insulin degludec and liraglutide

What is the most important information I should know about insulin degludec and liraglutide?

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

What is insulin degludec and liraglutide?

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

Liraglutide is similar to a hormone that occurs naturally in the body and 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. This medicine should be used together with diet and exercise.

Insulin degludec and liraglutide is usually given when your blood sugar levels have not been well controlled by using other medications.

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

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

What should I discuss with my healthcare provider before taking insulin degludec and liraglutide?

• 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 occur 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 you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I take insulin degludec and liraglutide?

Follow all directions 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 medication by yourself. Use only the injection pen supplied with this medicine. Do not dilute or mix other medicines in the injection with insulin degludec and liraglutide.

You may use this medicine with or without food.

Your care provider will show you the best places on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place 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.

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

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be 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.

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 disease to pass from one person to another.

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

• Refrigerate and use until 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 new medicine.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking insulin degludec and liraglutide?

What are the possible side effects of insulin degludec and liraglutide?

• severe nausea and vomiting;
• shortness of breath (even with mild exertion);
• swelling in your feet or ankles, rapid weight gain;
• signs of pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• kidney problems --little or no urination, painful or difficult urination; or
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects 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.

What other drugs will affect insulin degludec and liraglutide?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin degludec and liraglutide. 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.

Where can I get more information?

Your pharmacist can provide more information about insulin degludec and liraglutide.