"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
(sumatriptan injection) Needle-free Delivery System
Read this Patient Information before you start using Sumavel DosePro and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Sumavel DosePro?
Sumavel DosePro can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking Sumavel DosePro and get emergency medical help right away if you have any of the following symptoms of a heart attack:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
Sumavel DosePro is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
- have high blood pressure
- have high cholesterol levels
- are overweight
- have diabetes
- have a family history of heart disease
What is Sumavel DosePro?
Sumavel DosePro is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.
Sumavel DosePro is not used to prevent or decrease the number of migraine or cluster headaches you have.
It is not known if Sumavel DosePro is safe and effective in children under 18 years of age.
Who should not take Sumavel DosePro?
Do not take Sumavel DosePro if you have:
- heart problems or a history of heart problems
- narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
- had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
- taken any of the following medicines in the last 24
- almotriptan (AXERT®)
- eletriptan (RELPAX®)
- frovatriptan (FROVA®)
- naratriptan (AMERGE®)
- rizatriptan (MAXALT®, MAXALT-MLT®)
- ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
- dihydroergotamine (D.H.E. 45®, MIGRANAL®)
Ask your healthcare provider if you are not sure if your medicine is listed above.
- are allergic to sumatriptan or any of the ingredients in Sumavel DosePro. See the end of this leaflet for a complete list of ingredients in Sumavel DosePro.
What should I tell my healthcare provider before taking Sumavel DosePro?
Before you take Sumavel DosePro, tell your healthcare provider about all of your medical conditions, including if you:
- have high blood pressure
- have high cholesterol
- have diabetes
- are overweight
- have heart problems or family history of heart problems or stroke
- have liver problems
- have had epilepsy or seizures
- are not using effective birth control
- become pregnant while taking Sumavel DosePro
- are breastfeeding or plan to breastfeed. Sumavel DosePro passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Sumavel DosePro.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using Sumavel DosePro with certain other medicines can affect each other, causing serious side effects.
Especially tell your healthcare provider if you take anti-depressant medicines called:
- selective serotonin reuptake inhibitors (SSRIs)
- serotonin norepinephrine reuptake inhibitors (SNRIs)
- tricyclic antidepressants (TCAs)
- monoamine oxidase inhibitors (MAOIs)
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take Sumavel DosePro?
- See the Instructions for Use at the end of this leaflet for complete information on how to use Sumavel DosePro.
- Certain people should take their first dose of Sumavel DosePro in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
- Use Sumavel DosePro exactly as your healthcare provider tells you to use it.
- Before you try to inject Sumavel DosePro yourself, a healthcare provider should teach you how to use the Sumavel DosePro Needle-free Delivery System.
- Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.
- You should use Sumavel DosePro as soon as the symptoms of your headache start, but it may be given at any time during a migraine attack.
- If you did not get any relief after the first dose, do not give a second dose without first talking with your healthcare provider.
- You may use a second dose of Sumavel DosePro or 1 dose of another sumatriptan medicine separated by at least 1 hour, but not sooner, if your headache came back after your first dose.
- Do not use more than 2 doses of 6 mg or 3 doses of 4 mg Sumavel DosePro in a 24-hour period.
- If you use too much Sumavel DosePro, call your healthcare provider or go to the nearest hospital emergency room right away.
- You should write down when you have headaches and when you take Sumavel DosePro so you can talk with your healthcare provider about how Sumavel DosePro is working for you.
What should I avoid while taking Sumavel DosePro?
Sumavel DosePro 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.
What are the possible side effects of Sumavel DosePro?
Sumavel DosePro may cause serious side effects, including:
- See “What is the most important information I should know about Sumavel DosePro?”
- changes in color or sensation in your fingers and toes (Raynaud's syndrome)
- stomach and intestinal problems (gastrointestinal and
colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic
- sudden or severe stomach pain
- stomach pain after meals
- weight loss
- nausea or vomiting
- constipation or diarrhea
- bloody diarrhea
- problems with blood circulation to your legs and feet
(peripheral vascular ischemia).
Symptoms of peripheral vascular ischemia include:
- cramping and pain in your legs or hips
- feeling of heaviness or tightness in your leg muscles
- burning or aching pain in your feet or toes while resting
- numbness, tingling, or weakness in your legs
- cold feeling or color changes in 1 or both legs or feet
- medication overuse headaches. Some people who use too many Sumavel DosePro injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Sumavel DosePro.
