Alsuma injection

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

Stop using sumatriptan 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 (convulsions);

• blood circulation problems--cramps in your hips or legs, tight or heavy feeling in your legs, numbness or tingling in your legs, muscle weakness, burning pain in your feet, pale or blue-colored appearance in your toes;

• 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 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.

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.

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 - cramps in your hips or legs, tight or heavy feeling in your legs, numbness or tingling in your legs, muscle weakness, burning pain in your feet, pale or blue-colored appearance in your toes;

• 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.