SEMGLEE and Insulin Glargine (insulin glargine-yfgn) injection: Prefilled insulin injection pen

SEMGLEE and Insulin Glargine (insulin glargine-yfgn) injection: Prefilled insulin injection pen

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THE SEMGLEE PREFILLED PEN

  • SEMGLEE and Insulin Glargine (insulin glargine-yfgn) are available as prefilled, single-patient-use, prefilled insulin injection pens that contain 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

Insulin Glargine (insulin glargine-yfgn) is the same as SEMGLEE (insulin glargine-yfgn) injection. Your pharmacist can help you determine which option is for you.

WHAT TO KNOW BEFORE USING THE PREFILLED PEN

Before you self-administer

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

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 PREFILLED PEN ASSEMBLY

prefilled_semglee

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 HOW TO USE VIDEO

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PrefillledINSTRUCTIONS FOR USE SEMGLEE® (insulin glargine-yfgn) injection Single-Patient-Use Prefilled Pen injection

Your healthcare professional has decided that SEMGLEE is right for you. Talk with your healthcare professional about proper injection technique before using SEMGLEE.

Read these instructions carefully before using your SEMGLEE. If you are not able to follow all the instructions completely on your own, use SEMGLEE only if you have help from a person who is able to follow the instructions.

People who are blind or have vision problems should not use SEMGLEE single-patient use prefilled pen without help from a person trained to use SEMGLEE single-patient-use prefilled pen.

Follow these instructions completely each time you use SEMGLEE to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SEMGLEE is a disposable pen for the injection of insulin. Each SEMGLEE contains in total 300 units of insulin. You can set doses 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.

If you have any questions about SEMGLEE, ask your healthcare professional, or call VIATRIS at 1-877-446-3679 (1-877-4-INFO-RX).

  •  Do not share your SEMGLEE 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 re-use needles. Always attach a new needle before each use.
  • BD® Ultra-Fine needles are compatible with SEMGLEE. These are sold separately and are manufactured by BD. Contact your healthcare professional for further information.
  • Always perform the safety test before each injection.
  • Do not select a dose or press the injection button without a needle attached.
  • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
  • Never use SEMGLEE if it is damaged or if you are not sure that it is working properly.
  • If recommended by your healthcare provider, carry a spare SEMGLEE in case your SEMGLEE is lost or damaged.
  • Change (rotate) your injection sites within the area you choose for each dose (see “Places to inject”).
  • Places to inject

  • Inject your insulin exactly as your healthcare professional has shown you.
  • Inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
  • Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) 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 1 Check the insulin

  1. Check the label on your SEMGLEE to make sure you have the correct insulin. SEMGLEE is blue with a purple injection button.
  2. Take off the pen cap.
  3. Check the appearance of your insulin. SEMGLEE is a clear insulin. Do not use this SEMGLEE if the insulin is cloudy, colored or has particles.
  • Step 2 Attach the needle

Do not re-use needles. Always use a new sterile needle for each injection. This helps prevent contamination and potential needle blocks.

  1. Wipe the rubber seal with alcohol.
  2. Remove the protective seal from a new needle.
  3. Line up the needle with the pen, and keep it straight as you screw it on (See Figure).
  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle (See Figure).
  • Step 3 Perform a Safety test

Always perform the safety test before each injection.
Performing the safety test ensures that you get an accurate dose by:

  •  ensuring that pen and needle work properly
  •  removing air bubbles
  1. Select a dose of 2 units by turning the white dose knob (See Figure).
  2. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it (See Figure).

  3. Hold the pen with the needle pointing upwards.
  4. Tap the cartridge so that any air bubbles rise up towards the needle.
  5. Press the purple injection button all the way in. Check if insulin comes out of the needle tip (See Figure).

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SEMGLEE may be damaged. Do not use this SEMGLEE.
  • Step 4 Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

  1. Check that the dose window shows “0” following the safety test.
  2. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

  •  Do not push the purple injection button while turning, as insulin will come out.
  • You cannot turn the white dose knob past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SEMGLEE or use a new SEMGLEE for your
    full dose.
  • Step 5 Inject the dose

  1. Use the injection method as instructed by your healthcare professional.
  2. Insert the needle into the skin (See Figure).
  3. Deliver the dose by pressing the purple injection button in all the way. The number in the dose window will return to “0” as you inject. The white dose knob will turn, and you will hear “clicks” as you press down (See Figure).
  4. Keep the purple injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
  • Step 6 Remove and discard the needle

Always remove the needle after each injection and store SEMGLEE without a needle attached.

This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin cartridge and leakage of insulin, which can cause inaccurate dosing.
  1. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
    • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g., a one-handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
  2. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly. If you are giving an injection to another person, you should remove the needle in an approved manner to avoid needle-stick injuries.
  3. Always put the pen cap back on the pen, then store the pen until your next injection.
  • Storage Instructions

  • Please check the leaflet for the insulin for complete instructions on how to store SEMGLEE.
  • If your SEMGLEE is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.
  • Keep SEMGLEE out of the reach and sight of children.
  • Keep your SEMGLEE in cool storage at 36° to 46°F (2° to 8°C) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator or next to a freezer pack.
  • Once you take your SEMGLEE out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SEMGLEE in use must not be stored in a refrigerator.
  • Do not use SEMGLEE after the expiration date printed on the label of the pen or on the carton.
  • Protect SEMGLEE from light.
  • Discard your used SEMGLEE as required by your local authorities.
  • Maintenance

  • Protect your SEMGLEE from dust and dirt.
  • You can clean the outside of your SEMGLEE by wiping it with a damp cloth.
  • Do not soak, wash, or lubricate the pen as this may damage it.
  • Your SEMGLEE is designed to work accurately and safely. It should be handled with care.
  • Avoid situations where SEMGLEE might be damaged. If you are concerned that your SEMGLEE may be damaged, use a new one.



References:

  1. SEMGLEE® (insulin glargine-yfgn) injection. Prescribing Information. 2021. Mylan Pharmaceuticals Inc. Morgantown, WV
Semglee logo

Instructions For Use

Please select from the following:

MORE LESS

IMPORTANT SAFETY INFORMATION

(This information also applies to Insulin Glargine (insulin glargine-yfgn) injection)

What is SEMGLEE® (insulin glargine-yfgn) injection 100 Units/mL?

SEMGLEE is a prescription long-acting man-made-insulin used to control high blood sugar in adults and children with type 1 diabetes and in adults with type 2 diabetes.

  • 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.

IMPORTANT SAFETY INFORMATION

(This information also applies to Insulin Glargine (insulin glargine-yfgn) injection)

What is SEMGLEE® (insulin glargine-yfgn) injection 100 Units/mL?

SEMGLEE is a prescription long-acting man-made-insulin used to control high blood sugar in adults and children with type 1 diabetes and in adults with type 2 diabetes.

  • 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.

IMPORTANT SAFETY INFORMATION

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.

Do not use SEMGLEE during episodes of low blood sugar or if you are allergic to insulin glargine or any of the ingredients in SEMGLEE.

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

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.

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-yfgn) 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.