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IF YOUR migraine IS HERE, WHY ONLY SEND treatment HERE? What is ONZETRA™ Xsail™ (sumatriptan nasal powder) used for? ONZETRA Xsail is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache. For additional Important Safety Information, please see full Prescribing Information, including Patient Information and Instructions for Use, in the pocket and pages 12-13 of this brochure. Send medication directly to the back of the nose with a new Breath Powered ® delivery system Learn why the nose matters

IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

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Page 1: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

IF YOUR migraine IS HERE,

WHYONLY SEND

treatment HERE?

What is ONZETRA™ Xsail™ (sumatriptan nasal powder) used for? ONZETRA Xsail is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

For additional Important Safety Information, please see full Prescribing Information, including Patient Information and Instructions for Use, in the pocket and pages 12-13 of this brochure.

Send medication directly to the back of the nose with a new Breath Powered® delivery systemLearn why the nose matters

Page 2: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

BLOWExhaling forcefully propels the sumatriptan powder deep into the back of your nose

CLOSEBlowing into the device closes the flap separating the back of the nose from the throat, which may help limit the amount of medication reaching the stomach or lungs

DELIVERONZETRA targets an area deep in the back of your nose with the potential for fast absorption

WIDENThe specially designed nosepiece helps to gently widen the nasal valve, allowing the medication to start its route to the back of the nose

Breath Powered® delivery: How it works is why it works differentlyONZETRA Xsail is different than anything you’ve used before. It is not a liquid nasal spray or an inhaler. It’s a Breath Powered® nasal delivery system for the treatment of migraines.

ONZETRA is taken with a small, innovative device called Xsail. It uses your own breath to deliver medication deep into the back of your nose.

Research suggests that the back of the nose is rich in blood vessels and absorbent tissue, which may help deliver medication into the bloodstream.

Important Safety InformationONZETRA Xsail is indicated for the acute treatment of migraine attacks, with or without aura in adults. Only your doctor can determine if ONZETRA Xsail is right for you. ONZETRA Xsail is not for the prevention of migraines or for the treatment of other types of headaches. Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you have heart problems, a history of heart problems, have had a stroke, have problems with your blood circulation, or have uncontrolled high blood pressure.

For additional Important Safety Information about ONZETRA Xsail, please see pages 12-13.

Learn how to use ONZETRA Xsail on page 6. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

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• Migraine is a neurological disorder. During an attack, your nerves release inflammatory substances that cause your blood vessels to expand. This causes painful throbbing

• In addition to pain, some people also have to deal with migraine-related nausea, vomiting, or sensitivity to light and sound

- Taking something different than pills may be an option for people with nausea or vomiting

When talking to your doctor about ONZETRATM XsailTM, remember to discuss all symptoms and medical conditions.

Common treatment for migrainesThere are several medications for migraines. The most widely prescribed medication is sumatriptan. In general, it has been used safely and effectively for over 20 years.

Unlike most other sumatriptan options, ONZETRA Xsail takes a different routeONZETRA is a rapidly absorbed sumatriptan powder delivered to the back of the nose.

ABOUT MIGRAINES AND SUMATRIPTAN

Page 3: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

Within 48 hours of the initial dose, 63% of people who used ONZETRA did not take another dose or additional medication (vs 48% on placebo)*

ONZETRATM XsailTM provides FAST relief that may LAST with one dose

Almost half of migraine sufferers experienced pain relief in 30 minutes(42% vs 27% on placebo)

Twice as many people were pain free at 2 hours versus people not taking ONZETRA(34% vs 17% on placebo)

IF RELIEF CAN BE quick,WILL IT ALSO stick?

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*Patients were not asked why they did not take another dose or additional medication.

Important Safety InformationONZETRA Xsail may cause serious side effects and should not be used by certain patients, including those with a history of heart problems or who have had a stroke. These are not all the risks of use of ONZETRA Xsail.

For additional Important Safety Information about ONZETRA Xsail, please see pages 12-13.

30 minutes

2hours

48hours

What are the side effects?In the clinical studies, sensations typically associated with triptans (ie, chest pressure and tightness) were reported in less than 2% of attacks treated with ONZETRA. None of these events were serious or led people to discontinue ONZETRA. These sensations commonly occur after treatment with triptans and are usually non-cardiac in origin. However, if you have heart problems or a history of heart problems be sure to tell your doctor before using ONZETRA.

Safety AND tolerability OF ONZETRA XSAIL

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The most common side effects reported by people using ONZETRA were:

• A mild metallic taste

• Nasal discomfort

• Runny nose and stuffy nose

These are not all the possible risks of ONZETRA. Tell your doctor about any side effect that bothers you or does not go away. For additional Important Safety Information about ONZETRA Xsail, please see the full Prescribing Information, including Patient Information and Instructions for Use, in the pocket.

Page 4: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

These are not the complete Instructions for Use. Prior to using ONZETRA Xsail, carefully review the full Instructions for Use in the Prescribing Information. You can also watch them online at onzetra.com or by texting ONZETRA to 313131.

BLOW FORCEFULLYBlow into the device for 2-3 seconds. Throw away the first nosepiece in the trash.

REPEAT STEPS 1-3 with the second nosepiece in the opposite nostril.

3

Position the device by inserting the nosepiece deeply into your nose. Keep the nosepiece in your nose while you rotate the device to place the mouthpiece into your mouth.

POSITION IN NOSE AND MOUTH2

READY MEDICATIONInsert the first nosepiece into the device. Fully PRESS and RELEASE the white button to pierce the medication capsule. If you skip this step, you will not get any medication.

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NEARLY 90% OF PATIENTS FOUND ONZETRATM XSAILTM easy to use

Everything you need

in one place.OnTrack Support is a helpful program of support and information for ONZETRA Xsail.

