Sumavel DosePro (sumatriptan) is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.
Sumavel DosePro is used to treat migraine headaches and cluster headaches in adults. Sumavel DosePro will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.
Sumavel DosePro should not be used to treat a common tension headache or a headache that causes loss of movement on one side of your body. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.
Important information
You should not use Sumavel DosePro if you have any history of heart disease or coronary artery disease, blood circulation problems, Wolff-Parkinson-White syndrome, uncontrolled high blood pressure, severe liver disease, circulation problems affecting your intestines, history of a stroke, or if your headache seems to be different from your usual migraine headaches.
Do not use Sumavel DosePro if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Do not use Sumavel DosePro within 24 hours before or after using any migraine headache medicine..
Before using this medicine
You should not use Sumavel DosePro if you are allergic to sumatriptan, or if you have:
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coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
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a heart disorder called Wolff-Parkinson-White syndrome;
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a history of heart disease, heart attack, or stroke, including "mini-stroke";
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untreated or or uncontrolled high blood pressure;
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severe liver disease;
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circulation problems affecting your intestines; or
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a headache that seems different from your usual migraine headaches.
Do not use Sumavel DosePro if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure Sumavel DosePro is safe for you, tell your doctor if you have:
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liver or kidney disease;
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epilepsy or other seizure disorder;
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high blood pressure, a heart rhythm disorder; or
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risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).
Sumavel DosePro can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medicine.
It is not known whether Sumavel DosePro will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Sumavel. Your name may need to be listed on a sumatriptan pregnancy registry.
Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using a Sumavel DosePro. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
Sumavel DosePro should not be given to anyone under 18 or over 65 years of age.
How should I use Sumavel DosePro?
Use Sumavel DosePro exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.
A Sumavel DosePro dose is delivered into your stomach area (abdomen), or thigh. Do not deliver Sumavel DosePro into the arm or other body parts.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Use Sumavel DosePro as soon as you notice headache symptoms, or after an attack has already begun.
Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.
Sumavel DosePro is a needle-free injector device . Each vial, cartridge, or needle-free device is for one use only.
After using a dose: If your headache does not completely go away after the dose, call your doctor before using a second Sumavel DosePro. If your headache goes away and then comes back, you may use a second dose if it has been at least one hour since your first dose. Do not use more than two (2) doses of Sumavel in 24 hours. If your symptoms do not improve, contact your doctor before using any more doses.
Store Sumavel DosePro at room temperature away from moisture, heat, and light. Throw away any unused medicine after the expiration date on the label has passed.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include tremors, skin redness, scabs or scaly skin where you injected the medicine, weakness, lack of coordination, breathing problems, blue-colored lips or fingernails, vision problems, seizure (convulsions), or loss of movement in any part of your body.
What should I avoid while using Sumavel DosePro?
Do not use Sumavel DosePro within 24 hours before or after using another migraine headache medicine, including:
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sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
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ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).
Sumavel DosePro may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Sumavel DosePro side effects
Get emergency medical help if you have signs of an allergic reaction to Sumavel DosePro: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Sumavel DosePro and call your doctor if you have:
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sudden and severe stomach pain and bloody diarrhea;
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numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
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seizure (convulsions);
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dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats;
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heart attack symptoms - chest pain or pressure, tightness or pain spreading to your jaw or shoulder, nausea, sweating;
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signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
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(if you are also taking an antidepressant) - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common Sumavel DosePro side effects may include:
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numbness or burning sensation;
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pressure or heavy feeling in any part of your body;
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dizziness, drowsiness;
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feeling weak or tired;
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neck pain or stiffness;
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flushing (warmth, redness, or tingly feeling); or
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pain, redness, bleeding, swelling, or bruising where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Sumavel DosePro?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sumavel DosePro, especially:
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imatinib, isoniazid, nefazodone;
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an antibiotic - clarithromycin, erythromycin, telithromycin;
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an antidepressant - amitriptyline, citalopram, clomipramine, desipramine, doxepin, escitalopram, fluoxetine (Prozac), fluvoxamine, imipramine, nortriptyline, paroxetine, sertraline (Zoloft), trazodone, or vilazodone;
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antifungal medication - itraconazole, ketoconazole, posaconazole, voriconazole;
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heart medication - nicardipine, quinidine; or
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antiviral medicine to treat hepatitis C or HIV/AIDS - boceprevir, atazanavir, cobicistat (Stribild, Tybost), delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir.
This list is not complete. Other drugs may interact with sumatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
