Semglee

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

Description

SEMGLEE contains insulin glargine as a sterile solution for subcutaneous use. Insulin glargine is a recombinant human long-acting insulin analog . SEMGLEE is produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris, as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Insulin glargine has the following structural formula:

SEMGLEE consists of insulin glargine dissolved in a clear, colorless, sterile solution. Each milliliter contains 100 units (3.64 mg) insulin glargine.

The 10 mL SEMGLEE vial contains the following inactive ingredients per mL: 30 mcg zinc, 20 mg glycerol 85%, 20 mcg polysorbate-20, 2.7 mg m-Cresol and water for injection.

The 3 mL SEMGLEE prefilled pen contains the following inactive ingredients per mL: 30 mcg zinc, 20 mg glycerol 85%, 2.7 mg m-Cresol and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. SEMGLEE has a pH of approximately 4.

Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis.

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

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.

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 products or any of the ingredients in Semglee. See the end of this Patient Information leaflet 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 single-patient-use prefilled pen.
• 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.
• Semglee comes in a single-patient-use prefilled pen that you must use to give your Semglee. The dose counter on your pen shows your dose of Semglee. Do not make any dose changes unless your healthcare provider tells you to.
• Do not use a syringe to remove Semglee from your disposable prefilled pen.
• 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. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.
• You may take Semglee at any time during the day but you must take it at the same time every day.
• Semglee is injected under the skin (subcutaneously) of your upper legs (thighs), 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 area you chose with 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 use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where 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, including reactions at your injection site; skin thickening or pits at the injection site (lipodystrophy).

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.

This Patient Information leaflet summarizes the most important information about Semglee. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Semglee that is written for healthcare professionals.

How should I store Semglee?

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.

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:

What are the ingredients in Semglee?

Active ingredient: insulin glargine-yfgn

Inactive ingredients:

• 3 mL prefilled pen: glycerol, metacresol, zinc chloride and Water for Injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.
• 10 mL vial: glycerol, metacresol, polysorbate-20, zinc chloride, 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-yfgn) injection for subcutaneous use

• Single patient use prefilled pen
• 10 ml Vial

Single-Patient-Use Prefilled Pen

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.

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.

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.

Keep this leaflet for future reference.

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

Important information for use of Semglee:

• 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.
• Always have 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

A. Check the label on your Semglee to make sure you have the correct insulin. Semglee is blue with a purple injection button.

B. Take off the pen cap.

C. 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.

A. Wipe the rubber seal with alcohol.

B. Remove the protective seal from a new needle.

C. Line up the needle with the pen, and keep it straight as you screw it on (See Figure a).

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

A. Select a dose of 2 units by turning the white dose knob (See Figure c).

B. 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 d).

C. Hold the pen with the needle pointing upwards.

D. Tap the cartridge so that any air bubbles rise up towards the needle.

E. Press the purple injection button all the way in. Check if insulin comes out of the needle tip (See Figure e).

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

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.

A. Check that the dose window shows “0” following the safety test.

B. Select your required dose (in the example below, the selected dose is 30 units, see Figure f). 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

A. Use the injection method as instructed by your healthcare professional.

B. Insert the needle into the skin (See Figure g).

C. 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 h).

D. 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.

A. 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.

B. 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.

C. 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.

10 mL Vial (100 Units/mL, U-100)

Read the 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.

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:

• a Semglee 10 mL vial
• a U-100 insulin syringe and needle
• 2 alcohol swabs
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

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 U100 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 2: Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of Semglee before use.

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 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.

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 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 the 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 7: Choosing your injection site: Semglee is injected under the skin (subcutaneously) of your upper arm, thigh, or stomach area (abdomen). Wipe the skin with an alcohol swab 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 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 at 36° to 46°F (2° to 8°C).
• Store in-use (opened) Semglee vials in a refrigerator or at room temperature up to 86°F (30°C).
• Do not freeze Semglee.
• Keep Semglee out of direct heat and light.
• If a vial has been frozen or overheated, throw it away.
• The Semglee vials you are using should be thrown away after 28 days, even if it still has insulin left in it.

