Sumatriptan Succinate, Intranasal Powder

________________________________________________________________________

KEY POINTS

• This medicine is given by breathing into a device that delivers medicine into your nose to treat migraine headaches. It will not prevent migraine headaches or reduce the number you may have. Use it exactly as directed.
• This medicine may cause serious heart problems, stroke, increased blood pressure, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: 5-HT1B/1D receptor agonist; antimigraine

Generic and brand names: sumatriptan succinate, intranasal; Onzetra Xsail

What is this medicine used for?

This medicine is given by breathing into a device that delivers medicine into your nose to relieve the pain of acute migraine headaches in adults. It will not prevent migraine headaches or reduce the number you may have. This medicine is not intended to treat other types of headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A heart attack, heart disease, angina, or blood vessel disease
• A stroke or transient ischemic attack (TIA)
• Cluster headaches
• Hemiplegic or basilar migraine
• High blood pressure
• Liver or kidney problems
• Peripheral vascular disease or Raynaud syndrome (problems with blood circulation)
• Seizures

Talk with your healthcare provider if you have any risk factors for heart disease such as diabetes, high cholesterol, smoking, being overweight, past menopause, or if you have a family history of heart disease or stroke.

Do not take an MAO inhibitor within 14 days before you start or 14 days after you stop taking this medicine. Do not take this medicine if you have taken cabergoline, or if you have taken any other migraine medicine in the past 24 hours.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is supplied as a disposable nosepiece with the medicine inside, and a reusable breath-powered device. You blow with your mouth into the device to deliver medicine into your nose. Each disposable nosepiece contains half a dose of medicine (11 mg of sumatriptan), one for each nostril. A full dose is 22 mg. Do not use more than 2 nosepieces per dose.

If your headache is not better, you may use a second dose after at least 2 hours if your healthcare provider approves. Do NOT use more than 44 mg (2 doses) of this medicine in a 24-hour period. If you use migraine medicines too often, you may have worse headaches. Talk with your healthcare provider about this.

Ask your healthcare provider or pharmacist about anything you do not understand.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: tremors, skin redness, trouble breathing, slow breathing, blue-colored lips or fingernails, large pupils, weakness, lack of coordination, being unable to move, seizures.

What should I watch out for?

This medicine may cause life-threatening heart problems, heart attack, stroke, or increased blood pressure. Contact your healthcare provider right away if you have:

• Chest pain or pressure, squeezing, or fullness in the center of your chest that lasts more than a few minutes, or goes away and comes back (may feel like indigestion or heartburn)
• Pain or discomfort in one or both arms or shoulders, or in your back, neck, jaw, or stomach
• Trouble breathing
• Breaking out in a cold sweat for no known reason

Along with these symptoms, you may also feel very tired, faint, or sick to your stomach.

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination or trouble walking
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea and vomiting
• Stiff muscles
• Diarrhea

You should not use this medicine for more than 10 days per month. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches. Tell your healthcare provider if you need to use the medicine more often, if the medicine is not working as well, if you have headaches more often, or if your headaches get worse. If you have more than 4 migraine attacks a month, ask your healthcare provider what to do.

This medicine may make you weak, dizzy, or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; seizures.

Serious (Report these to your healthcare provider right away.): Jaw or neck tightness, chest pain, irregular or rapid heartbeat, sudden or severe stomach pain; trouble breathing; bloody or severe diarrhea; severe constipation; hallucinations; severe nausea or vomiting; unexplained fever; unusual sweating; severe nervousness; pale or blue-colored hands or feet; pain, numbness, or tingling in legs, hands or feet; unusual muscle stiffness; vision changes.

Other: Mild nausea or diarrhea, mild dizziness, drowsiness, change in sense of taste, runny or stuffy nose, mild throat or nose irritation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), levomilnacipran (Fetzima), nefazodone, nortriptyline (Pamelor), protriptyline (Vivactil), sertraline (Zoloft), trimipramine (Surmontil), and venlafaxine (Effexor)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), loxapine (Loxitane), olanzapine (Zyprexa), perphenazine, pimozide (Orap), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Buspirone
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), ergotamine/caffeine (Cafergot, Migergot), and methylergonovine (Do not take these within 24 hours of a dose of this medicine)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Metoclopramide (Metozolv, Reglan)
• Milnacipran (Savella)
• Natural remedies such as kava, SAMe, St. John's wort, and tryptophan
• Nausea medicines such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), palonosetron (Aloxi), and promethazine
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), sumatriptan/naproxen (Treximet), and zolmitriptan (Zomig), and inhaled migraine medicines (Do not take these within 24 hours of a dose of this medicine.)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), meperidine (Demerol), methadone (Dolophine, Methadose), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Rasagiline (Azilect)
• Tedizolid (Sivextro)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Do NOT store in the refrigerator or freezer. Keep the medicine in its original containers. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.