressly reserved by Upsher-Smith.

4. Intellectual Property

All intellectual property associated with either of these websites, including, without limitation, its content, trademarks, service marks, trade dress, and other proprietary intellectual property appearing on the website or referenced therein, are the sole property of Upsher-Smith. Any rights associated with any such item of intellectual property are retained by its owner and protected by applicable law. These Terms and Conditions of Use expressly prohibit any use of any intellectual property associated with the websites except as expressly specified in these Terms and Conditions of Use or elsewhere on each website.

5. Product and Service Information

The websites provide users with information regarding Upsher-Smith’s TOSYMRA product. Periodically, Upsher-Smith may add new features or information on the websites, all of which will be subject to these Terms of Use. You are encouraged to periodically review the current version of these Terms of Use. Upsher-Smith shall have no responsibility for errors of any kind in connection with either website. Errors and the consequences of those errors may include, without any limitation, any of the following: technical, typographical, or photographic errors. Upsher-Smith does not warrant that any of the materials on its website are accurate, complete, or current. Upsher-Smith may make changes to the materials contained on its website at any time without notice. Upsher-Smith does not, however, make any commitment to update the materials.

6. No Warranty

The websites (including any content or information contained within it), any other Upsher-Smith website, and any linked website, is provided “as is” and on an “as available” basis. AS TO THE SITE, AND TO ANY OTHER SUCH UPSHER-SMITH WEBSITE AND LINKED WEBSITE, TO THE FULLEST EXTENT PERMITTED BY LAW, UPSHER-SMITH EXPRESSLY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FIRMNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

You assume total responsibility for your use of the website and any linked website. Any material downloaded or otherwise obtained through your use of the website is so obtained at your own discretion and risk. Upsher-Smith will not be responsible for any damage to your computer system or loss of data that results from so obtaining any such material.

7. Limitation of Liability

IN NO EVENT SHALL UPSHER-SMITH, ITS RELATED ENTITIES, SUBSIDIARIES, JOINT VENTURES, PARTNERS, OFFICERS, DIRECTORS, OR EMPLOYEES BE LIABLE FOR ANY DIRECT, INDIRECT, COMPENSATORY, SPECIAL, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES WHICH MAY ARISE, DIRECTLY OR INDIRECTLY, FROM THE ACCESS TO THE MyTOSYMRA.com or TOSYMRA.com WEBSITES, FROM THE USE OF IT, FROM THE INABILITY TO USE IT, THROUGH THE AUTHORIZED DOWNLOADING OF ANY CONTENT (INCLUDING, WITHOUT LIMITATION, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE WEBSITE) OR IN CONNECTION WITH ANY VIRUSES, BUGS, ACTION OR INACTION OF ANY COMPUTER SYSTEM, TELEPHONE LINE, HARDWARE, SOFTWARE OR PROGRAM MALFUNCTION, OR ANY OTHER ERROR, FAILURE OR DELAY IN DATA TRANSMISSION OR NETWORK CONNECTION EVEN IF ADVISED OF THE POSSIBILITY OF THAT DAMAGE.

Upsher-Smith has no liability for the deletion of any communications or information collected, maintained, or transmitted by the websites or the failure to store any information, including personalized settings. Upsher-Smith has no liability with respect to any information posted by users on chat rooms, bulletin boards, or any other user forum.

8. Links

Upsher-Smith is not responsible for the contents of any sites linked to the MyTOSYMRA.com or TOSYMRA.com websites. The inclusion of any link does not imply endorsement by Upsher-Smith of the site. Use of any such linked website is at your own risk.

9. Site Terms of Use Modifications

Upsher-Smith may revise these Terms and Conditions of Use for the MyTOSYMRA.com or TOSYMRA.com websites at any time without notice. By using the websites you are agreeing to be bound by the then current version of these Terms and Conditions of Use.

10. Governing Law

Any claim relating to Upsher-Smith’s website shall be governed by the laws of the State of Minnesota without regard to its conflict of law provisions.

Privacy Policy

Your privacy is very important to us. The current privacy policy for Upsher-Smith may be viewed at www.upsher-smith.com/privacy-policy/.

Upsher-Smith is committed to conducting our business in accordance with these principles in order to ensure that the confidentiality of personal information is protected and maintained.

IMPORTANT SAFETY INFORMATION

TOSYMRA™ is contraindicated in patients with:

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

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.
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IMPORTANT SAFETY INFORMATION

TOSYMRA™ is contraindicated in patients with:

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

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.