Tosymra

Tosymra is a prescription medication used to treat migraines with or without aura in adults. Tosymra belongs to a group of drugs called serotonin receptor agonist medications, which help constrict blood vessels in the brain.

This medication comes as a nasal spray and is given as a single spray in one nostril. Tosymra can be given up to three times in one day, with doses separated by at least one hour.

Common side effects include nasal irritation, loss of taste sensation, and throat irritation. Tosymra can cause dizziness, weakness, or drowsiness. Do not drive a car or operate heavy machinery until you know how Tosymra affects you.

Tosymra is a prescription medication used to treat migraines in adults, including migraines with or without aura. 

Tosymra is not for cluster headaches and cannot be used to prevent migraines.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tosymra. See the “Tosymra Precautions” section.

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
• throat irritation

This is not a complete list of Tosymra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ergot-containing drugs
  • ergotamine (Ergomar)
  • dihydroergotamine (Migranal)
• monoamine oxidase-A inhibitors
  • rasagiline (Azilect)
  • selegiline (Eldepryl, Zelapar)
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
• other serotonin agonists
  • tricyclic antidepressants like amitriptyline (Elavil) or notrtiptyline (Pamelor)
  • anti-migraine medication like triptans (sumatriptan, rizatriptan)
  • lithium
  • anti-nausea medication like metoclopramide (Reglan) or ondansetron (Zofran)
  • linezolid (Zyvox)
  • ritonavir (Norvir)
• antidepressants like selective serotonine reuptake inhibitors
  • citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine, paroxetine (Paxil) and sertraline (Zoloft)
• antidepressants like serotonin norepinephrine reuptake inhibitors
  • trazodone, duloxetine (Cymbalta), venlafaxine (Effexor)

This is not a complete list of Tosymra drug interactions. Ask your doctor or pharmacist for more information.

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.

Tosymra may cause other 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.

Do not take Tosymra if you:

• are allergic to Tosymra or to any of its ingredients

• have a history of ischemic coronary artery disease, history of heart attack, angina, or Prinzmetal's angina

• Wolff-Parkinson-White ysndrome or heart rhythm problems

• history of stroke or transient ischemic attack

• peripheral vascular disease

• ischemic bowel disease

• uncontrolled blood pressure

• recent use (24 hours) of an ergotamine-containing medication, ergot medication, or serotonin agonist

• currently use an MAOI

• severe liver dysfunction

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tosymra, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tosymra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tosymra or to any of its ingredients
• have high blood pressure, high cholesterol, or diabetes
• smoke
• are overweight
• have heart problems or family history of heart problems or stroke
• have kidney or 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 doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given products similar to Tosymra, and some babies had problems. Some babies died when injected with the medication. But in human studies, pregnant women were given this medication and their babies did not have any problems related to this medication.

Some studies show that women with migraines may have higher blood pressure and present signs of pre-eclampsia during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Tosymra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tosymra.

Take Tosymra exactly as prescribed.

• See the "Instructions for Use" that is supplied with your medication for complete information on how to use Tosymra nasal spray.
• Certain people should take their first dose of Tosymra in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
• Use Tosymra exactly as your healthcare provider tells you to use it.
• You should take Tosymra as soon as the symptoms of your headache start, but it may be taken at any time during a migraine.
• If your headache comes back after the first nasal spray or you only get some relief from your headache, you can use a second nasal spray 1 hour after the first nasal spray.
• Do not use more than 30 mg of Tosymra Nasal Spray in a 24‐hour period.
• If you use too much Tosymra, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take Tosymra, so you can talk with your healthcare provider about how Tosymra is working for you.

How to administer Tosymra:

While sitting upright, gently blow the nose.

Press 1 nostril with a finger to keep it closed.

Deliver 1 dose of Tosymra with one spray:

• By holding the device upright
• Inserting half of the spray nozzle into the open nostril
• Angling the device nozzle slightly outward and tilting head slightly backward
• Slowly breathing in and pressing the plunger up to release the spray

Once administration is complete gently breathe in through the nose and out through the mouth for 10 to 20 seconds.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose/dose range of Tosymra (sumatriptan) is one spray (10mg) in one nostril. 

Maximum dose in a 24‐hour period is 30 mg (3 sprays). Separate doses by at least one hour.

If you take too much Tosymra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store between 68° to 77°F (20° to 25°C)
• Do not store in the refrigerator or freeze.
• Do not test before use.

Keep Tosymra and all medicines out of the reach of children.