Find all this support at onzetra.com

• Co-Pay Savings Card: $0 co-pay on your first prescription*

• Questions about insurance coverage• Co-pay calculator• Financial assistance • Free home delivery• Helpful nurse hotline

Looking for Financial Assistance? Or even a way to get ONZETRA Xsail delivered to your home? As a member of OnTrack Support, you have access to it all. Just call 1-844-ONZETRA (1-844-669-3872) to learn about everything below and more!

Access

It’s all about staying connected with up-to-date ONZETRA news and info. Get the resources you need to help stay on track once you start treatment.

• Exciting ONZETRA news• Helpful tips and advice

Connect

*Restrictions apply. Must have private insurance. Those eligible for Medicare, Medicaid, or any other government healthcare program are not eligible for this program. Card must be activated to receive $0 co-pay. Maximum benefit of $100 per prescription regardless of the co-pay amount.

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Page 5: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

These are folks who may be cycling through various medications, waking up with migraines, or often experiencing nausea or vomiting during an attack. Most importantly, they may be looking for an option that offers fast relief that may last. You might be, too.

ARE YOU A Migraineur?

Do you?• experience

migraines when you first wake up

• have migraines that progress quickly

• need fast pain relief that can last

Aura THE MORNING SUFFERER

LIKE:

Do you?• have nausea or

vomiting during migraines

• avoid taking medication during migraines

• feel you’re open to trying a different delivery of medication

Bolt THE EASILY QUEASY

LIKE:

Do you?• cycle through

multiple medications

• battle migraine recurrence

• often need to take additional medication

Raye THE MERRY- GO-ROUNDER

LIKE:

If you feel their pain,

ONZETRA™ Xsail™ may be right for you.Ask your doctor about ONZETRA.

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Page 6: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

Talk to your doctorABOUT YOUR MIGRAINES

FREQUENTLY ASKEDquestionsWhat kind of medication is ONZETRA?ONZETRA is a sumatriptan nasal powder that’s delivered through a Breath Powered® Xsail device. ONZETRA is not for the prevention of migraine, but rather, for the acute treatment of migraine.

How long will it take to experience relief?In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo.

When should I use ONZETRA?A full dose of ONZETRA is 22 mg. It should be taken when you first start to feel migraine symptoms. Do not overuse your medication. Some people who use migraine medications too many times may have worse headaches. Please talk to your doctor if your headaches get worse.

How will I know if I’m using ONZETRA correctly?When used correctly, the medication should be gone. Check the nosepiece to make sure the medication is not there. A little white residue inside the nosepiece chamber or capsule is normal. Proper use also means that you used both nosepieces—one in each nostril.

How often can I take ONZETRA to treat a migraine?If your migraine returns, or you only get some relief from your headache, you can take another full dose of ONZETRA two hours after your first full dose. The maximum recommended dose that may be given in 24 hours is two doses of ONZETRA.

To see more frequently asked questions, visit onzetra.com.

Be sure to tell your doctor if you:• Are not fully satisfied with your current treatment • Experience nausea or vomiting during a migraine• Want something different that also offers fast relief• Need an option with relief that can last

Ask your doctor about treatment options and ONZETRATM XsailTM

• What are the options besides oral medications to treat migraines?

• Is a nasal delivery option right for me?• What is ONZETRA?• Is ONZETRA right for me?

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Important Safety InformationONZETRA Xsail may cause serious side effects and should not be used by certain patients. Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you have heart problems, a history of heart problems, have had a stroke, have problems with your blood circulation, or have uncontrolled high blood pressure.

For additional Important Safety Information about ONZETRA Xsail, please see pages 12-13.

Page 7: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

P R E S C R I B I N G I N F O R M AT I O N

What is ONZETRA™ Xsail™ (sumatriptan nasal powder) used for?ONZETRA Xsail is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

What important information should I know about ONZETRA Xsail?

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

The most common side effects of ONZETRA Xsail are abnormal taste, discomfort of your nose or throat, runny nose, and stuffy nose. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Who should not take ONZETRA Xsail?

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

What should I tell my healthcare provider before taking ONZETRA Xsail?Before you take ONZETRA Xsail, tell your doctor about all your medical conditions and all the medicines you take, including prescription medicines, especially antidepressants, and all over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ONZETRA Xsail?ONZETRA Xsail 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.

For additional Important Safety Information about ONZETRA Xsail, please see the full Prescribing Information, including Patient Information and Instructions for Use, in pocket.

IMPORTANT SAFETY INFORMATION

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Page 8: IF YOUR migraine - ONZETRA€¦ · In a clinical study, over 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. When should I use ONZETRA? A full dose

© 2016 Avanir Pharmaceuticals, Inc. All rights reserved. ONZETRA, Xsail, and Avanir are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries. Breath Powered is a registered trademark of OptiNose AS. ONZ-0076-BRO-0316

Visit onzetra.com

I F ONZETRATM XSAILTM IS R IGHT FOR YOU

Ask your doctor

Fast PAIN RELIEFdelivered WITH ONE DOSE

Important Safety Information

ONZETRA Xsail is approved for the acute treatment of migraine, with or without aura in adults. Only your doctor can determine if ONZETRA is right for you. ONZETRA is not for the prevention of migraines or for the treatment of other types of headaches. ONZETRA Xsail may cause serious side effects and should not be used by certain patients, including those with a history of heart problems or who have had a stroke. These are not all the risks of use of ONZETRA Xsail.

For additional Important Safety Information about ONZETRA Xsail, please see pages 12-13.

• Send medication directly to the back of the nose with a new Breath Powered® delivery system

• Easy to use

• Savings and support to help keep you on track