Insulin degludec and liraglutide

Insulin is a hormone that helps lower glucose (sugar) levels in the blood. Insulin degludec is a long-acting insulin that begins to work several hours after injection and continues to work steadily for 24 hours.

Liraglutide is similar to a natural hormone in the body that helps control blood sugar, insulin levels, and digestion.

Insulin degludec and liraglutide is a combination medicine used to lower blood sugar in adults with type 2 diabetes mellitus. Insulin degludec and liraglutide should be used along with diet and exercise.

Insulin degludec and liraglutide is typically used when your blood sugar levels have not been well managed with other medications.

Insulin degludec and liraglutide is not for people with type 1 diabetes.

Insulin degludec and liraglutide may also be used for other purposes not mentioned in this medication guide.

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

Insulin degludec and liraglutide is injected under the skin, usually once daily at the same time each day. A healthcare provider will teach you how to properly use the medicine on your own. Use only the injection pen that comes with insulin degludec and liraglutide. Do not dilute or mix any other medicines in the injection with insulin degludec and liraglutide.

You can use this medicine with or without food.

Your healthcare provider will show you the best places on your body to inject this medicine. Use a different spot each time you give an injection. Do not inject into the same spot two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Call your doctor if you have ongoing vomiting or diarrhea. You can easily become dehydrated while using this medicine, which may lead to kidney failure.

Your blood sugar will need to be checked frequently, and you may need other blood tests at your doctor's office.

You may experience low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you experience severe hypoglycemia. Make sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or diseases to spread from one person to another.

Keep this medicine in its original container, away from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Dispose of any insulin that has been frozen.

Storing unopened (not in use) insulin degludec and liraglutide:

• Refrigerate and use until the expiration date; or
• Store at room temperature and use within 21 days (3 weeks).

Storing opened (in use) insulin degludec and liraglutide:

• Store at room temperature away from heat and light, and use within 21 days; or
• Store in a refrigerator and use within 21 days.

Do not store the injection pen with a needle attached.

Do not use the medicine if it looks cloudy or has changed colors. Call your pharmacist for a replacement.

You should not use insulin degludec and liraglutide if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or if you are having an episode of low blood sugar or diabetic ketoacidosis.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people.

Call your doctor right away if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

You should not use this medicine if you are allergic to insulin or liraglutide. Do not use this medicine during low blood sugar, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands);
• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer);
• diabetic ketoacidosis (call your doctor for treatment); or
• a condition for which you use liraglutide (Saxenda, Victoza) or a medicine like liraglutide (albiglutide, dulaglutide, exenatide, lixisenatide, Adlyxin, Byetta, Bydureon, Tanzeum, Trulicity).

Tell your doctor if you have ever had:

• pancreatitis;
• kidney or liver disease;
• stomach problems causing slow digestion;
• alcoholism;
• gallstones; or
• if you also use a meal-time insulin.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would happen in people using regular doses. Ask your doctor about your risk.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin if you are pregnant or become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications for both the mother and the baby.

Insulin degludec and liraglutide is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Insulin degludec and liraglutide may cause serious side effects. Call your doctor right away if you have:

• severe nausea and vomiting;
• shortness of breath (even with mild activity);
• swelling in your feet or ankles, rapid weight gain;
• signs of pancreatitis--severe pain in your upper stomach that spreads to your back, nausea and vomiting, fast heart rate;
• kidney problems--little or no urination, painful or hard urination; or
• low potassium level--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 insulin degludec and liraglutide may include:

• nausea, diarrhea;
• headache; or
• cold symptoms such as stuffy or runny nose, sneezing, sore throat.

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.

Usual Adult Dose for Diabetes Type 2:

Dose is directed in units of insulin degludecBasal Insulin or GLP-1 Receptor Agonist Naive: -Initial dose: 10 units subcutaneously once a day Currently Receiving a Basal Insulin or GLP-1 Receptor Agonist: Discontinue therapy with basal insulin and/or liraglutide prior to initiating: -Initial dose: 16 units subcutaneously once a day TITRATION: Adjust dose up or down in increments of 2 units every 3 to 4 days based on individual metabolic needs, blood glucose monitoring, and glycemic goal until desired fasting plasma glucose is achievedMaximum daily dose: 50 units (insulin degludec 50 units; liraglutide 1.8 mg) Comments:-Insulin degludec 1 unit and liraglutide 0.036 mg are provide per unit; a table providing the corresponding milligrams of liraglutide may be found in the manufacturer product labeling.-To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be necessary with changes in physical activity, food intake, during acute illness, or with use of concomitant medications. -This combination drug is not recommended as first-line therapy because of the uncertainty of rodent C-cell tumor finding to humans. -The combination drug has not been studied in combination with prandial insulin. Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

If you miss your dose for more than 3 days in a row, call your doctor for instructions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You should not use more than 50 units of insulin degludec and liraglutide in one day.

Do not drink alcohol. Check your other medicine labels to make sure these products do not contain alcohol.

Avoid driving or doing any dangerous activities until you know how this medicine will affect you. Your reactions could be impaired.

Many other medicines can change your blood sugar levels, and some can affect how insulin degludec and liraglutide work. Certain drugs can also reduce your symptoms of hypoglycemia, making it harder to recognize when your blood sugar is low. Inform all your health care providers about every medicine you are currently taking and any new medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.