Liraglutide Prescribing Information, Explained Section by Section
Liraglutide is sold under 2 labels: Victoza, Saxenda. Each carries the same boxed warning for thyroid C-cell tumors but lists different approved uses.
- Boxed warning
- About thyroid C-cell tumors
- Approved uses
- 2
- Warnings
- 8
- First approved
- 2010
Saxenda in brief
Its half-life is about 13 hours: after 13 h, half is gone, and five half-lives (2.7 d) leave about 3%.
In the SCALE Obesity and Prediabetes, 56 weeks trial, weight loss reached 7.4% of body weight, compared with 3% on placebo.
Sources: FDA label (DailyMed).
The 2 liraglutide labels
| Label | Main approved use | Form | Full label |
|---|---|---|---|
 Victoza | Used with diet and exercise, it lowers blood sugar for adults and children 10 and older who have type 2 diabetes. | daily injection | DailyMed |
 Saxenda | For adults and children with obesity who are 12 and older (over 60 kg), it helps reduce weight and keep it off over time, together with diet and activity. It also applies to adults who have overweight plus a weight-related condition. | daily injection | DailyMed |
Sources: FDA label (DailyMed), FDA label.
Boxed warning for Victoza
Boxed warning: it caused thyroid C-cell tumors in rodents, and whether it does the same in people is not known. People with medullary thyroid cancer (MTC) in their personal or family history must not use it, and the same applies to people with MEN 2.
Words from the label
“Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether VICTOZA causes”
Source: FDA label (DailyMed).
Indications
Used with diet and exercise, it lowers blood sugar for adults and children 10 and older who have type 2 diabetes.
Words from the label
“as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes”
Source: FDA label (DailyMed).
It reduces the chance of heart attack, stroke, or death related to the heart for adults who have both type 2 diabetes and heart disease.
Words from the label
“to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and”
Source: FDA label (DailyMed).
Contraindications
Either medullary thyroid cancer (MTC) in your personal or family history, or MEN 2 itself.
Words from the label
“personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
Source: FDA label (DailyMed).
A serious allergic reaction to liraglutide or to any ingredient in the product that happened in the past.
Words from the label
“serious hypersensitivity reaction to liraglutide or to any of the excipients in VICTOZA. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with”
Source: FDA label (DailyMed).
Warnings and safety precautions
About thyroid C-cell tumors. It caused thyroid C-cell tumors in rodents; whether it does in people is not known. It is not for people who have medullary thyroid cancer (MTC) in their personal or family history, or who have MEN 2.
Words from the label
“Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see Nonclinical Toxicology”
Source: FDA label (DailyMed).
About pancreatitis. It can cause the pancreas to become inflamed. If severe stomach pain does not go away and sometimes reaches your back, stop taking it and get care.
Words from the label
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including liraglutide [see Adverse Reactions”
Source: FDA label (DailyMed).
Blood sugar going too low. Taking it with insulin or a sulfonylurea raises the chance of low blood sugar, so those doses may need to be lowered.
Words from the label
“Adult patients receiving VICTOZA in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. In”
Source: FDA label (DailyMed).
Kidney injury caused by fluid loss. Vomiting or diarrhea can cause fluid loss, which may lead to kidney injury. Report heavy fluid loss and drink fluids.
Words from the label
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with VICTOZA [see Adverse Reactions (6.2)]. The majority”
Source: FDA label (DailyMed).
Severe stomach and gut side effects. Side effects in the stomach and gut are common and may be severe. It is not recommended for people who have severe gastroparesis.
Words from the label
“Use of GLP-1 receptor agonists, including liraglutide, has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In VICTOZA clinical trials, severe”
Source: FDA label (DailyMed).
Allergic reactions can be serious. Reports include serious allergic reactions with swelling of the face, lips or throat. If they occur, stop taking it and get help right away.
Words from the label
“There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with VICTOZA [see Adverse Reactions (6.2)]. If a”
Source: FDA label (DailyMed).
Disease of the gallbladder. Gallstones and inflammation of the gallbladder may occur. Report upper right belly pain, yellow skin or eyes, or fever.
Words from the label
“Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In the LEADER trial [see”
Source: FDA label (DailyMed).
Food reaching the lungs while you are under anesthesia or sedation. Food may stay in the stomach longer, and that matters during anesthesia or deep sedation. Let your care team know before you have any procedure.
Words from the label
“VICTOZA delays gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Table of adverse reactions
In the label trials, side effects seen most often are grouped by dose and shown beside placebo.
| Side effect | Placebo | Victoza 1.2 mg | Victoza 1.8 mg | More than placebo, 1.8 mg |
|---|---|---|---|---|
| Nausea | 5% | 18% | 20% | +15 points |
| Diarrhea | 4% | 10% | 12% | +8 points |
| Headache | 7% | 11% | 10% | +3 points |
| Nasopharyngitis | 8% | 9% | 10% | +2 points |
| Decreased appetite | 1% | 10% | 9% | +8 points |
| Vomiting | 2% | 6% | 9% | +7 points |
| Dyspepsia | 1% | 4% | 7% | +6 points |
| Upper Respiratory Tract Infection | 6% | 7% | 6% | No more than placebo |
| Constipation | 1% | 5% | 5% | +4 points |
| Back Pain | 3% | 4% | 5% | +2 points |
Source: Victoza label (DailyMed).
Interactions with other drugs
The risk of low blood sugar goes up when it is taken together with insulin, or with a sulfonylurea such as glipizide or glimepiride. The doctor may then lower the doses.
Words from the label
“When initiating VICTOZA, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings”
Source: FDA label (DailyMed).
It slows the emptying of the stomach, and that can change how other pills get absorbed.
Words from the label
“VICTOZA causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials,”
Source: FDA label (DailyMed).
Use in pregnancy and breastfeeding
During pregnancy, use it only when the benefit is enough to justify any possible risk to the baby.
Words from the label
“VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Source: FDA label (DailyMed).
Whether it enters human breast milk is not known.
Words from the label
“There are no data on the presence of VICTOZA in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide”
Source: FDA label (DailyMed).
Storage and counselling for patients
Store new pens in the fridge. After the first use, a pen can stay for 30 days in the fridge or at room temperature.
Words from the label
“After first use of the VICTOZA pen, the pen can be stored for 30 days at controlled room temperature 59°F to 86°F (15°C to 30°C)”
Source: FDA label (DailyMed).
How this label compares with other GLP-1 labels
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
 Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
 Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Strong CYP3A4 inhibitors, Strong CYP3A4 inducers, Birth control pills, Simvastatin |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
| Saxenda | Yes | 9 | 2 | Not listed |
| Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Birth control pills and antibiotics, Warfarin and narrow-range drugs |
Sources: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the complete Victoza label
Find the complete prescribing information at DailyMed, the National Library of Medicine label site.