Semglee is a man-made form of a hormone (insulin) that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Semglee is used to improve blood sugar control in patients with diabetes mellitus.

Semglee is for use in adults with type 1 or 2 diabetes and in children at least 6 years old with type 1 diabetes (not type 2).

• 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.

For type 1 diabetes, Semglee is used together with a short-acting insulin given before meals.

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.

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 page for a complete list of ingredients.

Never share an injection pen, even if you changed the needle.

Use Semglee exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Semglee is injected under the skin, usually once per day at the same time of day.

When treating type 1 diabetes, use your short-acting insulin before meals as directed by your doctor.

Semglee must not be given with an insulin pump, or mixed with other insulins. Do not inject Semglee into a vein or a muscle.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject Semglee. Do not inject into the same place two times in a row.

Avoid injecting into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

If you use an injection pen, use only the injection pen that comes with Semglee. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen, even if you changed the needle. Sharing these devices can pass infections from person to person.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Keep Semglee in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Semglee:

• Refrigerate and use until expiration date; or

• Store at room temperature (below 86 degrees Fahrenheit) and use within 28 days.

Storing opened (in use) Semglee:

• Store the Semglee vial in a refrigerator or at room temperature and use within 28 days.

• Store the Semglee injection pen at room temperature (do not refrigerate) and use within 28 days.

Do not store an injection pen with the needle attached. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Wear a medical alert tag or carry an ID card to let others know you have diabetes.

You should not use Semglee if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Semglee is not approved for use by anyone younger than 6 years old, and some brands are for use only in adults. Do not use Semglee to treat type 2 diabetes in a child of any age.

To make sure Semglee is safe for you, tell your doctor if you have:

• liver or kidney disease; or

• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Semglee if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Call your doctor for instructions if you miss a dose. Do not use more than one dose in a 24-hour period unless your doctor tells you to.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause severe hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol or using medicines that contain alcohol. It may interfere with your diabetes treatment.

Get emergency medical help if you have any signs of an allergic reaction to Semglee: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• rapid weight gain, swelling in your feet or ankles;

• shortness of breath; or

• low blood potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Semglee side effects may include:

• low blood sugar;

• swelling, weight gain;

• allergic reaction, itching, rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can affect your blood sugar and may also affect Semglee. Some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. Not all possible interactions are listed here.