SEMGLEE®: The Pre-filled Insulin Injection Pen

SEMGLEE®: The Pre-filled Insulin Injection Pen

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THE SEMGLEE DISPOSABLE PEN

  • SEMGLEE is a disposable, single-patient-use, pre-filled insulin injector pen that contains a total of 300 units of insulin glargine. Each pen contains multiple doses of insulin. Simply select doses from 1 to 80 units in steps of 1 unit. Please note: If your prescribed dose is more than 80 units, you might need to self-administer more than 1 injection.1

WHAT TO KNOW BEFORE USING THE SEMGLEE PEN

Before you self-administer

Read the Instructions for Use each time you self-administer SEMGLEE.

Follow the instructions at each injection

Failure to follow instructions closely may result in injecting either too much or too little insulin, which in turn could adversely affect your blood sugar level.1

Talk to your doctor

Talk to your doctor

This information does not take the place of talking to your doctor about your medical condition or your treatment. Your healthcare provider should show you and/or a caregiver the correct way of using the SEMGLEE pen before you use it for the first time.1

SEMGLEE PEN ASSEMBLY

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BEFORE PREPARING YOUR SEMGLEE DOSE

doDO
  • Wash your hands rubbing with soap and water or clean them with alcohol.1
  • Check the SEMGLEE label to make sure you are taking the right type of insulin. This is especially important if you use more than one type of insulin.1
  • Before administering, hold the pen up to light, and check to see that the insulin is clear and colorless.1
  • 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 receive an incorrect dose of insulin.1
  • Always use a new syringe or needle for each injection.1
dontDON'T
  • Don't use SEMGLEE if it is colored or cloudy or if you see particles in the solution.1
  • Don't use SEMGLEE after the expiration date stamped on the label or 28 days after you first use it.1
  • Don't reuse or share your syringes or needles with other people. You could give other people a serious infection or get a serious infection yourself.1
  • People who are blind or have vision problems should not use the SEMGLEE pre-filled pen without help from a person trained on how to use it.1

WATCH THE SEMGLEE APPLICATION VIDEO

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PrefillledSTEP-BY-STEP INSTRUCTIONS FOR USING THE SEMGLEE PEN

  • Step 1 Prepare your pen

    • After you take the pen out of the refrigerator, rest it on a flat surface, and wait for it to reach room temperature (between 59°F and 86°F) before you use it.1

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  • Step 2 Attach a new needle

    • Take the cap off the pen and screw on a fresh needle.1

      Steps Image

  • Step 3 Prime your pen needle

    • Dial up two units, point the needle upward, and tap the pen so air bubbles collect at the top. Press the purple injection button until it stops moving and the dose window shows "0," making sure insulin squirts out of the needle. This removes any air bubbles, which could affect your dose.1

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  • Step 4 Select your dose

    • Select the dose you need, as discussed with your doctor or diabetes nurse.1

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  • Step 5 Select and disinfect the injection site

    • Choose an injection site as explained to you by your doctor, nurse or pharmacist; this could include an upper outer arm, thigh, buttock, or the abdomen.1

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  • Step 6 Inject your dose

    • Push the needle straight into the skin and press the purple injection button. Hold the injection button down for 10 seconds after the dose window shows "0" to make sure all of the insulin is injected, and then pull the needle smoothly out of your skin.1

      Steps Image

  • Step 7 After your injection

    • Take the outer cap that you had saved in step 2, hold it at the widest part, and carefully cover the needle without touching it. Squeeze the wide part of the outer cap and unscrew the needle in a counterclockwise (left) direction. Keep twisting the needle until it comes off the pen. Put the needle in a sharps disposal container. Place the pen cap back on the cartridge. If there is still medicine left in your pen, store the pen at room temperature (up to 86°F).1

      Steps Image

  • Step 8 Dispose of used needles and syringes

    • Take the used needle off the pen and put it in your sharps bin. Replace the pen cap over the cartridge, store the pen at room temperature (less than 86°F), and you're done.1

References:

  1. SEMGLEE® (insulin glargine injection). Prescribing Information. 2020. Mylan Pharmaceuticals Inc. Morgantown, WV.

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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.