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Call your doctor’s office or call our Medical Information group to speak with a healthcare professional at 1-866-ZOGENIX.

SUMAVEL DosePro is a prescription medicine administered with a needle-free delivery system to treat adults who have been diagnosed with migraine or cluster headaches. SUMAVEL DosePro is not used to prevent or lessen the number of migraine or cluster headache attacks you have. SUMAVEL DosePro is not used to treat other types of headaches.

a. The medication in SUMAVEL DosePro is called sumatriptan. It is thought to work at the serotonin receptors, which have an effect on the nerves and blood vessels in your head.

b. SUMAVEL DosePro is a needle-free delivery system used to deliver the drug under the skin. It does this by propelling the drug through the skin with a burst of air, which is activated when pressed against the skin. By delivering this medication subcutaneously (under the skin), it can be absorbed into the bloodstream quickly. In clinical studies, relief started within 10 minutes for some patients, with most achieving relief within 1 or 2 hours.

Patients experiencing migraines should use their medication as soon as they feel a migraine coming on, or as directed by your healthcare provider.

You may deliver a second dose of SUMAVEL DosePro or 1 dose of another sumatriptan medicine separated by at least 1 hour. Do not deliver more than 2 doses of SUMAVEL DosePro in a 24-hour period. The benefit of a second dose in patients who have failed to respond to a first dose has not been established.

Do not use within 24 hours of treatment with ergotamine-containing or ergot-type medications or other 5-HT₁ agonists (eg, triptans) with the exception of another sumatriptan medicine, separated by at least 1 hour. Please read the patient labeling to check for a list of medications that you should not take with SUMAVEL DosePro within 24 hours.

A small amount of bleeding may occur at the administration site. If it occurs, you can simply wipe it away. Although there was a higher incidence of initial bleeding in clinical studies with SUMAVEL DosePro compared to needle-based sumatriptan, all cases were considered to be minor and did not require medical intervention.

Some people may experience swelling, redness, bruising, or bleeding at the administration site. No patients stopped taking SUMAVEL DosePro in clinical studies for reasons related to these reactions.

Deliver SUMAVEL DosePro into your stomach area (abdomen), or thigh. Do not deliver SUMAVEL DosePro into the arm or other body parts; into a muscle or vein; within 2 inches of your belly button (navel); or into scars or moles. Read the detailed instructions for use in the patient labeling.

Needle free may not mean pain free—you may experience some discomfort upon administration. Expect to feel something like the snapping of a rubber band against your skin.

As soon as you press SUMAVEL DosePro firmly to your skin, you will hear the burst of air and the medicine will be delivered. This takes less than a second. You do not have to hold SUMAVEL DosePro against your skin after you hear the burst of air.

No. SUMAVEL DosePro is single use only and should be discarded after use.

No.

Store SUMAVEL DosePro between 59°F to 86°F (15°C to 30°C). Do not freeze.

No, you should not use it if it has been frozen or exposed to temperatures higher than 86°F (30°C) or lower than 59°F (15°C).

Yes, you can travel with SUMAVEL DosePro on an airplane; however, be prepared to provide proof of prescription, such as the product label, your pharmacy receipt and/or the patient instruction sheet included in each individual box. For the most current information regarding carry-on restrictions, contact the Transportation Security Administration (1-866-289-9673 or visit www.tsa.gov), your airline, or your airport since regulations often change.

You should not use SUMAVEL DosePro if the tip has broken off. The tip protects the sterile application surface. It should only be removed when you are ready to take your dose.

It is normal for there to be small bubbles in the clear drug chamber, and their presence will not affect your dose. However, if the glass chamber is only partially filled, call 1-866-ZOGENIX to report the problem and get instructions on how to return SUMAVEL DosePro and obtain a replacement.

The medication is clear and colorless to pale yellow, making the drug chamber appear empty.

You can tell if SUMAVEL DosePro has been discharged if you see the "piston" filling the clear chamber. If you are only able to see the pointed end of the white piston in the drug chamber, it has not been discharged.

In very rare cases, people taking triptans, such as SUMAVEL DosePro, may experience serious side effects, including heart attacks. Call your doctor right away if you have:

• severe chest pain
• shortness of breath

The most common side effects of SUMAVEL DosePro include:

• bleeding, swelling, redness, bruising, and pain at the administration site
• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• feeling of heaviness or pressure
• discomfort or tightness in the chest, neck, throat, nose, or jaw

Tell your doctor about your medical condition(s) and history as well as the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Please read the Important Safety Information below.