Sumavel DosePro

Sumavel DosePro is a prescription medication used to treat migraine or cluster headaches once they have started. Sumavel DosePro belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

Sumavel DosePro comes in a pre-filled, single-use unit that uses a burst of gas to shoot the drug underneath the skin. It is intended to be used at the first sign of a migraine or cluster headache.

Common side effects of Sumavel DosePro include tingling or numbness in fingers or toes, weakness, tiredness. Sumavel DosePro can cause drowsiness. Do not drive a car or operate machinery if you have these symptoms.

Sumavel DosePro is a prescription medication used to treat migraine or cluster headaches, with or without aura, once they have started.

This medication may be prescribed for other uses.

Sumavel DosePro may cause serious side effects. See “Drug Precautions”.

The most common side effects of Sumavel DosePro include:

• injection site reactions such as redness, pain, or swelling
• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• discomfort or stiffness in your neck
• feeling weak, drowsy, or tired

Sumavel DosePro can also cause drowsiness. Do not drive or operate heavy machinery until you know how Sumavel DosePro affects you.

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 sumatriptan. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Sumavel DosePro and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) venlafaxine (Effexor)
• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

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
• chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
• 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
• smoke
• are overweight
• have diabetes
• have a family history of heart disease
• are a female who has gone through menopause
• are a male over age 40

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking Sumavel DosePro, especially if Sumavel DosePro is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

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
• nausea, vomiting, or diarrhea

Medication overuse headaches. Some people who take/use too much Sumavel DosePro may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Sumavel DosePro.

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.

Changes in color or sensation in your fingers and toes (Raynaud's syndrome).

Problems with blood circulation to your legs and feet (peripheral vascular ischemia). Tell your healthcare provider if you have any of the following symptoms of blood circulation problems:

• 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

Stomach and intestinal problems. Tell your healthcare provider if you have any of the following symptoms of stomach or intestinal problems:

• sudden or severe stomach pain
• stomach pain after meals
• weight loss
• nausea or vomiting
• constipation or diarrhea
• bloody diarrhea
• fever

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
• severe liver problems
• 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
• have ischemic bowel disease
• are currently taking a MAO inhibitor or have taken an MAO inhibitor in the last 2 weeks
• taken any of the following medicines in the last 24 hours:
  • almotriptan (Axert)
  • eletriptan (Relpax)
  • frovatriptan (Frova)
  • naratriptan (Amerge)
  • rizatriptan (Maxalt, Maxalt-MLT)
  • sumatriptan and naproxen (Treximet)
  • ergotamines (Cafergot, Ergomar, Migergot)
  • dihydroergotamine (D.H.E. 45, Migranal)
• an allergy to Sumavel DosePro or any of the ingredients in 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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sumavel DosePro there are no specific foods that you must exclude from your diet when receiving 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
• smoke
• are overweight
• are a female who has gone through menopause
• have heart disease or a family history of heart disease or stroke
• have liver problems
• have had epilepsy or seizures
• are not using effective birth control
• are pregnant or plan to become pregnant
• become pregnant while taking sumatriptan
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sumavel DosePro falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Sumavel DosePro crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Sumavel DosePro. Talk with your healthcare provider about the best way to feed your baby if you take Sumavel DosePro.

• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• 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.
• Take Sumavel DosePro exactly as your healthcare provider tells you to take it. Do not inject more or less of it or take it more often than prescribed by your doctor.
• Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.
• Your doctor or pharmacist should show you how to load the injector and administer the medication.
• For adults, the usual dose is a single injection given just below the skin in the abdomen or thigh. You should give an injection as soon as the symptoms of your migraine start, but it may be given at any time during an attack. You may give a second injection if your migraine symptoms come back.
• Do not administer Sumavel DosePro within 2 inches of the belly button or in the arms. Sumavel DosePro should only be administered below the skin in the abdomen or thighs. 
• If your symptoms do not get better after the first injection, do not give a second injection for the same attack without first talking with your healthcare provider. Do not give more than two 6-mg doses in any 24-hour period. Allow at least 1 hour between each dose.
• If you take 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.

Inject Sumavel DosePro exactly as prescribed. Follow the directions on your prescription label carefully.

The maximum recommended adult dose of Sumavel DosePro injection is 6 mg injected subcutaneously (under the skin). The maximum recommended dose that may be given in 24 hours is two 6 mg injections separated by at least one hour.

If side effects are bothersome with the 6 mg dose, a lower dose of 4 mg may be used for migraines. This lower dose has not been evaluated for use in cluster headaches. 

If you have taken more Sumavel DosePro than has been prescribed for you, contact either your doctor, hospital emergency department, or your local Poison Control Center.

• Store Sumavel DosePro between 68 °F to 77 °F (20 °C to 25 °C).
• Do not freeze.
• Protect from light.
• Keep your medicine in the packaging or carrying case provided with it.
• Keep Sumavel DosePro and all medicines out of the reach of children.