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APIDRA- insulin glulisine injection, solutionAPIDRA SOLOSTAR- insulin glulisine injection, solution


  1. Patient Information
  2. Who Should Not Use Apidra?do Not Use Apidra If You:
  3. Your Dose Of Apidra May Need To Change Because Of:
  4. What Should I Avoid While Using Apidra?while Using Apidra Do Not:
  5. What Are The Possible Side Effects Of Apidra?apidra May Cause Serious Side Effects That Can Lead To Death, Including:
  6. Severe Allergic Reaction (whole Body Reaction). Get Medical Help Right Away If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction:
  7. Get Emergency Medical Help If You Have:
  8. The Most Common Side Effects Of Apidra Include:
  9. Active Ingredient:
  10. Inactive Ingredients:
  11. This Instructions For Use Has Two Parts:
  12. If You Will Give Yourself Subcutaneous Injections Of Apidra:
  13. Before Every Injection Make Sure You Have The Following Items:
  14. Important Information For Use Of Apidra Solostar:
  15. How Should I Store Apidra Solostar?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share an APIDRA SoloStar Pen or Syringe or Needle between Patients

Advise patients that they must never share an APIDRA SoloStar pen with another person, even if the needle is changed. Advise patients using APIDRA vials not to reuse or share needles or syringes with another person. Sharing carries a risk for transmission of blood-borne pathogens[
APIDRA is a fast (rapid) acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

  • It is not known if APIDRA is safe or effective in children less than 4 years of age with type 1 diabetes.
  • It is not known if APIDRA is safe or effective in children with type 2 diabetes.

Who Should Not Use Apidra?do Not Use Apidra If You: 

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to insulin glulisine or any of the ingredients in APIDRA.
    • APIDRA comes in a SoloStar disposable prefilled pen or in a vial.
    • Read the detailedInstructions for Usethat come with your APIDRA.
    • Use APIDRA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much APIDRA to use and when to use it.
    • Know the amount of APIDRA you use.Do notchange the amount of APIDRA you use unless your healthcare provider tells you to.
    • Know the best time for you to take your insulin. This may change if you take a different type of insulin or if the way you give your insulin changes, for example, using an insulin pump instead of giving injections under the skin (subcutaneous injections).
    • Check your insulin label each time you give your injection to make sure you have the correct insulin. This is especially important if you also take long-acting insulin.
    • Do not reuse needles.Always use a new needle for each injection. Reuse of needles increase your risk of having blocked needles, which may cause you to get the wrong dose of APIDRA. Using a new needle for each injection lowers your risk of getting an infection.
    • Apidra is a rapid-acting insulin. Take APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
    • Apidra is injected under your skin (subcutaneously) and by continuous infusion under your skin through an insulin pump.
    • Change (rotate) injection sites within the area you chose with each dose.Do notuse the exact spot for each injection.
    • Check your blood sugar levels.Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
    Keep APIDRA and all medicines out of the reach of children.

Your Dose Of Apidra May Need To Change Because Of: 

  • a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What Should I Avoid While Using Apidra?while Using Apidra Do Not: 

  • drive or operate heavy machinery until you know how APIDRA affects you.
  • drink alcohol or use over-the-counter medicines that contain alcohol.

What Are The Possible Side Effects Of Apidra?apidra May Cause Serious Side Effects That Can Lead To Death, Including: 

  • low blood sugar (hypoglycemia).Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, trouble concentrating or confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety; irritability or mood change, hunger

Severe Allergic Reaction (whole Body Reaction). Get Medical Help Right Away If You Have Any Of These Signs Or Symptoms Of A Severe Allergic Reaction: 

  • a rash over your whole body, shortness of breath, trouble breathing, fast pulse, sweating, or feeling faint
  • low potassium in your blood (hypokalemia).
  • heart failure.Taking certain diabetes pills called TZDs (thiazolidinediones) with APIDRA may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with APIDRA. Your healthcare provider should monitor you closely while you are taking TZDs with APIDRA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
    • shortness of breath, swelling of your ankles or feet, sudden weight gain.
    Treatment with TZDs and APIDRA may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
  • Get Emergency Medical Help If You Have: 

    • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

    The Most Common Side Effects Of Apidra Include: 

    • low blood sugar (hypoglycemia), weight gain, itching, rash, swelling, allergic reactions including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy).
    These are not all the possible side effects of APIDRA.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of APIDRA.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.Do notuse APIDRA for a condition for which it was not prescribed.Do notgive APIDRA 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 APIDRA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about APIDRA that is written for health professionals.

    Active Ingredient: 

    insulin glulisine

    Inactive Ingredients: 

    metacresol, tromethamine, sodium chloride, polysorbate 20, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY
    For more information, go to www.APIDRA.com or call 1-800-633-1610.

