Alsuma 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.

Alsuma auto-injector is used to treat migraine headaches and cluster headaches in adults. Alsuma will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Alsuma 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.

You should not use Alsuma if you have ever had heart disease, coronary artery disease, blood circulation problems, Wolff-Parkinson-White syndrome, uncontrolled high blood pressure, severe liver disease, a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not use Alsuma 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 Alsuma within 24 hours before or after using another migraine headache medicine..

Before using this medicine

You should not use Alsuma if you are allergic to sumatriptan, or if you have ever had:

• heart disease, heart attack, or stroke (including "mini-stroke");

• coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

• circulation problems affecting your legs, arms, stomach, intestines, or kidneys;

• a heart disorder called Wolff-Parkinson-White syndrome;

• uncontrolled high blood pressure;

• severe liver disease; or

• a headache that seems different from your usual migraine headaches.

Do not use Alsuma 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 Alsuma is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• epilepsy or other seizure disorder;

• high blood pressure, a heart rhythm disorder; or

• 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).

Alsuma 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 Alsuma will harm an unborn baby. Tell your doctor if you are pregnant. Your name may need to be listed on a sumatriptan pregnancy registry.

Sumatriptan can pass into breast milk, but effects on the nursing baby are not known. To avoid exposing your baby to sumatriptan in breast milk, do not breast-feed for 12 hours after using an injection. If you use a breast pump during this time, throw out any milk you collect.

Alsuma is not approved for use by anyone younger than 18 years old.

Use Alsuma auto-injector 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.

Alsuma is injected under the skin. You will be shown how to use the Auto-Injector at home. Do not self inject this medicine if you do not fully understand how to give the injection.

Alsuma Auto-Injector comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use Alsuma 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.

Alsuma is a disposable one time use, pre-filled auto-injector.

After using an injection: If your headache does not completely go away after the injection, call your doctor before using a second Alsuma injection. If your headache goes away and then comes back, you may use a second injection if it has been at least one hour since your first injection. Do not use more than two (2) injections in 24 hours. If your symptoms do not improve, contact your doctor before using any more injections.

Store Alsuma at room temperature away from moisture, heat, and light. Throw away any unused auto-injectors after the expiration date on the label has passed.

You should not use Alsuma if you are allergic to sumatriptan, or if you have ever had:

• heart disease, heart attack, or stroke (including "mini-stroke");

• coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

• circulation problems affecting your legs, arms, stomach, intestines, or kidneys;

• a heart disorder called Wolff-Parkinson-White syndrome;

• uncontrolled high blood pressure;

• severe liver disease; or

• a headache that seems different from your usual migraine headaches.

Do not use Alsuma 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 Alsuma is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• epilepsy or other seizure disorder;

• high blood pressure, a heart rhythm disorder; or

• 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).

Alsuma 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 Alsuma will harm an unborn baby. Tell your doctor if you are pregnant. Your name may need to be listed on a sumatriptan pregnancy registry.

Sumatriptan can pass into breast milk, but effects on the nursing baby are not known. To avoid exposing your baby to sumatriptan in breast milk, do not breast-feed for 12 hours after using an injection. If you use a breast pump during this time, throw out any milk you collect.

Alsuma is not approved for use by anyone younger than 18 years old.

Since Alsuma is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using Alsuma.

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.

Do not use Alsuma within 24 hours before or after using another migraine headache medicine, including:

• sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or

• ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Alsuma may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction to Alsuma: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Alsuma and call your doctor if you have:

• sudden and severe stomach pain and bloody diarrhea;

• severe chest pain, shortness of breath, irregular heartbeats;

• a seizure (convulsion);

• blood circulation problems in your legs or feet - cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;

• dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety;

• heart attack symptoms - chest pain or pressure, tightness or pain spreading to your jaw or shoulder, nausea, sweating;

• 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

• high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common Alsuma side effects may include:

• numbness or burning sensation;

• pressure or heavy feeling in any part of your body;

• dizziness, drowsiness, feeling weak or tired;

• neck pain or stiffness;

• flushing (warmth, redness, or tingly feeling); or

• 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.

Using Alsuma while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

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.