Label

PRINCIPAL DISPLAY PANEL – 3 ML

• NDC 49502-196-75
  Rx only
• Semglee™
  insulin glargine injection
• For Single Patient Use Only
• 100 units/mL (U-100)
• For subcutaneous injection only
• Dispense in this sealed carton
• Solution for injection in a disposable insulin delivery device
• Do not mix with other insulins
• Use only if solution is clear and colorless with no particles visible
• *Needles not included (see top panel)
• Five 3 mL Prefilled Pens
• Each mL of prefilled pen contains 100 U (3.64 mg) insulin glargine, 30 mcg zinc, 20 mg glycerol 85%, 2.7 mg m-Cresol and water for injection. pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide.
• Recommended dosage: see Prescribing Information. As with any drug, if you are pregnant or nursing a baby, seek professional advice when using this product. Any change of insulin should be made cautiously and only under medical supervision.
• Unopened: Unopened SEMGLEE devices should be stored in a refrigerator, 36° to 46°F (2° to 8°C). Do not freeze. Discard if frozen. Discard after the expiration date.
• Open (In-Use): The opened (in-use) SEMGLEE should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SEMGLEE device must be discarded 28 days after being opened.
• WARNING: Keep this and all medication out of the reach of children.
• Discard unused portion of the
  pen 28 days after first opening.
• *BD Ultra-Fine™ needles are compatible with Semglee™. These are sold separately and manufactured by BD.
• BD Ultra-Fine™ is a trademark of Becton, Dickinson, and Company.
• Semglee™ is a trademark of Mylan Pharmaceuticals, Inc.
• Copyright © 2019 Mylan Inc. All rights reserved.
• Manufactured in Malaysia for:
  Mylan Specialty L.P.
  Morgantown, WV 26505 U.S.A.
• MA:B:196:5C:R4
• Mylan.com

PRINCIPAL DISPLAY PANEL – 10 ML

 

• NDC 49502-195-80     Rx only
• Semglee™
  insulin glargine injection
  100 units/mL (U-100)
• Do not mix with other insulins
• Use only if solution is clear and colorless with
  no particles visible
• For subcutaneous injection only
• Use with U-100 syringe only
• One 10 mL
  Multiple-Dose
  Vial
• Unopened Vial:
  Unopened Semglee™ vials
  should be stored in a refrigerator,
  36° to 46°F (2° to 8°C). Do not
  freeze. Discard vial if frozen.
  Discard after the expiration date.
• Open (In-Use) Vial:
  Vials must be discarded 28 days
  after being opened. If
  refrigeration is not possible, the
  open vial can be kept
  unrefrigerated for up to 28 days
  away from direct heat and light,
  as long as the temperature is not
  greater than 86°F (30°C).
• Semglee™ is a trademark of Mylan
  Pharmaceuticals, Inc.
• Copyright © 2019 Mylan Inc. All rights reserved.
• MA:B:19510:1C:R6
• Each mL of Semglee™ contains
  100 Units (3.64 mg) insulin glargine,
  30 mcg zinc, 20 mg glycerol 85%,
  20 mcg polysorbate-20, 2.7 mg
  m-Cresol and water for injection.
  pH is adjusted by addition of
  aqueous solutions of hydrochloric
  acid and sodium hydroxide.
• Recommended dosage: see
  Prescribing Information. As with any
  drug, if you are pregnant or nursing
  a baby, seek professional advice
  when using this product. Any change
  of insulin should be made cautiously
  and only under medical supervision.
• WARNING: Keep this and all
  medication out of the reach of
  children.
• Manufactured in Malaysia for:
  Mylan Specialty L.P.
  Morgantown, WV 26505 U.S.A.
• Mylan.com

SRC: NLM .