Indications
ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injector for subcutaneous use is a prescription medicine that contains sumatriptan and is used to treat adults who have been diagnosed with migraine or cluster headaches.
ALSUMA is not used to treat other types of headaches or used to prevent or lessen the number of migraine or cluster headaches
It is not known if ALSUMA is safe or effective in people younger than 18 or ≥65 years of age.
IMPORTANT SAFETY INFORMATION
ALSUMA may increase your chance of having a heart attack or stroke that can lead to death. This chance is higher in people who have heart disease. Very rarely, certain people, even some without heart disease, have had serious heart-related problems.
ALSUMA is not for people with risk factors for heart disease unless a heart examination is performed and shows no problems. The risk factors for heart disease include but are not limited to:
- High blood pressure
- High cholesterol levels
- Smoking
- Obesity
- Diabetes
- Having a family history of heart disease
- Being a female who has gone through menopause
- Being a male older than 40 years
Do not take ALSUMA if you have:
- Taken any triptans or ergotamine medicines within the last 24 hours, such as almotriptan (AXERT), eletriptan (RELPAX), frovatriptan (FROVA), naratriptan (AMERGE), rizatriptan (MAXALT), sumatriptan (IMITREX), sumatriptan and naproxen (TREXIMET), ergotamine (ERGOMAR, CAFERGOT, or MIGERGOT), and dihydroergotamine (D.H.E. 45, MIGRANAL)
- Narrowing of blood vessels to the legs, arms, stomach, or kidneys (e.g., peripheral vascular disease)
- Heart disease or a history of heart disease
- Uncontrolled high blood pressure
- Migraines that cause temporary paralysis on one side of your body
- Basilar migraine (rare form of migraine with symptoms including but not limited to: dizziness, double vision, loss of balance, confusion, slurred speech, hearing change)
- Had a stroke, transient ischemic attacks, or problems with your blood circulation
- Are allergic to sumatriptan or any of the other ingredients in ALSUMA
Serotonin syndrome is a serious and life-threatening problem that can be caused by ALSUMA, especially if used with antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Make sure to tell your healthcare professional if you take SSRIs, SNRIs, or monoamine oxidase inhibitors (MAOIs).
Call your healthcare professional if you have symptoms of serotonin syndrome, which include but are not limited to:
- Mental changes (e.g., seeing things that are not there, unusual tension, and restlessness)
- Fast heartbeat
- Changes in blood pressure
- High body temperature
- Tight muscles
- Trouble walking
- Nausea, vomiting, or diarrhea
Tell your healthcare professional about all of the medicines (both prescription and nonprescription), vitamins, and herbal supplements that you take.
Before taking ALSUMA, tell your healthcare professional about all of your medical conditions, including if you:
- Have high cholesterol
- Have diabetes
- Smoke
- Have gone through menopause
- Have heart disease or a family history of heart disease or stroke
- Have had epilepsy or seizures
- Are pregnant or plan to become pregnant. It is not known if ALSUMA will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. ALSUMA passes into your breast milk and may harm your baby.
Use of ALSUMA
- Take ALSUMA exactly as your healthcare professional tells you
- Take ALSUMA as soon as your symptoms of a migraine or cluster headache start, although it may be given at any time during an attack
- The usual dose is a single injection given just below the skin in the side of your thigh or upper arm. Do not inject ALSUMA into a vein or muscle.
- You may take a second injection from a second auto-injector, at least one hour after the first dose, if your migraine or cluster headache symptoms come back. Do not take more than 2 doses in a 24-hour period.
- If your symptoms do not get better after the first injection, do not give a second injection for the same attack without first talking with your healthcare provider
ALSUMA can cause serious side effects or even death. Serious side effects can include:
- Heart attacks
- Fast heartbeat
- Increase in blood pressure
- Stroke
- Changes in mental status (e.g., agitation, hallucinations, or coma)
- Changes in color or sensation in your fingers and toes (e.g., Raynaud syndrome)
- Poor blood flow to the arms or legs
- Poor blood flow to the gastrointestinal tract
Get medical help right away if you have:
- Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- Shortness of breath or wheezing
- Sudden or severe stomach pain
- Hives
- Swelling of your tongue, mouth, or throat
- Problems seeing
- Unusual weakness or numbness
- Nausea or vomiting
- Bloody diarrhea
- High temperature
- Unusual sweating
The most common side effects of ALSUMA include but are not limited to:
- Bleeding, swelling, redness, bruising, and pain at the injection site
- Tingling or numbness in your fingers or toes
- Dizziness
- Warm, hot, or burning feeling to your face (flushing)
- Feeling of heaviness or pressure
- Discomfort or tightness in the chest, neck, throat, nose, or jaw
- Feeling weak, drowsy, or tired
- Feeling strange
- Muscle pain
Keep ALSUMA and all medicines out of the reach of children.
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You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-332-1088.
