Sumavel DosePro - Consumer Medicine Information
|Manufacture:||Endo Pharmaceuticals Inc.|
|Condition:||Cluster Headaches, Migraine, Migraine Headache (Migraine)|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||sumatriptan succinate, sodium chloride, water for injection|
Needle-free Delivery System
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 treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
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 hours:
- 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 events include:
- 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 SNRIs.
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 the FDA at 1-800-FDA-1088.
How Should I Store Sumavel DosePro Injection
- Store Sumavel DosePro between 68 oF to 77 oF (20 oC to 25 oC).
- 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 Endo Pharmaceuticals at 1-800-462-3636
What are the Ingredients in Sumavel DosePro Injection
Sodium chloride, water for injection.