Semglee (Prefilled Pen)

Semglee (Prefilled Pen) is a long-acting insulin that begins to work several hours after injection and continues to work steadily for 24 hours.

Semglee (Prefilled Pen) is used to help control blood sugar levels in people with diabetes mellitus.

Toujeo is for adults with type 1 or type 2 diabetes.

Basaglar, Lantus, and Semglee are for adults with type 1 or type 2 diabetes and for children who are at least 6 years old with type 1 diabetes (not type 2).

For type 1 diabetes, Semglee (Prefilled Pen) is used along with a short-acting insulin taken before meals.

Semglee (Prefilled Pen) may also be used for reasons not mentioned in this medication guide.

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

You should not use Semglee (Prefilled Pen) if you are allergic to insulin, or if you are experiencing hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

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

Tell your doctor if you have ever had:

• liver or kidney disease; or
• heart failure or other heart problems.

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes found in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while 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 this medicine if you are pregnant or become pregnant. Controlling diabetes is very important during pregnancy.

Get emergency medical help if you have signs of an insulin allergy: redness or swelling at the injection site, itchy skin rash all over your body, trouble breathing, fast heartbeats, feeling faint, or swelling of your tongue or throat.

Semglee (Prefilled Pen) may cause serious side effects. Call your doctor immediately if you experience:

• 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 feeling limp.

Common side effects of Semglee (Prefilled Pen) may include:

• low blood sugar;
• swelling, weight gain;
• allergic reaction, itching, rash; or
• thickening or hollowing of the skin at the injection site.

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 the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Semglee (Prefilled Pen) 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 (Prefilled Pen) must not be given with an insulin pump, or mixed with other insulins. Do not inject this medicine 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 (Prefilled Pen). 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.

Toujeo contains 300 units of insulin glargine per milliliter (mL), which is 3 times stronger than brands that contain 100 units per mL.

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 (Prefilled Pen). 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 this medicine 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 (Prefilled Pen):

• Refrigerate and use until expiration date; or
• (Basaglar, Lantus, or Semglee) Store at room temperature (below 86 degrees Fahrenheit) and use within 28 days.

Storing opened (in use) Semglee (Prefilled Pen):

• Store the vial in a refrigerator or at room temperature and use within 28 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 28 days.
• Store Toujeo at room temperature below 86 F (do not refrigerate) and use within 56 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.

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 help or call the Poison Help line at 1-800-222-1222. Taking too much insulin can lead to severe hypoglycemia. Symptoms may 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.

Do not drive or engage in activities that could be dangerous until you understand how Semglee (Prefilled Pen) affects you. Your reactions may be impaired.

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

Do not drink alcohol or use medicines that contain alcohol. It may interfere with your diabetes treatment.

Many drugs can change your blood sugar levels and may also impact Semglee (Prefilled Pen). This includes both prescription and over-the-counter medicines, as well as vitamins and herbal products. Inform your doctor about all other medicines you are using. Not all possible interactions are mentioned here.

Find detailed information on biosimilars for this medication.