Let's Explore SEMGLEE

Let's Explore SEMGLEE

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  • semglee once dailySEMGLEE is a once-daily, long-acting, man-made insulin used to control high blood sugar in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.1
  • semglee prefilledIt is a prefilled pen with 3-ml solution containing 100-U/ml insulin glargine.1
    Designed to be used for multiple subcutaneous injections with disposable needles.1
  • semglee treatIt is not for use in treating diabetic ketoacidosis.1
    It is not known if SEMGLEE is safe and effective in children younger than 6 years with type 1 diabetes or in children with type 2 diabetes.1
  • semglee pen
SEMGLEE Pen Instructions for use

UNDERSTANDING DIABETES

Diabetes is common in the United States.2

Among people who have been identified as having diabetes, more than 1 in 4 people are not aware that they have this condition.2

Diabetes can affect anyone: children and adults of any age.2

WHAT IS DIABETES?

Diabetes is a condition that occurs when Glucose, also called blood sugar is too high. Glucose is your main source of energy and comes from the food you eat. Insulin, a hormone made by the pancreas, is needed to transfer this glucose from your blood to your cells to be converted into energy.2

Sometimes your body doesnt make enough, or any insulin. When this happens, glucose stays in your blood without reaching your cells.2

When someone develops high blood glucose levels due to a lack of insulin, diabetes can develop.
Over time, having too much glucose in your blood can cause health problems, including heart disease, nerve damage, eye problems, and kidney disease. You can take various measures to prevent or manage diabetes.2

WHAT ARE THE DIFFERENT TYPES OF DIABETES?

Type 1 diabetes2

  • If you have type 1 diabetes, your body does not produce insulin on its own because your immune system attacks and destroys the cells in your pancreas that makes insulin
  • Type 1 diabetes is usually diagnosed during childhood or during the teenage years, although it can appear at any age
  • Having a parent or a sibling with type 1 diabetes might increase the chance of developing type1 diabetes

Type 2 diabetes2

  • If you have type 2 diabetes, your body does not make or use insulin enough to produce energy
  • You can develop type 2 diabetes at any age, even during childhood. However, this type of diabetes occurs most often in middle-aged and older adults
  • Risk factors for type 2 diabetes include a family history of diabetes or obesity

If you have been diagnosed with Type 1 or Type 2 Diabetes, talk to your doctor about the best way to manage it, including whether insulin is an appropriate option for you.2

THE IMPORTANCE OF INSULIN

Insulin is a hormone made by the pancreas that helps transfer the glucose in the food you eat from your blood to the cells in your muscles, fat, and liver, where it is used for energy.

In type 1 diabetes2:

  • The pancreas cannot or has stopped producing insulin.
  • People with type 1 diabetes need to take daily insulin shots, along with maintaining a healthy diet and regular exercise routine, to manage the disease.

In type 2 diabetes2:

  • The pancreas doesn't produce enough insulin or the body doesn't use it efficiently.
  • People with type 2 diabetes may need to manage their condition with insulin shots or other drugs, along with maintaining a healthy diet and a regular exercise routine, as directed by their doctor.

 

References:

  1. SEMGLEE® (insulin glargine injection). Prescribing Information. 2020. Mylan Pharmaceuticals Inc. Morgantown, WV.
  2. National Institute of Diabetes and Digestive and Kidney Diseases. What is Diabetes?
    Accessed June 30, 2021.
    https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes

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.