Using Tosymra

Tosymra is convenient and easy-to-use.

Tosymra is an Acute Migraine Treatment that Offers:

•  Fine, mist-like spray

•  Discreet size

•  Single-use device

•  No priming required

Tosymra is an Acute Migraine Treatment that Offers:

Fine, mist-like spray

Discreet size

Single-use device

No priming required

Simple Three-Step Process

Step 1

While sitting upright, gently blow the nose. Press one nostril with a finger to keep it closed.

Step 1

While sitting upright, gently blow the nose. Press one nostril with a finger to keep it closed.

Step 2

Hold the device upright, insert half of the spray nozzle into the open nostril, angling it slightly outward toward the outside of the nostril (not straight up).

Step 2

Hold the device upright, insert half of the spray nozzle into the open nostril, angling it slightly outward toward the outside of the nostril (not straight up).

Step 3

While keeping the device in the nose, tilt head back slightly. This will allow the medicine to go into the nasal passage without dripping out.

Slowly breathe through the nose and press the device plunger upward to release the spray. While keeping the head upright, gently breathe in through the nose and breathe out through the mouth for 10 to 20 seconds.

Step 3

While keeping the device in the nose, tilt head back slightly. This will allow the medicine to go into the nasal passage without dripping out.

Slowly breathe through the nose and press the device plunger upward to release the spray. While keeping the head upright, gently breathe in through the nose and breathe out through the mouth for 10 to 20 seconds.

Instructions for Use

Watch the Instructions for Use video to learn how to use Tosymra.

Please see Important Safety Information; full Prescribing Information, including Patient Information; and Instructions for Use.

How it Works

Tosymra is formulated with Intravail technology to help the medication be absorbed into the bloodstream so it can work quickly. It works as fast as an injection, providing migraine pain relief in as little as 10 minutes for some patients with just one spray (13% vs. 5% for placebo).1-3

Efficacy of Tosymra is based on relative bioavailability to subcutaneous sumatriptan at a dose of 4 mg. In a clinical study, this dose of sumatriptan resulted in 57% of patients achieving pain relief at 2 hours vs. 21% for placebo.

*Time to onset and degree of pain relief varies by patient.
References:
1) Tosymra [package insert]. Chatham, NJ: Tonix Medicines, Inc, 2023. 2) Mathew NT, et al. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276. 3) Wendt J, et al. A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults. Clinical Therapeutics. 2006;28(4):517-526.
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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.