Onzetra Xsail (Nasal)

Sumatriptan nasal powder and spray are used to treat acute migraine headaches with or without aura in adults. It is not used to prevent migraine headaches and is not used to treat cluster headaches. Sumatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Many people find that their headaches go away completely after they use sumatriptan. Other people find that their headaches are much less painful, and that they can return to their normal activities even if their headaches are not completely gone. Sumatriptan often helps with other symptoms that happen with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially those who have heart or blood vessel disease. Be sure to discuss with your doctor the risks as well as the benefits of using this medicine.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep using it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you have taken other triptan or ergot-type migraine medicines in the past 24 hours. Some examples of triptan medicines are almotriptan (Axert®), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®), sumatriptan/naproxen (Treximet®), or zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, Wigraine®), or methysergide (Sansert®). Also, do not use this medicine if you have taken a MAO-A inhibitor (e.g., Nardil®, Parnate®) in the past 14 days.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in facial skin color, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these side effects happen, get emergency help right away.

Check with your doctor if you have used this medicine and your migraine got worse or started happening more often.

This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, they may want you to take your first dose in the doctor’s office or clinic.

This medicine may increase your risk of having an abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to happen if you or a family member already has heart disease, if you have diabetes, high blood pressure, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, shortness of breath, or sweating. Call your doctor immediately if you have any symptoms of a stroke, such as confusion, difficulty speaking, double vision, headaches, inability to move the arms, legs, or facial muscles, inability to speak, or slow speech.

Check with your doctor right away if you have chest discomfort, jaw, or neck tightness after using this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain or bloody diarrhea after using this medicine.

Using sumatriptan alone or with other migraine medicines for 10 or more days each month may lead to worsening headaches. You may keep a headache diary to record how often you have headaches and your medicine use.

Make sure your doctor knows about all the other medicines you are taking. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.

Check with your doctor immediately if you have blurred vision, difficulty reading, or any other change in vision during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor).

Drinking alcohol can make headaches worse or cause new headaches to occur. People who have severe headaches should probably avoid alcohol, especially during a headache.

Some people feel dizzy or drowsy during or after a migraine, or when using sumatriptan to relieve a migraine. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of sumatriptan nasal powder and spray in children. The use of Tosymra™ is not recommended in children as safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems related to age that would limit the use of Tosymra™ in older adults. However, older patients are more likely to have liver, kidney, or heart issues due to age, which may require careful monitoring and dose adjustments for those using this medicine.

The use of Imitrex® and Onzetra™ is not recommended in older patients with kidney issues, heart or blood vessel disease, or high blood pressure, and should not be used by older patients with liver problems.

Breast Feeding

There are no adequate studies to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could occur. In these cases, your doctor might adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The interactions listed here are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose to not prescribe this medication or adjust your other medicines.

• Almotriptan
• Bromocriptine
• Dihydroergotamine
• Eletriptan
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Frovatriptan
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Methylergonovine
• Methysergide
• Moclobemide
• Naratriptan
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Rizatriptan
• Safinamide
• Selegiline
• Tranylcypromine
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Buprenorphine
• Bupropion
• Butorphanol
• Citalopram
• Clomipramine
• Codeine
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Dolasetron
• Doxepin
• Duloxetine
• Escitalopram
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Imipramine
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Metaxalone
• Methamphetamine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Nortriptyline
• Ondansetron
• Opipramol
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentazocine
• Protriptyline
• Reboxetine
• Remifentanil
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Tapentadol
• Tianeptine
• Tramadol
• Trazodone
• Trimipramine
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods, as interactions may occur. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Angina (chest pain) or
• Arrhythmia (heart rhythm problem) or
• Basilar migraine (migraine with vision and hearing problems), history of or
• Heart attack, history of or
• Heart or blood vessel problems or
• Hemiplegic migraine (migraine with some paralysis), history of or
• Hypertension (high blood pressure), uncontrolled or
• Ischemic bowel disease (bowels have low blood supply) or
• Liver disease, severe or
• Peripheral vascular disease (clogged arteries) or
• Stroke, history of or
• Transient ischemic attack (TIA), history of or
• Wolff-Parkinson-White Syndrome (heart rhythm problem)—Should not be used in patients with these conditions.

• Bleeding problems or
• CNS disorders or
• Eye or vision problems or
• Kidney disease or
• Liver disease or
• Seizures or epilepsy, history of or
• Stomach or bowel bleeding—Use with caution. May worsen these conditions.

