Alsuma

Alsuma is a prescription medication used to treat migraines and cluster headaches once they have started. Alsuma belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

Alsuma is available as an injectable form to be injected under the skin.

Common side effects of Alsuma include injection site reactions and tingling or numbness in fingers or toes. Alsuma can cause drowsiness and dizziness. Do not drive a car or operate machinery if you have these symptoms.

Alsuma is a prescription medication used to treat migraines once they have started, with or without aura.

Alsuma is also used to treat cluster headaches once they have started

This medication may be prescribed for other uses.

• Meridian Medical Technologies, Inc.

Alsuma may cause serious side effects. See “Drug Precautions”.

The most common side effects of Alsuma include:

• injection site reactions such as redness, pain, or swelling
• tingling or numbness in your fingers or toes
• dizziness
• warm, hot, burning feeling to your face (flushing)
• discomfort or stiffness in your neck
• feeling weak, drowsy, or tired

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.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Alsuma and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox)
• serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) venlafaxine (Effexor)
• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

Alsuma can cause serious side effects, including:

• Raynaud’s syndrome: changes in color or sensation in your fingers and toes.
• stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
• problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• medication overuse headaches. Some people who take/use too much Alsuma may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Alsuma.

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:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded

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:

• have high blood pressure
• have high cholesterol levels
• smoke
• are overweight
• have diabetes
• have a family history of heart disease
• are a female who has gone through menopause
• are a male over age 40

Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking Alsuma, especially if Alsuma is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

• mental changes such as seeing things that are not there (hallucinations), agitation, or coma
• fast heartbeat
• changes in blood pressure
• high body temperature
• tight muscles
• trouble walking
• nausea, vomiting, or diarrhea

Medication overuse headaches. Some people who take/use too much Alsuma may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Alsuma.

Seizures. Seizures have happened in people taking Alsuma who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Alsuma.

Do not take Alsuma if you have:

• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• taken any of the following medicines in the last 24 hours:
  • almotriptan (Axert)
  • eletriptan (Relpax)
  • frovatriptan (Frova)
  • naratriptan (Amerge)
  • rizatriptan (Maxalt, Maxalt-MLT)
  • sumatriptan and naproxen (Treximet)
  • ergotamines (Cafergot, Ergomar, Migergot)
  • dihydroergotamine (D.H.E. 45, Migranal)
• an allergy to Alsuma or any of its ingredients

Alsumacan 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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Alsuma there are no specific foods that you must exclude from your diet when receiving Alsuma.

Before you take Alsuma, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• are a female who has gone through menopause
• have heart disease or a family history of heart disease or stroke
• have liver problems
• have had epilepsy or seizures
• are not using effective birth control
• are pregnant or plan to become pregnant
• become pregnant while taking sumatriptan
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Alsuma falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Alsuma may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Alsuma.

Infant exposure to Alsuma can be minimized by avoiding breastfeeding for 12 hours after treatment with Alsuma.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Alsuma comes in an auto injection that you can self-inject into your thigh or upper arm under the skin.  

• Certain people should take their first dose of Alsuma in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
• Use Alsuma exactly as your healthcare provider tells you to use it.
• Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
• Do not give Alsuma into a vein.
• Give the injection in the side of your thigh, or the upper arm just below the skin (subcutaneous). Check with your healthcare provider if you are not sure where to inject yourself.
• You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine attack.
• If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
• You can take a second injection 1 hour after the first injection, but not sooner, if your headache came back after your first injection.
• Do not take more than 2 doses of Alsuma in 24 hours.
• You should write down when you have headaches and when you take Alsuma so you can talk with your healthcare provider about how Alsuma is working for you.

Take Alsuma exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended adult dose of Alsuma (sumatriptan) injection is 6 mg injected subcutaneously (under the skin).

The maximum recommended dose that may be given in 24 hours is two 6 mg injections separated by at least one hour.

If you use too much Alsuma, call your healthcare provider or go to the nearest hospital emergency room right away.

• Store Alsuma between 59°F to 86°F (15°C to 30°C).
• Store your medicine away from light.
• Do not put Alsuma in the refrigerator.
• Keep each Alsuma Auto-Injector in its storage and disposal case.
• Remove the Alsuma Auto-Injector from the storage and disposal case only when you need to give yourself an injection.
• Keep Alsuma and all medicines out of the reach of children.