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Alsuma

Alsuma

PATIENT INFORMATION

ALSUMA™
(Awl-SOO'-mah)
(sumatriptan injection) Auto-Injector

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.

What is the most important information I should know about ALSUMA?

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:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • 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:

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:

  • 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
  • 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 (IMITREX®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)

Ask your healthcare provider if you are not sure if your medicine is listed above.

  • an allergy to sumatriptan or any of the ingredients in ALSUMA. See the end of this leaflet for a complete list of ingredients in ALSUMA.

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:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking ALSUMA
  • are breastfeeding or plan to breastfeed. ALSUMA passes 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.

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:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants (TCAs)
  • monoamine oxidase inhibitors (MAOIs)

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?

  • Read the Instructions for Use that come with ALSUMA.
  • 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.

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

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.

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:

  • stroke
  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • 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
  • medication overuse headaches. Some people who use too many ALSUMA injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with ALSUMA.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using ALSUMA, especially if ALSUMA is used with anti-depressant medicines called SSRIs or SNRIs.
    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
  • 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.

The most common side effects of ALSUMA include:

  • bleeding, swelling, redness, bruising and pain at the injection site
  • 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store ALSUMA?

  • 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.

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

PATIENT INSTRUCTIONS FOR USE

ALSUMA™
(Awl-SOOŽ-mah)
(sumatriptan injection) Auto-Injector

Read the Patient Instructions for Use that come with the ALSUMA™ Auto-Injector before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Before you use ALSUMA for the first time, make sure your healthcare provider teaches you the right way to use it.

Follow these instructions each time you use ALSUMA.

ALSUMA is a disposable one time use, prefilled auto-injector used for the treatment of acute migraine or cluster headaches.

Each ALSUMA Auto-Injector is filled with medicine and ready to use. No assembly is required.

ALSUMA is packaged with two doses to a box, with each ALSUMA dose stored in a separate storage and disposal case. (see Figure 1)

Figure 1

ALSUMA Auto Injector - Illustration

ALSUMA Important Tips

  • Do not remove the Blue Safety Release until you are ready to inject yourself.
  • Do not place your fingers on the top or the bottom end of the ALSUMA Auto-Injector.
  • Do not touch the orange needle end.
  • Always point the orange needle end down.
  • Do not take apart the ALSUMA Auto-Injector.
  • Keep out of the reach of children.

The Storage and Disposal Case (see Figure 2)

  • Always store and carry ALSUMA in the storage and disposal case.
  • Do not remove ALSUMA from the storage and disposal case until you are ready to use it.
  • Always keep the orange needle end facing the bottom of the storage and disposal case.
  • The purple cap should be screwed tightly onto the storage and disposal case before use.
  • After your injection, the ALSUMA Auto-Injector should be placed back into the storage and disposal case. Throw away the case the way your healthcare provider told you.

Figure 2

Storage and Disposal Case - Illustration

The ALSUMA Auto-Injector

  • Locked : When the Blue Safety Release is in place, ALSUMA is locked and will not inject. (see Figure 3 )

Figure 3

Blue Safety Release - Illustration

  • Unlocked : When the Blue Safety Release is taken off, ALSUMA is unlocked and ready to use. (see Figure 4 )

Figure 4

Blue Safety Release - Illustration

Holding the ALSUMA Auto-Injector

Always hold the ALSUMA Auto-Injector in the middle with the orange needle end pointing down. (see Figure 5)

  • Never hold the injector upside down. (see Figure 6)
  • Never put your thumb on either end of the injector. (see Figures 7 and 8)
  • Never touch the orange needle end. (see Figure 8)

Figure 5, 6, 7 and 8

Holding the ALSUMA Auto-Injector -  Illustration

How to Use ALSUMA

1. Choose an injection site.

  • Ask your doctor about where you should inject yourself (usually the side of your thigh or your upper arm). (see Figures 9 and 10)
  • Do not inject through your clothes.

2. Preparing your ALSUMA Auto-Injector.

Figure 9 and 10

Injection site - Illustration

An Inside Look

Figure 11 and 12

ALSUMA Auto Injector - - Illustration

  • Twist off the purple cap from the storage and disposal case. (see Figure 13)

Figure 13

Twist off the purple cap - Illustration

  • Slide the ALSUMA Auto-Injector out into your hand. (see Figure 14)

Figure 14

Slide the ALSUMA Auto-Injector out into your hand - Illustration

  • Hold the ALSUMA Auto-Injector in the middle. (see Figure 15)

Figure 15

Hold the ALSUMA Auto-Injector in the middle - Illustration

  • Pull off the Blue Safety Release to unlock the ALSUMA Auto-Injector. (see Figure 16)

Figure 16

Pull off the Blue Safety Release - Illustration

3. Giving your injection.

Give yourself the injection exactly the way your healthcare provider showed you.

  • Place the orange needle end on your skin where you will give the injection. (see Figures 17 and 18)
  • Push the ALSUMA Auto-Injector hard into your skin until you feel a jolt. (see Figures 17 and 18)

Figure 17 and 18

Place the orange needle end on your skin - Illustration

  • Hold the ALSUMA Auto-Injector in place for 5 seconds to deliver the medicine. (see Figures 17 and 18)

4. After your injection, throw away (dispose of) the ALSUMA Auto-Injector.

  • Place the uncapped, empty storage and disposal case onto a flat surface. (see Figure 19)
  • Slowly insert the orange needle end of the used injector into the open end of the storage and disposal case. Slide the entire used injector into the case. (see Figure 19)
  • Tilt up the open end of the storage and disposal case and screw on the purple cap. (see Figure 20)

Figure 19 and 20

Tilt up the open end of the storage and disposal case and screw on the purple cap - Illustration

Check with your healthcare provider about the right way to throw away your used ALSUMA Auto-Injector. Each ALSUMA Auto-Injector can be used only one time.

Important Tips on Storing and Using Your Auto-Injector

  • Store the ALSUMA Auto-Injector between 59°F to 86°F (15°C-30°C).
  • Keep the ALSUMA Auto-Injector out of the light.
  • Do not put the ALSUMA Auto-Injector 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.

Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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