Tosymra®

The first and only triptan nasal spray with Intravail® technology, which is designed to enhance the medicine's absorption

Image for TOSYMRA (Sumatriptan Nasal Spray) 10 mg

Not actual size.

Formulation

Not actual size.

Was absorbed up to 8x faster than Imitrex® nasal spray in a clinical study*

TOSYMRA is absorbed through the nose, which can help when a migraine upsets your stomach.

*The significance of this data is not fully understood. It does not reflect how well TOSYMRA works.

Results

For when fast relief matters

Delivers the same amount of medicine as a 4 mg sumatriptan injection. In a clinical study using this dose of sumatriptan injection, patients experienced:

2-hour

Migraine relief 2 hours after dosing*

57% of patients experienced relief by 2 hours (vs 21% with placebo).
10-minute

Fast relief in as little as 10 minutes*

13% of patients reported pain relief as early as 10 minutes (vs 5% with placebo).

*Relief meant patients’ pain improved from moderate or severe to mild or no pain after taking their medication—without needing any additional (rescue) medicine.

Side Effects

The most common side effects
of TOSYMRA (sumatriptan nasal spray) include:

tingling or numbness, dizziness, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, application site (nasal) reactions and abnormal taste and throat irritation.

In a 6-month study, about 46% of patients treated with TOSYMRA reported local irritative symptoms, the most common of which were burning sensations in the nose, abnormal taste and throat irritation (about 0.5% were severe). Fewer than 3% of TOSYMRA doses caused triptan-related side effects, such as:

  • Fluttering, fast, or pounding heartbeat
  • Nausea
  • Chest discomfort
  • Dizziness
  • Fatigue
  • Tingling or numbness
  • Shortness of breath
  • Throat irritation or tightness

However, most of these side effects were mild.

Not an actual patient. For illustrative purposes only.

How to Use

Only one device needed to deliver a full dose

Read the Instructions for Use before you start to use TOSYMRA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Labeled diagram of Tosymra 10 mg nasal spray device: tip (nose), spray nozzle, plunger (thumb). Not actual size.

Not actual size.

Step-by-step how to use TOSYMRA

Illustration of person blowing nose to clear nostrils before using Tosymra nasal spray

Step 1

Prepare

  • Gently blow your nose to clear your nostrils.
  • Remove one device from the carton. Check the expiration date on the back of the blister package.
  • Peel off the paper backing completely. Flip the blister package onto your hand to remove the device from its packaging. Check the expiration date on the device.
Illustration showing how to hold Tosymra nasal spray upright, insert nozzle into nostril angled outward, and tilt head back slightly

Step 2

Administer the medication

  • Gently close 1 nostril with your finger and keep it shut.
  • Hold the device upright between your thumb and first 2 fingers. Insert half of the spray nozzle into the open nostril and angle outward.
  • While keeping the device in your nose, tilt your head back slightly to ensure the medicine doesn’t drip out.
  • As you slowly breathe in through your nose, press the plunger firmly all the way up to release the dose.
Illustration of person breathing gently through nose and out through mouth for 10 to 20 seconds after using Tosymra

Step 3

Remove and breathe

  • Remove the device from your nostril. Keep your head upright and do not look down because the medicine may drip from your nose. Do not breathe in deeply.
  • Gently breathe in through your nose and out through your mouth for 10 to 20 seconds.
Illustration of used Tosymra nasal spray device being disposed of in household trash

Step 4

Dispose

  • Throw away the used device and its packaging into your household trash.

Learn about Zembrace® SymTouch®, an injection just below the skin

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INDICATION

What are ZEMBRACE® SymTouch® (sumatriptan succinate) injection and TOSYMRA® (sumatriptan) nasal spray?

ZEMBRACE SymTouch and TOSYMRA are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. ZEMBRACE SymTouch and TOSYMRA are not used to prevent or decrease the number of migraine headaches you have or for the treatment of hemiplegic or basilar migraines. ZEMBRACE SymTouch and TOSYMRA are not indicated as treatments for cluster headache or for use in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZEMBRACE SymTouch and TOSYMRA?

ZEMBRACE SymTouch and TOSYMRA can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a 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

ZEMBRACE SymTouch and TOSYMRA are 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 ZEMBRACE SymTouch or 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
  • hemiplegic 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 blood circulation
  • severe liver problems
  • an allergy to sumatriptan or any of the ingredients of ZEMBRACE SymTouch or TOSYMRA
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare 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 healthcare provider for a list of these medicines if you are not sure

Before taking ZEMBRACE SymTouch or TOSYMRA, tell your healthcare provider about all your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or a family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements. Especially tell your healthcare provider if you take antidepressant medicines called: selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), or monoamine oxidase inhibitors (MAOIs).

ZEMBRACE SymTouch and 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.

ZEMBRACE SymTouch and TOSYMRA may cause serious side effects including:

  • Raynaud's syndrome: changes in color or sensation in your fingers and toes
  • stomach and intestinal problems: symptoms include sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, and fever
  • problems with blood circulation to your legs and feet: symptoms include cramping and pain in your legs or hips; a 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
  • hives (itchy bumps): swelling of your tongue, mouth, or throat
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your healthcare provider
  • serotonin syndrome: a rare but serious problem that can happen in people using ZEMBRACE SymTouch or TOSYMRA, especially when used with antidepressant medicines called SSRIs or SNRIs. Call your healthcare 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
  • increased blood pressure: significant increases have been reported, including in people with no history of high blood pressure
  • seizures have happened in people who have never had seizures before

The most common side effects of ZEMBRACE SymTouch and TOSYMRA include pain and redness at injection site (ZEMBRACE SymTouch only), tingling or numbness, dizziness, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, application site (nasal) reactions (TOSYMRA only), abnormal taste and throat irritation (TOSYMRA only).

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

This is the most important information to know about ZEMBRACE SymTouch and TOSYMRA, but it is not comprehensive. For more information, talk to your healthcare provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call Tonix Medicines, Inc. at 1‑888‑869‑7633.

Please see additional safety information in the full Prescribing Information for ZEMBRACE SymTouch and TOSYMRA.

Call your healthcare provider for medical advice about side effects. You may report side effects to Tonix Medicines, Inc. at 1‑888‑869‑7633 or to the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch.

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