insulin degludec and liraglutide

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Pronunciation: IN su lin de GLOO dek and LIR a GLOO tide

Brand: Xultophy

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

You should not use this medicine 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 at once 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.

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?

You should not use this medicine if you are allergic to insulin or liraglutide. Do not use this medicine during an episode of 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).

To make sure insulin degludec and liraglutide is safe for you, tell your doctor if you have:

  • a history of pancreatitis;
  • kidney or liver disease;
  • stomach problems causing slow digestion;
  • a history of alcoholism;
  • a history of 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.

Follow your doctor's instructions about using this medicine if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

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

How should I take insulin degludec and liraglutide?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin degludec and liraglutide is injected under the skin once daily. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Use only the injection pen supplied with this medicine. Do not dilute or mix other medicines in the injection with insulin degludec and liraglutide.

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.

You may use this medicine with or without food, but use it the same time each day. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

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

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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 disease to pass from one person to another.

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) 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 wait until your next scheduled dose to use the medicine. Do not use extra medicine to make up the missed dose.

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

What happens if I overdose?

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

What should I avoid while taking insulin degludec and liraglutide?

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

Insulin degludec and liraglutide may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

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

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

Call your doctor at once if you have:

  • 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 --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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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