    INSTRUCTIONS FOR USE
    APIDRA10 mL vial (100 Units/mL)

    Do not share your syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

    This Instructions For Use Has Two Parts: 


    Part 1 Use with a syringe
    Part 2 Use with an external insulin infusion pump

    Be sure to read, understand and follow these instructions before taking APIDRA.

    Part 1 Use with a syringe

    If You Will Give Yourself Subcutaneous Injections Of Apidra: 

    • You should take APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
    • Do not inject APIDRA if you are not going to eat within 15 minutes.
    • Inject APIDRA into the skin of your upper arm, thigh, or stomach area. Do not inject APIDRA into a vein or into a muscle.
    • Choose an injection area (upper arm, thigh, or stomach area). Change injection sites within the area you choose with each dose.Do not inject into the exact same spot for each injection.
    • Do not mix APIDRA with insulins other than NPH, for subcutaneous injections. If mixing APIDRA with NPH insulin, draw up APIDRA into the syringe first. Inject the mixture right away.
    • Use the needles and syringes prescribed by your healthcare provider.
    • Do not reuse or share your syringes with other people. You may give other people a serious infection, or get a serious infection from them.
    • Do not reuse needles.

    Before Every Injection Make Sure You Have The Following Items: 

    • Alcohol swabs
    • Needle and syringe
    • Insulin vial
    • Puncture resistant container.

      19.
      Check with your healthcare provider's office for instructions about the right way to dispose of used needles and syringes. There may be local or state laws about how to dispose of used needles and syringes. Do not dispose of used needles or syringes in household trash and do not recycle them.
      20.
      Put used needles and syringes in a container specially made for throwing away syringes and needles (called a "sharps" container) or a hard plastic container with a screw-on cap or a metal container with a plastic lid labeled "Used Syringes". These containers should be sealed and dispose of the right way.

      • Check with your healthcare provider or pharmacist to

        • Keep in the refrigerator or below 77 F (25 C).
        • Keep vials away from direct heat and light.
        • Dispose of any opened vial after 28 days after the first use, even if there is insulin left in the vial.

        Rev. February 2015

        sanofi-aventis U.S. LLC
        Bridgewater NJ 08807
        A SANOFI COMPANY

        2015 sanofi-aventis U.S. LLC

        APIDRASoloStar
        (insulin glulisine injection) for subcutaneous use
        3 mL SoloStar prefilled pen

        Instructions for Use

        Be sure that you read, understand, and follow these instructions before you use your APIDRA SoloStar. Talk with your healthcare provider about the right way to use your APIDRA SoloStar before you use it for the first time. Keep this leaflet in case you need to look at it again later.

        Do not share your APIDRA SoloStar pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

        People who are blind or have vision problems should not use APIDRA SoloStar prefilled pen without help from a person trained to use APIDRA SoloStar prefilled pen.

        APIDRA SoloStar is a disposable prefilled pen used to inject APIDRA. Each APIDRA SoloStar has 300 units of insulin which can be used for many doses. You can select a dose from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of insulin have been given.

        Figure

    Important Information For Use Of Apidra Solostar: 

    • Do not share your APIDRA SoloStar pen with other people, even if the needle has been changed.You may give other people a serious infection, or get a serious infection from them.
    • Do not reuse needles.Use a new needle for each injection.
    • APIDRA SoloStar may be used with pen needles from Becton Dickinson and Company, Ypsomed, and Owen Mumford. Contact your healthcare provider for further information.
    • Do a safety test before each injection (

      • Check with your healthcare provider for instructions about the right way to dispose of used needles and APIDRA SoloStar.
      • Put used needles and used empty APIDRA SoloStar in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
      • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
        • made of a heavy-duty plastic,
        • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
        • upright and stable during use,
        • leak-resistant, and
        • properly labeled to warn of hazardous waste inside the container.
      • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: https://fda.gov/safesharpsdisposal.

    How Should I Store Apidra Solostar? 

    • Do not refrigerate APIDRA SoloStar after first use.
    • Keep at room temperature below 77 F (25 C).
    • Throw away (dispose of) any opened APIDRA SoloStar 28 days after first use.

    Maintenance

    • Protect your APIDRA SoloStar from dust and dirt.
    • You can clean the outside of your APIDRA SoloStar by wiping it with a damp cloth.
    • Do not soak, wash, or lubricate the pen as this may damage it.
    • Handle your APIDRA SoloStar with care. Avoid situations where your APIDRA SoloStar might be damaged. If you are concerned that your APIDRA SoloStar may be damaged, use a new one.

    If you have any questions about APIDRA SoloStar or about diabetes, ask your healthcare provider, go to www.apidra.com, or call sanofi-aventis U.S. at 1-800-633-1610.

    sanofi-aventis U.S. LLC
    Bridgewater, NJ 08807
    A SANOFI COMPANY

    Revised: December 2018

    2018 sanofi-aventis U.S. LLC



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