Brand Name(s):

• Victoza®

IMPORTANT WARNING

Liraglutide injection may increase the risk that you will develop tumors of the thyroid gland, including medullary thyroid carcinoma (MTC; a type of thyroid cancer), which may cause death if it is not treated at an early stage. If you develop thyroid cancer, your thyroid gland may need to be surgically removed. Tell your doctor if you or anyone in your family has or has ever had thyroid cancer, medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to use liraglutide injection. If you experience any of the following symptoms, call your doctor immediately: lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to liraglutide injection.

WHY is this medicine prescribed?

Liraglutide injection is used with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications did not control levels well enough. Liraglutide injection is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Liraglutide injection is in a class of medications called glucagon-like peptide-1 (GLP-1) receptor agonists. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Liraglutide injection also slows the emptying of the stomach and may decrease appetite and cause weight loss.

HOW should this medicine be used?

Liraglutide injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin) in your stomach, thigh, or upper arm. It is usually injected once a day with or without food. Use liraglutide injection at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use liraglutide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of liraglutide injection and increase your dose after one week.

Liraglutide injection controls diabetes but does not cure it. Continue to use liraglutide injection even if you feel well. Do not stop using liraglutide injection without talking to your doctor.

You will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Be sure to read and understand the manufacturer's instructions for injecting liraglutide using the pen. Also make sure you know how and when to set up a new pen, and what to do if you drop your pen. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully.

Always look at your liraglutide solution before you inject it. It should be clear, colorless, and free of particles. Do not use liraglutide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.

Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Throw away needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using liraglutide injection,

• tell your doctor and pharmacist if you are allergic to liraglutide, any other medications, or any of the ingredients in liraglutide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It is especially important to tell your doctor about all the medications you take by mouth because liraglutide may change the way your body absorbs these medications. Also be sure to mention insulin or oral medications for diabetes especially sulfonylureas, including chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl, in Duetact), glipizide (Glucotrol, in Metaglip), glyburide (DiaBeta, in Glucovance, Glycron, Glynase, Micronase), tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had pancreatitis (inflammation of the pancreas); severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine) or problems digesting food; a high level of triglycerides (fats) in the blood; gallstones (solid deposits that form in the gallbladder); or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using liraglutide injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using liraglutide injection.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of liraglutide you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in and out of reach of children. Store it away from light and heat. Store unused liraglutide pens in the refrigerator (36°F to 46°F [2°C to 8°C]), but do not place them near the refrigerator cooling element. Once a liraglutide pen is in use, store it at room temperature (59°F to 86°F [15°C to 30°C]) or in the refrigerator. Do not freeze. Do not use liraglutide if it has been frozen or exposed to temperatures above 86°F (30°C). Keep the cap on the liraglutide pen when it is not in use.

When traveling, be sure to keep liraglutide pens dry and at a temperature between 59°F to 86°F (15°C to 30°C).

Make a note of the date you first use a liraglutide pen, and throw away the pen after 30 days, even if there is some solution left in the pen. Throw away any liraglutide pens that are outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• severe nausea
• severe vomiting

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to liraglutide injection. Your doctor will also tell you how to check your response to liraglutide injection by measuring your blood sugar levels at home. Follow these directions carefully.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using liraglutide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 1, 2011.