ALSUMA- sumatriptan injection, solution
Pfizer Laboratories Div Pfizer Inc
Read this Patient Information before you start taking ALSUMA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
ALSUMA can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking ALSUMA and get emergency medical help right away if you have any of the following symptoms of a heart attack:
ALSUMA 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:
What is ALSUMA?
ALSUMA Auto-Injector is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.
ALSUMA is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
ALSUMA is not used to prevent or decrease the number of migraine or cluster headaches you have.
It is not known if ALSUMA is safe and effective in children under 18 years of age.
Who should not take ALSUMA?
Do not take ALSUMA if you have:
Ask your healthcare provider if you are not sure if your medicine is listed above.
What should I tell my healthcare provider before taking ALSUMA?
Before you take ALSUMA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using ALSUMA with certain other medicines can affect each other, causing serious side effects.
Especially tell your healthcare provider if you take anti-depressant medicines called:
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.
How should I take ALSUMA?
What should I avoid while taking ALSUMA?
ALSUMA 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.
What are the possible side effects of ALSUMA?
ALSUMA can cause serious side effects. See "What is the most important information I should know about ALSUMA?"
These serious side effects include:
Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
The most common side effects of ALSUMA include:
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 ALSUMA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ALSUMA?
Store ALSUMA between 59°F to 86°F (15°C to 30°C).
Keep ALSUMA and all medicines out of the reach of children.
General information about the safe and effective use of ALSUMA
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ALSUMA for a condition for which it was not prescribed. Do not give ALSUMA to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about ALSUMA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ALSUMA that is written for healthcare professionals.
For more information, go to www.alsuma.com or call 1-877-770-8796.
What are the ingredients in ALSUMA?
Active ingredient: sumatriptan succinate
Inactive ingredients: sodium chloride, water for injection
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.