Indication and Important Safety Information for TOSYMRA® (sumatriptan) nasal spray


Indication

What is TOSYMRA® (sumatriptan) nasal spray?

TOSYMRA® (sumatriptan) nasal spray is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. TOSYMRA is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. TOSYMRA is not indicated as a treatment 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 TOSYMRA?

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

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:

  • 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 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
  • 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 provider for a list of these medicines if you are not sure
  • an allergy to sumatriptan or any of the ingredients of TOSYMRA

Before taking 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 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 anti-depressant medicines called: selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), or monoamine oxidase inhibitors (MAOIs).

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.

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, fever
  • problems with blood circulation to your legs and feet: symptoms 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 one or both legs or feet
  • 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 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
  • increased blood pressure: significant increases have been reported, including in people with no history of high blood pressure
  • hives (itchy bumps): swelling of your tongue, mouth, or throat
  • seizures: have happened in people who have never had seizures before

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

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 TOSYMRA. For more information, ask your healthcare provider.

This is the most important information to know about 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.

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.