Indications and Usage
Victoza® (liraglutide [rDNA origin] injection) 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® has not been studied in patients with history of inflammation of the pancreas (pancreatitis). Victoza® is not a substitute for insulin and has not been studied in combination with prandial (mealtime) 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.
Do not use Victoza® if you are allergic to liraglutide or any of the ingredients in Victoza®. Serious allergic reactions can happen with Victoza®. If symptoms of serious allergic reactions occur, stop taking Victoza® and seek medical attention. 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. If you use Victoza® with insulin, you may give both injections in the same body area (for example, your stomach area), but not right next to each other.
Also tell your doctor if you 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; or 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 or insulin. The dose of your sulfonylurea medicine or insulin 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.
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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.