• Coronary artery disease, family history of or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure), controlled or
• Obesity or
• Raynaud's syndrome—Use with caution. May increase the risk for certain side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Chest pain (mild)
• Difficulty with swallowing
• Heaviness, tightness, or pressure in the chest or neck
• Pounding heartbeat
• Skin rash, hives, itching, or bumps on the skin

Rare

• Changes in skin color of the face
• Chest pain (severe)
• Fast or irregular breathing
• Puffiness or swelling of the eyelids, area around the eyes, face, or lips
• Seizures
• Troubled breathing

Incidence not known

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast, irregular, pounding, or racing heartbeat or pulse
• Inability to move the eyes
• Increased blinking or spasms of the eyelid
• Sticking out of the tongue
• Sweating
• Tremor
• Trouble in speaking
• Uncontrolled twisting movements of the neck, trunk, arms, or legs
• Unusual facial expressions
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, discharge, pain, or soreness in the nose
• Change in taste
• Discomfort in the jaw, mouth, tongue, throat, nose, or sinuses
• Dizziness
• Drowsiness
• Feeling cold, “strange,” or weak
• Feeling of burning, warmth, heat, numbness, tightness, or tingling
• Flushing
• Lightheadedness
• Muscle aches, cramps, or stiffness
• Nausea
• Redness of the face, neck, arms, and occasionally, upper chest
• Unusual or unpleasant (after) taste
• Vomiting

Less common

• Feeling of constant movement of self or surroundings
• Sensation of spinning

Less common or rare

• Anxiety
• Burning sensation
• Discomfort of the nasal cavity and throat
• General feeling of illness or tiredness
• Vision changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Imitrex
• Onzetra Xsail
• Tosymra

Available Dosage Forms:

• Powder
• Spray

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Using too much sumatriptan may increase the chance of side effects.

This medicine is for use only in the nose. Do not get any of it into your eyes or on your skin. If it does get on these areas, rinse it off right away.

Do not use this medicine for a headache that is different from your usual migraines. Instead, check with your doctor.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan.

Ask your doctor ahead of time about any other medicine you might take if sumatriptan does not work. After you take the other medicine, check with your doctor right away. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatments.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, you may use one additional dose of sumatriptan at least 1 hour (Tosymra™) or 2 hours (Imitrex® or Onzetra™) after the first dose. Do not use more than 3 doses in any 24-hour period.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use the nasal powder:

• This medicine is given through the Xsail™ breath-powered delivery device.
• Remove the disposable nosepiece from its foil pouch, then remove the clear device cap from the reusable delivery device, and click the nosepiece into the device body. Use the nosepiece immediately after removing from the foil pouch.
• Fully press and release the white piercing button on the device body to pierce the capsule inside the nosepiece. Press it only once.
• Insert the nosepiece into the nostril so that it makes a tight seal. The device is then rotated and the mouthpiece inserted between the lips.
• Blow forcefully through the mouthpiece to deliver the medicine into the nasal cavity. Do not press the white button while blowing.
• Press the clear tab to remove the first nosepiece. Throw the used nosepiece in the trash can.
• Repeat the same steps using a second nosepiece into the other nostril to complete the recommended dose.

To use the nasal spray:

• Gently blow your nose to clear the nostrils before you use this medicine.
• Gently press one nostril to close it.
• Hold the device upright between your thumb and first 2 fingers. Insert half of the spray nozzle into the open nostril and angle outward.
• Tilt your head back slightly.
• Firmly press the plunger all the way up as you slowly breathe through your nose.
• Remove the device from your nostril. Keep your head upright and gently breathe in through your nose and breathe out through your mouth. Repeat this for 10 to 20 seconds. You may feel liquid in your nose or at the back of your throat.
• Do not look down as this may cause the medicine to drip from your nose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (nasal powder):For migraine headaches: Adults—22 milligrams (mg) (1 nosepiece in each nostril, total of 2 nosepieces) per day. Another dose (22 mg) may be used as long as it has been at least 2 hours since the last spray. Do not use more than 44 mg (4 nosepieces) in a 24-hour period (one day). Children—Use and dose must be determined by your doctor.
• For nasal dosage form (nasal solution):For migraine headaches: Imitrex®: Adults—5 milligrams (mg) (1 spray into one nostril) or 10 mg (2 sprays in one nostril or 1 spray in each nostril) or 20 mg (1 spray into one nostril). Another spray (5 mg, 10 mg, or 20 mg) may be used as long as it has been at least 2 hours since the last spray. Do not use more than 40 mg in a 24-hour period (one day). Children—Use and dose must be determined by your doctor. Tosymra™: Adults—10 mg given as 1 spray in one nostril. Another spray may be used as long as it has been at least 1 hour since the last spray. Do not use more than 30 mg in a 24-hour period (one day). Children—Use is not recommended.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not store in the refrigerator or freezer.

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