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Semglee

Generic name: insulin glargine

What is Semglee?

Semglee is a long-acting man-made insulin used to control high blood sugar in adults with diabetes mellitus.

  • Semglee is not for use 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.

What is the most important information I should know about Semglee?

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.

Who should not take Semglee?

Do not use Semglee if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to insulin glargine or any of the ingredients in Semglee. See the end of this Patient Information guide for a complete list of ingredients in Semglee.

What should I tell my healthcare provider before taking Semglee?

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.

How should I take Semglee?

  • Read the detailed instructions for use that come with your Semglee insulin.
  • Use Semglee exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Semglee to use and when to use it.
  • Know the amount of Semglee you use. Do not change the amount of Semglee you use unless your healthcare provider tells you to.
  • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Semglee. Using a new needle for each injection lowers your risk of getting an infection.
  • You may take Semglee at any time during the day but you must take it at the same time every day.
  • Only use Semglee that is clear and colorless. Do not use Semglee if it is cloudy or slightly colored, or if you see particles in the solution.
  • Semglee is injected under the skin (subcutaneously) of your thigh, buttocks, upper arms, or stomach area (abdomen).
  • Do not use Semglee in an insulin pump or inject Semglee into your vein (intravenously).
  • Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
    • Do not use the exact spot for each injection.
    • 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.
  • Do not mix Semglee with any other type of insulin or liquid medicine.
  • 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 Semglee and all medicines out of the reach of children.

Your dose of Semglee 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 the medicines you take.

What should I avoid while taking Semglee?

While using Semglee do not:

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

What are the possible side effects of Semglee?

Semglee 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, 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, trouble breathing, a fast heartbeat, or sweating.
  • low potassium in your blood (hypokalemia).
  • heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Semglee 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 Semglee. Your healthcare provider should monitor you closely while you are taking TZDs with Semglee. 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 Semglee 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 Semglee include:

  • low blood sugar (hypoglycemia), weight gain, allergic reactions, injection site reactions, skin thickening or pits at the injection site (lipodystrophy), itching, rash and swelling.

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.

General information about the safe and effective use of Semglee

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Semglee for a condition for which it was not prescribed. Do not give Semglee to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Semglee that is written for health professionals.

How should I store Semglee?

Do not store Semglee in the freezer and do not allow to freeze. Discard Semglee if it has been frozen. Protect Semglee from direct heat and light.

Storage conditions are summarized in the following table:

Not in-use (unopened)
Refrigerated
(2° to 8°C [36° to 46°F])
Not in-use (unopened)
Room Temperature
(up to 30°C [86°F])
In-use (opened)
(see temperature below)
10 mL multiple-dose vial Until expiration date 28 days 28 days
Refrigerated (2° to 8°C [36° to 46°F])
or room temperature (up to 30°C [86°F])
3 mL single-patient-use prefilled pen Until expiration date 28 days 28 days
Room temperature (up to 30°C [86°F]) only
(Do not refrigerate)

What are the ingredients in Semglee?

  • Active ingredient: insulin glargine
  • 10 mL vial inactive ingredients: zinc, glycerol 85%, polysorbate-20, m-Cresol, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

Instructions for use

Semglee (Sehm-GLEE)
(insulin glargine injection) for subcutaneous use
10 mL Vial (100 Units/mL, U-100)

Read this Instructions for Use before you start taking Semglee and each time you get a new Semglee vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you or a caregiver how to use Semglee the right way before you use it for the first time.

Do not share your Semglee 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.

Supplies needed to give your injection:

Preparing your Semglee dose:

  • Wash your hands with soap and water or with alcohol.
  • Check the Semglee label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Check the insulin to make sure it is clear and colorless. 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.
  • Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of insulin.
  • Always use a new syringe or needle for each injection. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Step 1: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.

Step 1: If you are using a new vial, remove the protective cap. Do not remove the rubber stopper. image

Step 2: Wipe the top of the vial with an alcohol wipe. You do not have to shake the vial of Semglee before use.

Step 2: Wipe the top of the vial with an alcohol wipe. You do not have to shake the vial of Semglee before use. image

Step 3: Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

Step 3:  Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

Step 4: Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in 1 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.

Step 4:  Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in 1 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.

Step 5: Before you take 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.

Step 5:  Before you take 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.

Step 6: Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Giving your Semglee injection:

  • Inject your insulin exactly as your healthcare provider has shown you.
  • Inject your insulin under the skin (subcutaneously) of your thigh, buttocks, upper arms, or stomach area (abdomen).
  • Change (rotate) your injection site within the area you choose for each dose to reduce your 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.

Step 7: Choose your injection site. Wipe the skin with an alcohol wipe to clean the injection site. Let the injection site dry before you inject your dose.

Step 7:  Choose your injection site. Wipe the skin with an alcohol wipe to clean the injection site. Let the injection site dry before you inject your dose.

Step 8:

  • Pinch the skin.
  • Insert the needle in the way your healthcare provider showed you.
  • Release the skin.
  • Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin.
  • Leave the needle in the skin for about 10 seconds.

Step 8: pinch skin, inject needle, release skin, slowly push plunger and leave needle in skin for 10 seconds.

Step 9:

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

Disposing of used needles and syringes:

  • Put your used needles and syringes 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 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: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store Semglee?

  • Store unused Semglee vials in the refrigerator between 36° to 46°F (2° to 8°C) until the expiration date. If your 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 you are using 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.

Source: National Library of Medicine. Last updated June 8, 2020.