- serotonin syndrome. Serotonin syndrome is a rare
but serious problem that can happen in people using Sumavel DosePro, especially
if Sumavel DosePro is used with anti-depressant medicines called SSRIs or
Call your healthcare provider 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
- seizures. Seizures have happened in people taking Sumavel DosePro who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Sumavel DosePro.
The most common side effects of Sumavel DosePro include:
- pain or redness at your injection site
- tingling or numbness in your fingers or toes
- warm, hot, burning feeling to your face (flushing)
- discomfort or stiffness in your neck
- feeling weak, drowsy, or tired
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Sumavel DosePro. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Sumavel DosePro Injection?
- Store Sumavel DosePro between 68oF to 77oF (20oC to 25oC).
- Do not freeze.
- Protect from light.
Keep Sumavel DosePro and all medicines out of the reach of children.
General information about the safe and effective use of Sumavel DosePro.
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Sumavel DosePro for a condition for which it was not prescribed. Do not give Sumavel DosePro to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Sumavel DosePro. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Sumavel DosePro that is written for healthcare professionals.
For more information, go to www.SumavelDosePro.com or call 1-866-ZOGENIX
What are the ingredients in Sumavel DosePro Injection?
Active ingredient: sumatriptan succinate
Inactive ingredients: sodium chloride, water for injection
Instructions for Use
(sumatriptan injection) Needle-free Delivery System
Read these Instructions for Use which come with Sumavel DosePro before you start using it and each time you get a refill. Follow these instructions each time you use Sumavel DosePro. Before you use Sumavel DosePro for the first time, make sure your doctor shows you the right way to use it.
A. Check your device:
The snap-off tip should sit firmly on the end of the clear medication chamber. Do not use Sumavel DosePro if the snap-off tip is tilted or broken off.
The medicine inside Sumavel DosePro should be clear and colorless or pale yellow. Do not use Sumavel DosePro if the medicine looks dark-colored or cloudy.
The expiration date is printed on both the Sumavel DosePro label and carton. Do not use Sumavel DosePro if the medicine is expired.
B. Choose a delivery site:
Select a delivery site such as your stomach area (abdomen) or your thigh.
Do not deliver Sumavel DosePro in the arm.
Your skin should be clean, dry, and free of clothing.
Do not deliver through your clothes.
Do not deliver into scars or moles, or within 2 inches of your belly button (navel). Do not deliver into the same spot. Change delivery sites with each use.
Shaded areas show all possible areas of delivery.
1. Snap: In this step, you will learn how to correctly remove the snap-off tip.
Do not begin these steps until you are ready to take your dose.
Firmly hold the handle of Sumavel DosePro in one hand. With the other hand, use your fingers to grip the top and bottom of the snap-off tip, where the finger grips are located.
To break off the snap-off tip, firmly snap it off in a downward motion. You may need to use some force.
You do not need to twist or pull the snap-off tip; doing so will not work.
2. Flip: In this step, you will learn how to prepare Sumavel DosePro for delivery of the medicine. Firmly press the lavender (4 mg) or green (6 mg) lever all the way down (away from the clear plastic end), until it clicks and locks into the handle. You may feel some resistance – this is normal.
Once you have flipped the lever, do not touch the end of the clear medication chamber. Keep the medication chamber pointed away from your face or eyes.
3. Pinch and Press: In this step, you will learn how to deliver the medicine. Deliver the dose exactly as shown to you by your healthcare provider.
Pinch about 2 inches of the skin of your stomach (abdomen) or thigh to create a firm section of skin.
Place Sumavel DosePro straight out from the delivery site with the end of the clear medication chamber against your skin.
Do not hold Sumavel DosePro at an angle to your skin.
During the next step, you will hear a loud burst of air. Do not be alarmed – this indicates that the medicine has been delivered.
Steadily press Sumavel DosePro straight down against your skin until you hear and feel a burst of air. There is no button to push. After you hear the burst of air (whoosh), the medicine has been delivered and you can remove Sumavel DosePro from your skin.
Let go of your pinched skin after the medicine has been delivered.
After removing Sumavel DosePro from your skin, a small droplet of blood may be present. You can gently press a cotton ball or gauze over the injection site. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Sumavel DosePro Information
Sumavel DosePro - User Reviews
Sumavel DosePro User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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