Victoza

Type 2 Diabetes Management

Victoza is used along with diet and exercise to improve blood sugar control in adults and children 10 years of age and older with type 2 diabetes mellitus.

Cardiovascular Risk Reduction

In adults with type 2 diabetes and established heart disease, Victoza is used to reduce the risk of major adverse cardiovascular events, such as:

• Heart attack
• Stroke
• Death from cardiovascular causes

Limitations of Use

Victoza is not a substitute for insulin and should not be used to treat type 1 diabetes or diabetic ketoacidosis. It is also not known if Victoza is safe or effective for people who have had pancreatitis in the past.

How Victoza Regulates Blood Sugar

Victoza belongs to a class of medications called GLP-1 receptor agonists. It works by acting like a hormone naturally found in the body called glucagon-like peptide-1 (GLP-1). This hormone plays several key roles in managing blood sugar levels in people with type 2 diabetes.

Stimulating Insulin Production

When blood sugar levels rise, such as after a meal, Victoza signals the pancreas to release the appropriate amount of insulin. Insulin is the hormone responsible for moving sugar from the bloodstream into the body's cells to be used for energy. Victoza only stimulates insulin release when blood sugar is high, which helps reduce the risk of blood sugar dropping too low.

Slowing Digestion

Victoza slows down the speed at which food leaves the stomach, a process known as gastric emptying. By slowing this process, the medication helps prevent blood sugar levels from spiking too quickly after eating.

Reducing Sugar Production

The medication also helps prevent the liver from making too much sugar. By reducing the amount of extra sugar released into the bloodstream, it helps maintain more stable glucose levels throughout the day.

Cardiovascular Protection

In addition to managing blood sugar, Victoza has been shown to reduce the risk of major cardiovascular events, such as heart attack or stroke, in adults with type 2 diabetes who also have established heart disease. It does this by helping to protect the heart and blood vessels over time.

Common Side Effects

The most frequent side effects reported by people using Victoza include:

• Nausea and vomiting
• Diarrhea or constipation
• Headache
• Decreased appetite or indigestion
• Redness, itching, or swelling at the injection site
• Tiredness or fatigue

Nausea is most common when first starting the medication or when the dose is increased. This symptom often decreases as the body adjusts to the medicine.

Serious Side Effects

While less common, Victoza can cause serious health issues. Seek medical attention immediately if you experience:

• Pancreatitis: Severe pain in the upper stomach area that may spread to the back, which may occur with or without vomiting.
• Gallbladder problems: Pain in the upper right stomach, fever, or yellowing of the skin or eyes (jaundice).
• Kidney issues: Changes in urination or swelling in the legs and feet. This is often caused by dehydration resulting from severe nausea, vomiting, or diarrhea.
• Low blood sugar (hypoglycemia): Symptoms include dizziness, sweating, confusion, shakiness, and blurred vision. This risk is higher if Victoza is used with other diabetes medications like insulin or sulfonylureas.
• Severe allergic reactions: Swelling of the face, lips, or tongue; difficulty breathing or swallowing; or a severe rash and fainting.
• Increased heart rate: A racing or pounding feeling in the chest that lasts for several minutes while you are at rest.

Thyroid Tumor Risk

Victoza has a boxed warning because it caused thyroid tumors in animal studies. It is unknown if it causes these tumors in humans. This medication should not be used by people with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Pancreatitis

Inflammation of the pancreas (pancreatitis) has been reported. Symptoms include severe abdominal pain that may spread to the back, with or without vomiting. If pancreatitis is suspected, the medication should be stopped immediately.

Kidney and Gallbladder Issues

• Kidney function: Some patients have experienced kidney failure or worsening of existing kidney problems, often related to dehydration from nausea or vomiting.
• Gallbladder disease: Problems such as gallstones or gallbladder inflammation may occur.

Low Blood Sugar (Hypoglycemia)

The risk of low blood sugar increases when Victoza is used with other diabetes medications like sulfonylureas or insulin. Dose adjustments of those medications may be necessary.

