Drug Information for IMITREX (sumatriptan succinate) InjectionFor Subcutaneous Use Only. (GlaxoSmithKline LLC): PATIENT INFORMATION

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  • The following wording is contained in a separate leaflet provided for patients.

    Read this leaflet carefully several times before you start to use the IMITREX STATdose System. If you have any questions, ask your healthcare provider.

    Keep the IMITREX STATdose System out of the reach of children.

  • Before you use the IMITREX STATdose System

  • When you first open the IMITREX STATdose System box, the Cartridge Pack and the IMITREX STATdose Pen® are already in the Carrying Case for your convenience.

    The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.

    The Cartridge Pack holds 2 individually sealed Syringe Cartridges. Each Syringe Cartridge holds 1 dose of IMITREX® (sumatriptan succinate) Injection. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue (as shown). Refill Cartridge Packs are available.

    The grey and blue Pen is used to automatically inject 1 dose of medicine from a Syringe Cartridge. Do not touch the Blue Button until you have pressed the Pen against your skin to give a dose. If you press it at any other time, you might lose a dose. The Safety Catch keeps the Pen from accidentally firing until you are ready. The Pen will only work when you slide the grey part of the barrel down to the blue part. Always check to make sure that the white Priming Rod is not sticking out from the end of the Pen (as shown in Figure 2) before you load a new Syringe Cartridge. If it is sticking out, you will lose that dose.

  • How to load the IMITREX STATdose Pen

  • Do not load the Pen until you are ready to give yourself an injection. Do not touch the Blue Button on top of the Pen (see Figure 1) while you are loading the Pen.

    1. Open the lid of the Carrying Case.

    The tamper-evident seals over the 2 Syringe Cartridges are labeled “A” and “B” (see Figure 1 inset). Always use the Syringe Cartridge marked “A” before the one marked “B” to help you keep track of your doses. Do not use if either seal is broken or missing when you first open the Carrying Case.

    2. Tear off one of the tamper-evident seals (see Figure 1). Throw away the seal. Open the lid over the Syringe Cartridge.

    3. Hold the Pen by the ridges at the top. Take it out of the Carrying Case (see Figure 2).

    Check to make sure the white Priming Rod is not sticking out from the lower end of the Pen (see Figure 2 inset). If it is sticking out, put the Pen back into the Carrying Case and press down firmly until you feel it click. Then take the Pen out of the Carrying Case.

    4. Put the Pen in the Cartridge Pack. Turn it to the right (clockwise) until it will not turn any more (about half a turn) (see Figure 3).

    5. Hold the loaded Pen by the ridges and pull it straight out (see Figure 4). You may need to pull hard on the Pen, but this is normal. Do not press the Blue Button yet.

    The Pen is now ready to use. Do not put the loaded Pen back into the Carrying Case because that will damage the needle.

  • How to use the IMITREX STATdose Pen to take your medicine

  • Before injecting your medicine, choose an area with a fatty tissue layer (see Figure 5a or Figure 5b). Ask your healthcare provider if you have a question about where to inject. Clean the skin around this area.

    or

    1. Without pushing the Blue Button, press the loaded Pen firmly against the skin so that the grey barrel slides down toward the blue section that holds the Syringe Cartridge (see Figure 4). (This releases the Safety Catch that keeps the Pen from firing by mistake until you are ready.)

    2. Push the Blue Button. Hold the Pen still for at least 5 seconds. If the Pen is taken away from the skin too soon, not all the medicine will come out.

    3. After 5 seconds, carefully take the Pen away from your skin. The needle will be showing (see Figure 6). Do not touch the needle.

  • How to unload the IMITREX STATdose Pen after taking your medicine

  • Right after you take a dose with the Pen, you need to return the used Syringe Cartridge to the Cartridge Pack.

    1. Push the Pen down into the empty side of the Cartridge Pack as far as it will go (see Figure 7).

    2. Turn the Pen to the left (counterclockwise) about half a turn until it is released from the Syringe Cartridge (see Figure 8).

    3. Pull the empty Pen out of the Cartridge Pack (see Figure 9).

    Because the Pen has now been used, the white Priming Rod will stick out from the lower end of the Pen.

    4. Close the Cartridge Pack lid over the used Syringe Cartridge. When the used Syringe Cartridges are inserted correctly, the Cartridge Pack is a disposable, protective case to help you avoid needle sticks and use the syringes correctly.

    5. Put the Pen back into the Carrying Case and press it down firmly until you feel it click. Close the Carrying Case lid. This gets the Pen ready for the next use.

    If the lid will not close, push the Pen down until you feel it click. Then close the lid.

  • How to take out a used Cartridge Pack

  • After both Syringe Cartridges have been used, take the Cartridge Pack out of the Carrying Case and throw it away. Never reuse a Syringe Cartridge.

    1. Open the Carrying Case lid.

    2. Hold the Carrying Case with one hand and press the 2 buttons on either side of the Carrying Case (see Figure 10).

    3. Gently pull out the Cartridge Pack with the other hand (see Figure 11).

    (continued on other side)

  • How to insert a new Cartridge Pack

  • 1. Take the new Cartridge Pack out of its box. Do not take off the tamper-evident seals (see Figure 12).

    2. Put the Cartridge Pack in the Carrying Case. Slide it down smoothly (see Figure 13).

    3. The Cartridge Pack will click into place when the 2 buttons show through the holes in the Carrying Case (see Figure 14). Close the lid.

    February 2008

    IMJ:2PIL

    Information for the Patient

    IMITREX® (sumatriptan succinate) Injection

    Read this leaflet carefully before you start to take IMITREX Injection. Keep the leaflet for reference because it gives you a summary of important information about IMITREX Injection.

