SEMGLEE® Insulin Vial

SEMGLEE® Insulin Vial

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Subject to eligibility requirements. Please see full terms and conditions.

THE SEMGLEE INSULIN INJECTION

SEMGLEE is also available in a 10-mL vial (100 U/mL, U-100).

    Supplies needed to give the injection:

  • A SEMGLEE 10-mL vial
  • A U-100 insulin syringe and needle. Needles are sold separately
  • Alcohol wipes
  • 1 sharps disposal container for throwing away used needles and syringes

Learn more on disposing of used needles and syringes

BEFORE PREPARING YOUR SEMGLEE DOSE

doDO
  • Wash your hands with soap and water or clean them with rubbing alcohol.
  • Check the SEMGLEE label to make sure you are administering the right type of insulin. This is especially important if you are administering more than one type of insulin.
  • Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you could be administering an incorrect dose.
  • Always use a new syringe or needle for each injection.
dontDON'T
  • Do not use SEMGLEE if it is colored or cloudy or if you see particles in the solution.
  • Do not use SEMGLEE after the expiration date stamped on the label or 28 days after you first use it.
  • Do not reuse syringes.
  • Do not share syringes with other people, even if the needle has been changed. You could give other people a serious infection or get a serious infection yourself.

PrefillledSTEP-BY-STEP INSTRUCTIONS FOR USING THE SEMGLEE INJECTION AND VIAL

  • Step 1

    • If using a new vial, remove the protective cap. Do not remove the rubber stopper.

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  • Step 2

    • Wipe the top of the vial with an alcohol wipe. Do not shake the vial before use.

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  • Step 3

    • Draw air into the syringe equal to the insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

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  • Step 4

    • Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe.

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  • Step 5

    • Before taking the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose.

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  • Step 6

    • Remove the needle from the vial. Do not let the needle touch anything.

      Administer the SEMGLEE injection:

      • Inject insulin exactly as healthcare provider has discussed with you.
      • Inject insulin under the skin (subcutaneously) of thigh, buttocks, upper arms, or stomach area (abdomen).
      • Change (rotate) injection site within the area chosen for each dose to reduce risk of getting pits in the skin or thickened skin (lipodystrophy), and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
      • Do not inject where the skin has pits, is thickened, or has lumps.
      • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

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  • Step 7

    • Choose injection site. Wipe the skin with an alcohol wipe to clean the injection site. Let the injection site dry before injecting dose.

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  • Step 8

      While injecting, remember to:

    1. Pinch the skin.
    2. Release the skin.
    3. Slowly push in the plunger of the syringe all the way, making sure all the insulin has been injected.
    4. Leave the needle in the skin for about 10 seconds.
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  • Step 9

    • Pull the needle straight out of skin. Gently press the injection site for several seconds. Do not rub the area. Do not recap the used needle since it can lead to a needlestick injury.

DISPOSING OF USED NEEDLES AND SYRINGES

  • Put your used needles and syringes in an 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 an FDA-cleared sharps 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 the sharps disposal container is almost full, follow your community guidelines for the correct disposal of your sharps container. There may be state or local laws about how to throw away used needles and syringes.
  • Do not dispose of a sharps container in a household trash unless community guidelines permit this. Do not recycle your used sharps disposal container.
  • 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:
    http://www.fda.gov/safesharpsdisposal.

SEMGLEE STORAGE

  • Store unused SEMGLEE vials in the refrigerator between 36° and 46°F (2° to 8°C) until the expiration date. If the unopened SEMGLEE vial is stored at room temperature, up to 86°F (30°C), it should be thrown away after 28 days.
  • Store in-use (opened) SEMGLEE vials in a refrigerator or at room temperature up to 86°F (30°C).
  • The SEMGLEE vials should be thrown away after 28 days, even if it still has insulin left in it.
  • Do not freeze SEMGLEE.
  • Keep SEMGLEE out of direct heat and light.
  • If a vial has been frozen or overheated, throw it away.

MORE LESS

IMPORTANT SAFETY INFORMATION

SEMGLEE (insulin glargine injection) 100 Units/mL is a prescription long-acting man-made-insulin used to treat adults with type 2 diabetes and adult and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

  • Do not use SEMGLEE to treat diabetic ketoacidosis.

It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes. It is not known if SEMGLEE is safe and effective in children with type 2 diabetes.

IMPORTANT SAFETY INFORMATION

SEMGLEE (insulin glargine injection) 100 Units/mL is a prescription long-acting man-made-insulin used to treat adults with type 2 diabetes and adult and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

  • Do not use SEMGLEE to treat diabetic ketoacidosis.

It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes. It is not known if SEMGLEE is safe and effective in children with type 2 diabetes.

Do not use SEMGLEE during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients of SEMGLEE. See the end of this Patient Information leaflet for a complete list of ingredients in SEMGLEE.

Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.

Do not share your 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.

Before using SEMGLEE, tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems.
  • take other medicines, especially ones called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with SEMGLEE.
  • are pregnant, planning to become pregnant, or are breastfeeding. It is not known if SEMGLEE may harm your unborn baby or breastfeeding baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before you start using SEMGLEE, talk to your healthcare provider about low blood sugar and how to manage it.

Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pitted or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.  Tell your doctor if you have any new or worsening symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, sudden weight gain.

SEMGLEE should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as SEMGLEE. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix SEMGLEE with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. SEMGLEE must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.

While using SEMGLEE, do not drive or operate heavy machinery until you know how SEMGLEE affects you. You should not drink alcohol or use other medicines that contain alcohol.

The most common side effect of insulin, including SEMGLEE, is low blood sugar (hypoglycemia), which may be serious and life threatening. It may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

SEMGLEE may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have: A rash over your whole body, trouble breathing, a fast heartbeat, sweating, swelling of your face, tongue, or throat, shortness of breath, extreme drowsiness, dizziness, or confusion.

Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.

Important Safety Information for SEMGLEE (insulin glargine injection) pen.

SEMGLEE pen is a disposable single-patient-use prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

These are not all the possible side effects of SEMGLEE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This summary does not include all the information about SEMGLEE and is not meant to take the place of a discussion with your healthcare provider about your treatment.