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How to use SUMAVEL DosePro

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SUMAVEL DosePro is designed to be used in just 3 simple steps:

Step 1: SNAP the tip off
Step 2: FLIP the green lever down to get it ready
Step 3: PRESS against your skin to deliver the medicine

WHAT TO EXPECT WHEN YOU USE SUMAVEL DosePro

SOUND

When you break the tip, it may feel and sound like the snapping of a carrot. There is a sound when you deliver the medicine that is similar to the opening of a soda can.

SITE SENSATION

Needle free doesn't mean you won't feel anything. Expect to feel something like the snapping of a rubber band against your skin.

SITE REACTIONS

You may experience some bleeding, swelling, redness, or bruising at the delivery site. In clinical trials, no one stopped using SUMAVEL DosePro because of side effects.

Checking SUMAVEL DosePro before you start

Here's a quick look at the simple steps involved with SUMAVEL DosePro. This is not intended to take the place of the complete Patient Instructions For Use, which can be found on the last page of the patient labeling information. Before using SUMAVEL DosePro for the first time, make sure your healthcare provider shows you the correct way to use it.

Check the tip:

Make sure the snap-off tip is firmly attached. Don’t use it if it’s already snapped off or tilted.

Check the medication chamber:

The medicine inside should be colorless or pale yellow. Don’t use it if it’s dark or cloudy.

Check the expiration date:

It's printed on both the SUMAVEL DosePro label and the carton. Do not use SUMAVEL DosePro if the medicine is expired.

Prepare delivery site:

  • You can choose either your stomach or thigh (SUMAVEL DosePro should not be used on your arm or other body parts)
  • Make sure the delivery site is clean, dry, and free of clothing. Do not inject into scars or moles or within 2 inches of the belly button. Do not use it at the same administration site every time

Simply pinch skin and press firmly and in less than a second, your medicine is delivered. Some people may have a very small amount of blood at the delivery site. If so, simply wipe it away. Read the patient information that comes with SUMAVEL DosePro before use.

For additional information, ask your doctor about SUMAVEL DosePro or call 1-866-ZOGENIX to speak with a healthcare professional.

 

 

INDICATION

SUMAVEL DosePro is a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches.

IMPORTANT SAFETY INFORMATION

• SUMAVEL DosePro is not used to treat other types of headaches or to prevent or lessen the number of migraine or cluster headache attacks you have.

 

• Do not take SUMAVEL DosePro if you have heart disease or a history of heart disease, narrowing of blood vessels to the legs, arms, stomach or kidney, uncontrolled high blood pressure, migraines that cause temporary paralysis on one side of your body or basilar migraine, had a stroke, transient ischemic attacks or problems with your blood circulation, have taken another triptan or ergotamine medicine in the last 24 hours, or are allergic to sumatriptan.

 

• Tell your doctor if you have heart disease or a family history of heart disease or stroke, high cholesterol, diabetes, have gone through menopause, are a smoker, have had epilepsy or seizures, or if you are pregnant, nursing, or could become pregnant before taking SUMAVEL DosePro. Especially tell your doctor if you take antidepressant medicines called SSRIs, SNRIs or MAO Inhibitors. A life-threatening problem called serotonin syndrome may occur with SUMAVEL DosePro, especially if used with antidepressants.

 

• SUMAVEL DosePro can cause serious side effects, including death. Possible side effects include heart attack, fast heartbeat, increase in blood pressure, stroke, changes in mental status such as agitation, hallucinations or coma, tight muscles or trouble walking, changes in color or sensation in fingers or toes, or decreased blood flow to the extremities or intestines.

 

• Get medical help right away if you have severe tightness, pain, pressure or heaviness in your chest, throat, neck or jaw, shortness of breath or wheezing, sudden or severe stomach pain, hives, swelling of your tongue, mouth or throat, high temperature, trouble seeing, unusual weakness or numbness, nausea, vomiting or diarrhea, or unusual sweating.

 

• Tell your doctor about all medications you take including prescription and nonprescription medicines, vitamins and herbal supplements.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The information in this section is intended for healthcare professionals in the United States and is not intended for the general public.

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