The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Generic Name: sumatriptan (SOO-ma-TRIP-tan)
Brand Name: Sumavel DosePro
Sumavel DosePro is used for:
Treating migraine headaches with or without aura (eg, flashing lights, wavy lines, dark spots). It is also used to treat cluster headaches.
Sumavel DosePro is a serotonin 5-HT1 receptor agonist ("triptan"). It works by narrowing blood vessels in the brain, which helps to relieve migraine and cluster headaches.
Do NOT use Sumavel DosePro if:
- you are allergic to any ingredient in Sumavel DosePro
- you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, certain types of irregular heartbeat (eg, Wolff-Parkinson-White syndrome), brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
- you have uncontrolled high blood pressure or severe liver problems
- you have certain types of migraines (eg, hemiplegic, basilar)
- you have used certain other migraine medicines within the past 24 hours (eg, an ergot derivative [eg, dihydroergotamine, methysergide], another serotonin 5-HT1 receptor agonist [eg, eletriptan, rizatriptan])
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sumavel DosePro:
Some medical conditions may interact with Sumavel DosePro. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of liver or kidney problems, seizures (eg epilepsy), or heart problems
- if you have shortness of breath, chest pain, or a history of high blood pressure, heart attack, stroke, high cholesterol, diabetes, or smoking
- if you are a woman who is past menopause
- if you are a man who is older than 40 years old
- if you are very overweight
- if a family member has had heart disease or a stroke
Some MEDICINES MAY INTERACT with Sumavel DosePro. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
- Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because they may increase the risk of Sumavel DosePro's side effects
- Ergot derivatives (eg, dihydroergotamine, methysergide) or other serotonin 5-HT1 receptor agonists (eg, eletriptan, rizatriptan) because the risk of their side effects may be increased by Sumavel DosePro
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sumavel DosePro may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sumavel DosePro:
Use Sumavel DosePro as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Sumavel DosePro. Talk to your pharmacist if you have questions about this information.
- A health care provider will teach you how to use Sumavel DosePro. Be sure you understand how to use Sumavel DosePro. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Sumavel DosePro if it contains particles, is cloudy or discolored, or if the device is cracked or damaged. Do not use it if the tip of the device is tilted or broken off.
- Use Sumavel DosePro only on a clean, dry area of skin on your stomach area or thigh. Do not use Sumavel DosePro on your arms or other areas of the body. Do not use Sumavel DosePro over scars, moles, or within 2 inches of your belly button (navel). Only use Sumavel DosePro on bare skin; do not use through clothing.
- Sumavel DosePro will relieve migraine pain at any time during an attack. It is best to inject a dose of Sumavel DosePro as soon as you notice symptoms of a migraine attack.
- If your migraine symptoms go away and then come back, you may use a second dose as directed by your doctor. Wait at least 1 hour between doses. If you need a second dose of Sumavel DosePro, deliver it in a different area of skin from the first dose.
- If your symptoms do not get better after the first injection, do not use a second dose for the same attack. Contact your doctor.
- Do not use more than 2 doses in a 24-hour period or treat more than 4 headaches within 30 days without checking with your doctor.
- Keep this product out of the reach of children and away from pets. Ask your health care provider how to dispose of Sumavel DosePro after use. Follow all local rules for disposal.
- If you miss a dose of Sumavel DosePro and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do not use Sumavel DosePro more often than prescribed. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Sumavel DosePro.
Important safety information:
- Sumavel DosePro may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sumavel DosePro with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Overuse of Sumavel DosePro can cause your headache to become worse. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
- Rarely, serious and sometimes fatal heart problems (eg, heart attack, irregular heartbeat) have happened within a few hours of using Sumavel DosePro. Contact your doctor at once if fast or irregular heartbeat; chest, throat, jaw, or neck tightness, pain, pressure, or heaviness; breaking out in a cold sweat; shortness of breath; numbness or tingling of an arm or leg; severe stomach pain, dizziness, or vomiting; or fainting occur. Discuss any questions or concerns with your doctor.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Sumavel DosePro. Your risk may be greater if you take Sumavel DosePro with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Serious and sometimes fatal brain blood vessel problems like stroke have rarely happened with Sumavel DosePro. Contact your doctor at once if you have confusion, one-sided weakness, or speech or vision changes.
- Sumavel DosePro should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different than your usual migraine headaches, check with your doctor before using Sumavel DosePro.
- Severe and sometimes fatal allergic reactions have rarely happened. Discuss any questions or concerns with your doctor.
- You will need to check your blood pressure often. Talk with your doctor.
- Lab tests, including heart function, may be performed while you use Sumavel DosePro. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Sumavel DosePro with caution in the ELDERLY; the risk of serious side effects (eg, heart problems, high blood pressure) may be increased.
- Sumavel DosePro is not approved for use in CHILDREN younger than 18 years old. Talk with the doctor.
- PREGNANCY and BREAST-FEEDING: It is not known if Sumavel DosePro can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sumavel DosePro while you are pregnant. Sumavel DosePro is found in breast milk. If you are or will be breast-feeding while you use Sumavel DosePro, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Sumavel DosePro:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; dizziness; drowsiness; feeling strange; mild, temporary flushing; nausea; neck stiffness; pain, swelling, redness, bruising, or bleeding at the injection site; sick feeling; stomach upset; throat or sinus discomfort; tiredness; vomiting; warm or hot sensation; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; burning or aching in your feet or toes; burning, numbness, or tingling; constipation; diarrhea; fainting; feeling of heaviness or tightness in your leg muscles; fever; hearing problems or loss of hearing; leg cramps; seizures; severe or persistent headache, dizziness, nausea, or vomiting; severe stomach pain; trouble swallowing; very cold or blue fingers or toes; vision changes or loss of vision; weight loss; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Sumavel DosePro:
Store Sumavel DosePro between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Throw away expired medicine as directed by your doctor (the expiration date is printed on the carton). Keep Sumavel DosePro out of the reach of children and away from pets.
- If you have any questions about Sumavel DosePro, please talk with your doctor, pharmacist, or other health care provider.
- Sumavel DosePro is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Sumavel DosePro or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sumavel DosePro. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sumavel DosePro. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Sumavel DosePro.