Understanding Side Effects

Common Side Effects of Victoza^®

As with most medications, Victoza^® may cause side effects. The most common side effects with Victoza^® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza^®, but decreases over time in most people. Immune system–related reactions, including hives, were more common in people treated with Victoza^®, compared to people treated with other diabetes drugs in medical studies.

Often, these side effects are dose-related and gradually decrease over time. Nausea is most common when first starting Victoza^®, yet studies show that the number of patients experiencing nausea declined with continued use. Approximately 13% of patients treated with Victoza^® reported nausea during the first 2 weeks of treatment.

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Additional Important Safety Information

Low blood sugar (hypoglycemia)

Your risk for getting low blood sugar is higher if you take Victoza^® with another medication that can cause low blood sugar, such as a sulfonylurea.

Signs and symptoms of low blood sugar may include:

Possible thyroid tumors, including cancer

During the drug testing process, the medicine in Victoza^® caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.

Before you start taking Victoza^®, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or multiple endocrine neoplasia syndrome type 2 (MEN 2). Do not take Victoza^® if you or any of your family members have medullary thyroid cancer, or if you have MEN 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Victoza^®.

While taking Victoza^®, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Before taking Victoza^®, tell your healthcare provider
if you have had:

• Pancreatitis
• Stones in your gallbladder (gallstones)
• A history of alcoholism
• High blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Victoza^®.

Pancreatitis is a serious condition that may be severe and lead to death.

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What to Tell Your Doctor

Tell your doctor if you have any of the conditions listed above. Also tell your doctor if you:

• are allergic to liraglutide or any of the other ingredients in Victoza^®. See the Medication Guide for a list of ingredients in Victoza^®.
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
• have or have had kidney or liver problems.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if Victoza^® will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Victoza^®.
• are breastfeeding or plan to breastfeed. It is not known if Victoza^® passes into your breast milk. You and your healthcare provider should decide if you will take Victoza^® or breastfeed. You should not do both without talking with your healthcare provider first.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Victoza^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Victoza^® may affect the way some medicines work and some other medicines may affect the way Victoza^® works. Tell your healthcare provider if you take other diabetes medicines, especially sulfonylurea medicines or insulin.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

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Indications and Usage

Victoza^® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.

Victoza^® is not recommended as the first medication to treat diabetes. Victoza^® is not insulin and has not been studied in combination with insulin. Victoza^® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza^® is safe and effective in children. Victoza^® is not recommended for use in children.

Important Safety Information

In animal studies, Victoza^® caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza^® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people which may be fatal if not detected and treated early. Do not use Victoza^® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza^®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Before taking Victoza^®, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis.

Stop taking Victoza^® and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.

Before using Victoza^®, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza^® may affect how each medicine works.

Also tell your doctor if you are allergic to any of the ingredients in Victoza^®; have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza^® will harm your unborn baby or if Victoza^® passes into your breast milk.

Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza^® with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza^®.

Victoza^® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.

The most common side effects with Victoza^® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza^®, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza^® compared to people treated with other diabetes drugs in medical studies.

Please click here for Prescribing Information and Medication Guide.

Novo Nordisk provides patient assistance for those who qualify.
Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.