Victoza® Important Safety Information | WW USA

Important Victoza® Safety Information

Most Important Safety Information

  • In rats and mice, liraglutide 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. Tell your 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.
  • Do not use Victoza if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Victoza?

Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist that is used:

  • As an adjunct to diet and exercise to improve glycemic control in people with type 2 diabetes.
  • To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

Limitations of Use:

  • Victoza should not be used to treat type 1 diabetes.
  • Victoza should not be coadministered with other liraglutide-containing products.

What should I tell my provider before using Victoza?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Tell your provider if you are taking medicines to treat diabetes including insulin which could increase your risk of low blood sugar. Tell your provider if you are taking other GLP-1 receptor agonists.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • Severe problems with your stomach, such as slowed emptying of your stomach or problems with digesting food
  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Gastrointestinal disease
  • Pancreatitis
  • Kidney disease
  • Liver disease
  • Depression
  • Suicidal thoughts or behavior

Whether you are pregnant or breastfeeding.

  • If you are pregnant: Victoza should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Victoza during pregnancy.
  • If you are breastfeeding: It is not known if Victoza passes into breast milk. Talk to your provider first about the benefits and risks of using Victoza while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Insulin
  • Sulfonylureas (these can cause blood sugar levels to drop dangerously low when combined with Victoza)
  • Other GLP-1 receptor agonist medications such as liraglutide, dulaglutide, or semaglutide.
  • Other products for weight loss, including dietary supplements
  • Other oral medications: Victoza causes a delay in gastric emptying, so it can impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on managing other medications.

What are the most serious side effects that I or a caregiver should monitor for when taking Victoza?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Victoza. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • C-Cell Thyroid Tumors: In rats and mice, liraglutide caused C-Cell thyroid tumors, including thyroid cancer. It is not known if Victoza will cause C-Cell thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your 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. Do not use Victoza if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Acute Kidney Injury: Use of Victoza has been associated with gastrointestinal side effects, sometimes severe, which can lead to dehydration. If severe, dehydration could cause acute kidney injury. It is important for you to drink plenty of water to help reduce your chance of dehydration.
  • Acute Gallbladder Disease: Victoza and other GLP-1 receptor agonists are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
  • Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
  • Allergic Reactions: Stop using Victoza right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
  • Low Blood Sugar (Hypoglycemia): Victoza lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Never Share a Pen: Pen-sharing poses a risk of infection.

These common side effects can occur with Victoza.

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation

You are encouraged to report negative side effects of prescription products:

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Victoza® is a registered trademark of Novo Nordisk.