Sumatriptan Succinate, Injection

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KEY POINTS

• This medicine is given by injection to treat migraine headaches. It will not prevent migraine headaches or reduce the number you may have. Use it exactly as directed.
• This medicine may cause serious heart problems, stroke, increased blood pressure, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antimigraine

Generic and brand names: sumatriptan succinate, injection; Sumavel DosePro; sumatriptan, injection; Alsuma; Imitrex Injection; Zembrace SymTouch

What is this medicine used for?

This medicine is given by injection (shots) to relieve the pain of acute migraine headaches in adults. It will not prevent migraine headaches or reduce the number you may have. Some brands may also be used to treat cluster headaches.

This medicine is not intended to treat other types of headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A heart attack, irregular heartbeat, angina, or other heart disease
• A stroke or transient ischemic attack (TIA)
• Hemiplegic or basilar migraine headaches
• High blood pressure
• Liver, kidney, or bowel disease
• Peripheral vascular disease or Raynaud syndrome (problems with blood circulation)
• Seizures

Talk with your healthcare provider if you have any risk factors for heart disease such as diabetes, high cholesterol, smoking, being overweight, past menopause, or if you have a family history of heart disease or stroke. Women who have had a hysterectomy or are past menopause and men over the age of 40 are also at risk for heart disease.

Taking this medicine within 1 to 14 days of taking certain other medicines may cause life-threatening side effects. These medicines include some antidepressants, antibiotics, antifungal medicines, antiviral medicines, medicines to treat migraines, pain medicines, some cough medicines, St. John’s wort, and others. It is very important to tell your provider ALL of the medicines that you have taken in the past 2 weeks.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

The shots are given just under the skin. Your healthcare provider will determine the exact dosage. You can give yourself these shots or have someone at home give them to you. Be sure you know how and when to have shots. Read the Patient Instructions for Use that come with the medicine before you start using it and each time you get a refill. There may be new information. Carefully read and follow the directions that come in the package of medicine for preparing the shots. Wash your hands before using this medicine.

Check with your healthcare provider before using this medicine in children under the age of 18.

It is best to use this medicine as soon as your symptoms of a migraine or cluster headache start, but it may be given at any time during an attack.

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. You may be told to give a second injection at least 1 hour after your first dose. Do not take more than two doses of this medicine in 24 hours. Do not take other migraine medicines within 24 hours of a dose of this medicine.

Use each injection device only once and dispose of it safely, following your healthcare provider's instructions.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: tremors, skin redness, trouble breathing, slow breathing, blue-colored lips or fingernails, large pupils, weakness, lack of coordination, being unable to move, seizures.

What should I watch out for?

This medicine may cause serious heart problems, stroke, or increased blood pressure. If you develop tightness or pain in your chest, jaw, or neck, contact your healthcare provider right away.

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination or trouble walking
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea and vomiting
• Stiff muscles
• Diarrhea

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Do not smoke while using this medicine. Smoking may increase your risk of side effects.

If you have more than 4 migraine attacks a month, ask your healthcare provider what to do. Using migraine medicines for 10 days or more per month may cause medicine overuse headaches. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; seizures.

Serious (Report these to your healthcare provider right away.): Jaw or neck tightness, chest pain, irregular or fast heartbeat, severe headache, sudden or severe stomach pain, vision changes.

Other: Bleeding, swelling, redness, bruising and pain at the injection site; mild nausea or vomiting; dizziness; drowsiness; tiredness; mild flushing or tingling sensation; muscle pain; nose or throat discomfort; sweating weakness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antidepressants such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), levomilnacipran (Fetzima), sertraline (Zoloft), and venlafaxine (Effexor)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar) (Do not take these within 24 hours of a dose of this medicine.)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Metoclopramide (Metozolv, Reglan)
• Natural remedies such as kava, SAMe, St. John's wort, and tryptophan
• Nausea medicines such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and palonosetron (Aloxi)
• Nefazodone
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), sumatriptan/naproxen (Treximet), and zolmitriptan (Zomig) (Do not take these within 24 hours of a dose of this medicine.)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Tramadol (ConZip, Ultram)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the medicine in its original containers. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.