GLP-1: Victoza® (liraglutide) injection 1.2 mg or 1.8 mg: Important Safety Information
Victoza®


Please scroll down for Important Safety Information and Prescribing Information.

Victoza® is a non-insulin medicine that—along with diet and exercise—can help control type 2 diabetes. Victoza® starts to lower blood sugar in as soon as 2 weeks, lowers A1C, and has been shown to keep it down in a 2-year medical study. It comes in a prefilled pen you use just once a day, any time, so it fits into your busy life. Victoza® is not for weight loss, but it may help you lose some weight. In clinical studies ranging from 26 to 52 weeks in length, many people lost some weight. In our largest study, when Victoza® was added to metformin, people lost on average up to 6.2 pounds. While many people in clinical trials lost weight, some did gain weight. Victoza® is covered by most major health care plans and if eligible, you can pay no more than $25 on your prescription co-pay.

Ask your doctor if Victoza® is right for you and visit www.victoza.com.

What is Victoza®?

Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.

  • Victoza® is not recommended as the first choice of medicine for treating diabetes.
  • It is not known if Victoza® can be used in people who have had pancreatitis.
  • Victoza® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
  • It is not known if Victoza® can be used with mealtime insulin.
  • It is not known if Victoza® is safe and effective for use in children.

 

Important Safety Information

What is the most important information I should know about Victoza®?
Victoza® may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your health care 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. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza®?
Do not use Victoza® if:

  • you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • you are allergic to liraglutide or any of the ingredients in Victoza®.

What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:

  • have or have had problems with your pancreas, kidneys, or liver.
  • have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza®?

  • Do not mix insulin and Victoza® together in the same injection.
  • You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
  • Do not share your Victoza® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
  • kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
  • serious allergic reactions. Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.

The most common side effects of Victoza® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.

See Victoza® Prescribing Information.

 

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.