Allergic Reactions

Serious allergic reactions, including swelling of the face or throat and difficulty breathing, require immediate medical attention.

Heart Rate

An increase in resting heart rate can occur while using this medication. Healthcare providers may monitor heart rate during treatment.

Pregnancy

There is limited data on the use of Victoza in pregnant women. Animal studies have shown that liraglutide may cause harm to a developing fetus, including bone malformations and lower birth weight, when administered at doses higher than the human dose. Due to these risks, Victoza is typically only used during pregnancy if the potential benefit to the mother outweighs the potential risk to the baby.

Managing blood glucose levels is critical during pregnancy, as uncontrolled diabetes can lead to complications for both the mother and the infant. If you become pregnant while taking Victoza, or if you are planning to become pregnant, consult your healthcare provider to discuss the risks and benefits of continuing the medication versus switching to other treatments like insulin.

Breastfeeding

It is currently unknown if Victoza passes into human breast milk. Research in animals has shown that the drug is present in the milk of lactating rats, but these results do not always predict what happens in humans. Because of the potential for side effects in a nursing infant, you should talk to your doctor about whether to continue breastfeeding or stop using the medication. The decision will depend on the necessity of the drug for the mother's health and the potential risks to the child.

Dosage Forms

Victoza is supplied as a clear, colorless solution for subcutaneous injection. The medication comes in a pre-filled, disposable delivery pen.

• Injection Pen: A multi-dose, pre-filled device intended for use by a single patient.
• Administration: The solution is injected into the fatty tissue under the skin of the abdomen, thigh, or upper arm.

The device is used with sterile, disposable needles that are attached before each use and discarded afterward. The pen should not be shared with others, even if the needle is changed.

FDA Approval and Indications

Victoza (liraglutide) was first approved by the U.S. Food and Drug Administration (FDA) in 2010. It is indicated for use alongside diet and exercise to improve blood sugar levels in adults and children 10 years of age and older with type 2 diabetes mellitus. Additionally, it is approved for adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, such as heart attack, stroke, or cardiovascular death.

Boxed Warning

The FDA requires a boxed warning for Victoza because liraglutide has been shown to cause thyroid C-cell tumors in animal studies. It is unknown whether Victoza causes these tumors in humans. Patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) are advised not to use this medication.

Generic Availability

In June 2024, the FDA approved the first generic version of liraglutide injection. This generic is approved for the same indications as the brand-name drug to help lower blood sugar in patients with type 2 diabetes.

Safety Monitoring and REMS

The FDA previously required a Risk Evaluation and Mitigation Strategy (REMS) for Victoza to ensure healthcare providers were informed about the potential risks of medullary thyroid carcinoma and acute pancreatitis. The FDA continues to monitor post-marketing safety data regarding these risks and other potential adverse effects.

Weight Loss and Victoza

Victoza is primarily indicated for the treatment of type 2 diabetes and the reduction of cardiovascular risk. While it is not FDA-approved as a weight-loss medication, many people experience a decrease in body weight while taking it. A different brand of the same active ingredient (liraglutide), known as Saxenda, is specifically approved for chronic weight management.

How It Works

Victoza belongs to a class of medications called GLP-1 receptor agonists. It mimics a hormone that occurs naturally in the body to regulate blood sugar and appetite. It contributes to weight loss through several mechanisms:

• Delayed Gastric Emptying: The medication slows the movement of food through the stomach, which helps patients feel full for a longer duration after meals.
• Appetite Suppression: It interacts with the areas of the brain that signal hunger, leading to reduced calorie intake.

Clinical Use

Weight loss seen with Victoza is generally most significant when the medication is used in conjunction with lifestyle modifications, such as a reduced-calorie diet and increased physical activity. Because Victoza is intended for diabetes management, any weight loss is typically monitored by a healthcare provider as part of a broader treatment plan for blood sugar control.