Alsuma

Alsuma

Generic Name: sumatriptan injection

Date of Approval: June 29, 2010

Company: King Pharmaceuticals, Inc.

Treatment for: Migraine; Cluster Headaches

FDA Approves Alsuma

Read the patient information that comes with Alsuma before you start taking 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 treatment. You and your healthcare provider should talk about Alsuma when you start taking it and at regular checkups.

Important information about Alsuma

Alsuma, which contains sumatriptan, may increase your chance of getting a heart attack or stroke that can lead to death. This chance is higher in people who have heart disease.

Alsuma is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.

The risk factors for heart disease include:

high blood pressure

high cholesterol levels

smoking

obesity

diabetes

family history of heart disease

female who has gone through menopause

male over age 40

"Seratonin syndrome" is a serious and life-threatening problem that can be caused by Alsuma, especially if 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 if you have symptoms of serotonin syndrome, which include:

mental changes (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, diarrhea

What is Alsuma?

The Alsuma auto-injector is a prescription medicine injection used to treat people who have been diagnosed with migraine or cluster headaches. Alsuma is not used to prevent or lessen the number of migraine or cluster headaches you have.

Alsuma is not used to treat other types of headaches.

It is not known if Alsuma is safe or effective in people under 18 years of age.

Who should not take Alsuma?

Do not take Alsuma if you have:

narrowing of blood vessels to the legs, arms, stomach or kidneys (peripheral vascular disease)

heart disease or a history of heart disease

uncontrolled high blood pressure

migraines that cause temporary paralysis (unable to move) on one side of your body or basilar migraine. If you are not sure about this, 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)

sumatriptan (Imitrex)

sumatriptan and naproxen (Treximet)

ergotamines like Ergomar, Cafergot or Migergot

dihydroergotamine (D.H.E. 45, Migranal)

are allergic to sumatriptan or any of the other ingredients in Alsuma. See the end of this leaflet for a complete list of ingredients in Alsuma.

Before taking Alsuma

Before taking Alsuma, tell your healthcare provider about all 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

are pregnant or plan to become pregnant. It is not known if Alsuma will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

are breast feeding or plan to breast feed. Alsuma passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Alsuma.

have had epilepsy or seizures

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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)

Monoamine Oxidase Inhibitors (MAO-A)

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

How should I take Alsuma?

Take Alsuma exactly as your healthcare provider tells you.

Give the injection in the side of your thigh, or the upper arm just below the skin (subcutaneous). Check with your doctor if you are not sure where to inject yourself.

Do not give Alsuma into a vein.

Take Alsuma as soon as your symptoms of a migraine or cluster headache start, but it may be given at any time during an attack.

You may take a second injection at least one hour after your first dose if your migraine or cluster headache symptoms come back.

Do not take more than two doses of Alsuma in 24 hours.

If you do not feel better after the first injection, do not give a second injection for the same attack without talking with your healthcare provider.

Alsuma side effects

Alsuma can cause serious side effects or even death. See "What is the most important information I should know about Alsuma?"

Serious side effects include:

heart attacks

fast heartbeat

increase in blood pressure

stroke

changes in mental status (agitation, hallucinations, coma)

changes in color or sensation to your fingers and toes (Raynaud's syndrome)

poor blood flow to your arms or legs

poor blood flow to your 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 (raised bumps), 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:

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)

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

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of 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-30°C).

Keep Alsuma out of the 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 a patient information leaflet. 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 that 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 health professionals. For more information, go to www.ALSUMAAI.com or call 1-877-770-8796.

What are the Ingredients in Alsuma?

Active ingredient: sumatriptan

Inactive ingredient: sodium chloride