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

What important information should I know about TOSYMRA?

TOSYMRA can cause serious side effects, including: heart attack and other heart problems, which may lead to death. Stop using TOSYMRA and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

TOSYMRA is not for people with risk factors for heart disease (high blood pressure, high cholesterol levels, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Who should not use TOSYMRA?

Do not use TOSYMRA if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your healthcare provider
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare provider if you are not sure if your medicine is listed above
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure
  • an allergy to sumatriptan or any of the ingredients in TOSYMRA

What should I tell my healthcare provider before taking TOSYMRA?

Tell your healthcare provider about all of your medical conditions, and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using TOSYMRA?

TOSYMRA 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.

What are possible side effects of TOSYMRA?

TOSYMRA may cause serious side effects including:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in 1 or both legs or feet
  • increased blood pressure including a sudden severe increase (hypertensive crisis) even if you have no history of high blood pressure
  • medication overuse headaches. Some people who use too much migraine medicine, such as TOSYMRA, for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with TOSYMRA
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using TOSYMRA, especially if TOSYMRA is used with anti-depressant medicines called SSRIs or SNRIs
    • Call your healthcare provider 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; or trouble walking
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of TOSYMRA include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TOSYMRA. For more information, ask your healthcare provider or pharmacist.

This is the most important information to know about TOSYMRA but is not comprehensive. For more information, talk to your healthcare provider and read the Patient Information and Instructions for Use for TOSYMRA. You can also visit www.upsher-smith.com or call 1-888-650-37891-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

What is TOSYMRA used for?

TOSYMRA is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

TOSYMRA is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. TOSYMRA is not used to treat cluster headaches.

TOSYMRA is not used to prevent or decrease the number of migraines you have. It is not known if TOSYMRA is safe and effective in children under 18 years of age.

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IMPORTANT SAFETY INFORMATION

What important information should I know about TOSYMRA?

TOSYMRA can cause serious side effects, including: heart attack and other heart problems, which may lead to death. Stop using TOSYMRA and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

TOSYMRA is not for people with risk factors for heart disease (high blood pressure, high cholesterol levels, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Who should not use TOSYMRA?

Do not use TOSYMRA if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your healthcare provider
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare provider if you are not sure if your medicine is listed above
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure
  • an allergy to sumatriptan or any of the ingredients in TOSYMRA

What should I tell my healthcare provider before taking TOSYMRA?

Tell your healthcare provider about all of your medical conditions, and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using TOSYMRA?

TOSYMRA 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.

What are possible side effects of TOSYMRA?

TOSYMRA may cause serious side effects including:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in 1 or both legs or feet
  • increased blood pressure including a sudden severe increase (hypertensive crisis) even if you have no history of high blood pressure
  • medication overuse headaches. Some people who use too much migraine medicine, such as TOSYMRA, for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with TOSYMRA
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using TOSYMRA, especially if TOSYMRA is used with anti-depressant medicines called SSRIs or SNRIs
    • Call your healthcare provider 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; or trouble walking
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of TOSYMRA include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TOSYMRA. For more information, ask your healthcare provider or pharmacist.

This is the most important information to know about TOSYMRA but is not comprehensive. For more information, talk to your healthcare provider and read the Patient Information and Instructions for Use for TOSYMRA. You can also visit www.upsher-smith.com or call 1-888-650-37891-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

What is TOSYMRA used for?

TOSYMRA is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

TOSYMRA is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. TOSYMRA is not used to treat cluster headaches.

TOSYMRA is not used to prevent or decrease the number of migraines you have. It is not known if TOSYMRA is safe and effective in children under 18 years of age.