Onzetra Xsail

Onzetra Xsail is a prescription medication used to treat migraine headaches once they have started, with or without aura.

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

Onzetra Xsail may cause serious side effects, including:

• Heart attack and other heart problems, which may lead to death. Stop using Onzetra Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
• Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
• Stomach and intestinal problems (gastrointestinal and colonic ischemic events)
• Problems with blood circulation to your legs and feet (peripheral vascular ischemia)
• Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
• Medication overuse headaches. Some people who use Onzetra Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with Onzetra Xsail
• Serotonin syndrome, a rare but serious problem that can happen in people using Onzetra Xsail, especially if Onzetra Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor 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; trouble walking; or nausea, vomiting, or diarrhea
• Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before

Do not take Onzetra Xsail or stop using Onzetra Xsail if you:

• Have heart problems or a history of heart problems
• Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• Have uncontrolled high blood pressure
• Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor
• Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)
• Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications. Ask your doctor for a list of these medicines if you are not sure
• Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking Onzetra Xsail
• Have severe liver problems
• Have an allergy to sumatriptan, the medicine in Onzetra Xsail, or any of the components in Onzetra Xsail

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

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you have taken more Onzetra Xsail than has been prescribed for you, contact either your doctor, hospital emergency department, or your local Poison Control Center.

In the U.S.

• Imitrex
• Onzetra Xsail

Available Dosage Forms:

• Powder
• Spray

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Onzetra Xsail. Please read with care.

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 in 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 as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment.

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 2 hours after the first dose. Do not use more than 3 doses in any 24-hour period.

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

To use the nasal powder:

• This medicine is given through 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.

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:
    • 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.

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.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use this medicine if you have taken other triptan or ergot-type migraine medicines within 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 (eg, Nardil®, Parnate®) in the past 14 days.

This medicine may cause serious type of allergic reaction called anaphylaxis. Anaphylaxis 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 color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

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

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

This medicine may increase your risk of having abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to occur 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 right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an 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 in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record the headache frequency and drug use.

Make sure your doctor knows about all the other medicines you are using. 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 blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor).

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel dizzy or drowsy during or after a migraine, or using sumatriptan to relieve a migraine. As long as you are feeling dizzy or drowsy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

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

• If you have an allergy to sumatriptan succinate or any other part of ONZETRA Xsail (sumatriptan nasal powder).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
• If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke; or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
• If you have liver disease.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking another drug that has the same drug in it.
• If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan in the last 24 hours.
• If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with ONZETRA Xsail.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take ONZETRA Xsail. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• High blood pressure has happened with ONZETRA Xsail. Have your blood pressure checked as you have been told by your doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• This medicine is not meant to prevent or lower the number of migraine headaches you get. Talk with your doctor.
• If you have a headache that is not like your usual migraine headaches, talk with your doctor before you take this medicine.
• Taking more of ONZETRA Xsail (a higher dose, more often) than your doctor told you to take may cause your headaches to become worse.
• Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
• Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this medicine. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
• Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with ONZETRA Xsail. Call your doctor right away if you have a change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ONZETRA Xsail while you are pregnant.

• Store at room temperature. Do not refrigerate or freeze.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.