Why Tosymra?

Different migraines require different approaches. Migraine is a debilitating disease that can be further complicated when certain symptoms are present.

How Can Tosymra Help?

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

If you suffer from any of the following migraines, Tosymra may be able to help:

What Makes Tosymra Different from Other Migraine Nasal Sprays

intravail-logo

Tosymra is the only migraine nasal spray that uses the science of Intravail.4-6

Intravail is an odorless, tasteless, non-toxic, non-irritating ingredient that enhances drug absorption across the nasal mucosa.

Intravail allows the sumatriptan to get into the blood stream quickly and efficiently without dripping down the throat into the gut.

Intravail is thought to facilitate paracellular absorption by transiently relaxing tight junction, allowing the sumatriptan access to systemic circulation, by passing the gut.

intravail-logo

Tosymra is the only migraine nasal spray that uses the science of Intravail.4-6

Intravail is an odorless, tasteless, non-toxic, non-irritating ingredient that enhances drug absorption across the nasal mucosa.

Intravail allows the sumatriptan to get into the blood stream quickly and efficiently without dripping down the throat into the gut.

Intravail is thought to facilitate paracellular absorption by transiently relaxing tight junction, allowing the sumatriptan access to systemic circulation, by passing the gut.

Do not use Tosymra if you have: heart problems or a history of heart problems; had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation. These are not all of the reasons you should not use Tosymra. See the Important Safety Information, and speak with your healthcare provider for more information about whether Tosymra is right for you.

References:
1) Top 10 migraine triggers and how to deal with them. American Migraine Foundation. https://americanmigrainefoundation.org/resource-library/top-10-migrainetriggers-and-how-todeal-withthem/. Published July 27, 2017. Accessed April 2024.  2) Lipton RB, et al. Headache. 2019 Sep;59(8):1310-1323.  3) Newman LC. Headache. 2013 Jun;53 Suppl 1:11-16.  4) Maggio ET. J Excipients and Food Chem. 2014;5(2):100-112.  5) Maggio ET. Expert Opin Drug Deliv. 2006;3(4):529-539. 6) Maggio ET, et al. Drug Deliv Transl Res.2013;3(1):16-25.
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Do not take Tosymra® if you have hemiplegic migraines or basilar migraines or to treat cluster headache.

IMPORTANT SAFETY INFORMATION
Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or 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 or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • 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 provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • 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 one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: 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 even in people 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 provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

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