    Read the leaflet that comes with each refill of your prescription because there may be new information.

    This leaflet does not have all the information about IMITREX Injection. Ask your healthcare provider for more information or advice.

    What is IMITREX Injection?

    IMITREX Injection is a kind of medicine called a triptan. You should take it only if you have a prescription.

    IMITREX Injection is used to relieve your migraine or cluster headache. It is not used to prevent attacks or reduce the number of attacks you have. Use IMITREX Injection only to treat an actual migraine or cluster headache attack.

    The decision to use IMITREX Injection is one that you and your healthcare provider should make together, based on your personal needs and health.

    Talk with your healthcare provider before taking IMITREX Injection

    • Risk factors for heart disease to tell your healthcare provider: Tell your healthcare provider if you have risk factors for heat disease such as:
      • high blood pressure
      • high cholesterol
      • being overweight
      • diabetes
      • smoking
      • strong family history of heart disease
      • you are postmenopausal
      • you are a male over 40 years of age

        If you do have risk factors for heart disease, your healthcare provider should check you for heart disease to see if IMITREX is right for you.

        Although most of the people who have taken IMITREX have not had any serious side effects, some have had serious heart problems. Deaths have been reported, but these were rare considering the extensive worldwide use of IMITREX. Usually, serious problems happened in people with known heart disease. It was not clear whether IMITREX had anything to do with these deaths.

    • Important questions to ask yourself before you take IMITREX Injection: If the answer to any of the following questions is YES or if you do not know the answer, then please talk with your healthcare provider before you take IMITREX Injection.
      • Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate contraception? Are you breastfeeding?
      • Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?
      • Do you have risk factors for heart disease (see list above)?
      • Have you had a stroke, a mini-stroke (also called a transient ischemic attack or TIA), or Raynaud syndrome?
      • Do you have high blood pressure?
      • Have you ever had to stop taking this or any other medicine because of an allergy or other problems?
      • Are you taking any other migraine medicines, including other triptans? Are you taking any medicines containing ergotamine, dihydroergotamine, or methysergide?
      • Are you taking any medicine for depression or other health problems such as a monoamine oxidase inhibitor, selective serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI)? Common SSRIs are citalopram HBr (CELEXA®), escitalopram oxalate (LEXAPRO®), paroxetine (PAXIL®), fluoxetine (PROZAC®/SARAFEM®), olanzapine/fluoxetine (SYMBYAX®), sertraline (ZOLOFT®), and fluvoxamine. Common SNRIs are duloxetine (CYMBALTA®) and venlafaxine (EFFEXOR®).
      • Have you had, or do you have, any disease of the liver or kidney?
      • Have you had, or do you have, epilepsy or seizures?
      • Is this headache different from your usual migraine attacks?

        Remember, if you answered YES to any of the above questions, then talk with your healthcare provider about it.

    Important points about IMITREX Injection

    • The use of IMITREX Injection during pregnancy:

      Do not take IMITREX Injection if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception unless you have talked with your healthcare provider about this.

    • How to take IMITREX Injection:

      For adults, the usual dose is a single injection given just below the skin. You should give an injection as soon as the symptoms of your migraine start, but it may be given at any time during an attack. You may give a second injection if your migraine symptoms come back.

      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. Do not give more than two 6-mg doses in any 24-hour period. Allow at least 1 hour between each dose.

    • Caution for activities requiring alertness:

      You may feel drowsy or dizzy because of your migraine or treatment with IMITREX Injection. Use caution for activities requiring alertness (like driving or using machines).

    • What to do if you take an overdose:

      If you have taken more medicine than has been prescribed for you, contact either your healthcare provider, hospital emergency department, or nearest poison control center right away.

    • How to store your medicine:

      Keep your medicine in a safe place where children cannot reach it. It may be harmful to children.

      Store your medicine away from heat and light. Keep your medicine in the Carrying Case that comes with it. Do not store at temperatures above 86°F (30°C).

      The expiration date of your medicine is printed on the back of the Cartridge Pack. If your medicine has expired, throw it away. Do not throw away your IMITREX STATdose Pen®.

      If your healthcare provider decides to stop your treatment, do not keep any leftover medicine unless your healthcare provider tells you to.

    Some possible side effects of IMITREX Injection

    • Some patients feel pain or tightness in the chest or throat when using IMITREX Injection. If this happens to you, tell your healthcare provider before taking any more IMITREX Injection. If the chest pain, tightness, or pressure is severe or does not go away, call your healthcare provider right away.
    • Call your healthcare provider right away if you have sudden and/or severe abdominal pain after you take IMITREX Injection.
    • Some people may have a reaction called serotonin syndrome when they take certain kinds of medicines for depression called SSRIs or SNRIs while they are taking IMITREX Injection. Symptoms may include confusion, hallucinations, fast heartbeat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your healthcare provider right away if you have any of these symptoms after taking IMITREX Injection.
    • Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your healthcare provider right away. Do not take any more IMITREX Injection unless your healthcare provider tells you to.
    • Some people may feel tingling, heat, flushing (redness of face lasting a short time), heaviness, or pressure after taking IMITREX Injection. A few people may feel drowsy, dizzy, tired, or sick. If you have any of these symptoms, tell your healthcare provider at your next visit.
    • You may have pain or redness at the site of injection, but this usually lasts less than an hour.
    • If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your healthcare provider right away.

    IMITREX, IMITREX STATdose System, IMITREX STATdose Pen, and PAXIL are registered trademarks of GlaxoSmithKline. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    ©2010, GlaxoSmithKline. All rights reserved.

    February 2010

    IMJ:2PPI

  • Drug Information Provided by National Library of Medicine (NLM).
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