Victoza Prescribing Information, Explained Section by Section
The Victoza label carries a boxed warning for thyroid c-cell tumors, 8 other warnings and 2 drug interaction lines. It is approved for 2 uses.
- Boxed warning
- Thyroid C-cell tumors
- Approved uses
- 2
- Warnings
- 8
- First approved
- 2010
Victoza overview
Its half-life is about 13 hours; by 13 h, half is gone, and by five half-lives (2.7 d), about 3% remains.
In LEAD-3, which lasted 52 weeks, people with type 2 diabetes lost 2.5 kg, compared with 1.1 kg among those taking placebo.
Sources: FDA label (DailyMed).
Victoza boxed warning
The boxed warning reports thyroid C-cell tumors in rodents from this drug; whether people develop them remains unknown. You must not take this drug if you have MEN 2, medullary thyroid cancer (MTC), or a family history of medullary thyroid cancer.
The label words
“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
This medicine lowers blood sugar in adults and children 10 and older with type 2 diabetes, alongside diet and exercise.
The label words
“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 lowers the risk of heart attack, stroke, or heart-related death in adults who have type 2 diabetes and heart disease.
The label words
“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
A history of medullary thyroid cancer (MTC) in you or a family member, or MEN 2.
The label words
“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 past serious allergic reaction to liraglutide or any ingredient in this product.
The label words
“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 plus safety precautions
Thyroid C-cell tumors. In rodents, this drug caused thyroid C-cell tumors; whether people get those tumors from it remains unknown. It should not be taken by anyone whose own history or family history includes medullary thyroid cancer (MTC), or who has MEN 2.
The label words
“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).
Pancreatitis. Inflammation in the pancreas. Stop taking it and get medical care if ongoing severe stomach pain sometimes reaches your back.
The label words
“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).
Low blood sugar. Low blood sugar is more likely when you take it with insulin or a sulfonylurea, so those doses may need lowering.
The label words
“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 due to fluid loss. Vomiting or diarrhea may lead to fluid loss, which can result in kidney injury. Drink fluids and report heavy fluid loss.
The label words
“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 reactions. Side effects in the gut and stomach occur often and can be severe. For people who have severe gastroparesis, this drug is not recommended.
The label words
“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 may be serious. Reported serious allergic reactions included swelling of the face, lips, or throat. Stop taking it and seek immediate help if they occur.
The label words
“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).
Gallbladder disease. You may develop gallstones and gallbladder inflammation. Report belly pain in the upper right area, yellow skin or eyes, or a fever.
The label words
“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 can remain in the stomach longer, which matters during anesthesia or deep sedation. Tell the care team before you have any procedure.
The label words
“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).
Adverse reaction table
In the label trials, the most common side effects are listed by dose group next to 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).
Drug interactions
Low blood sugar is more likely when this drug is used with insulin or sulfonylurea medicines such as glipizide or glimepiride.
The label words
“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 delays stomach emptying, which may change how your body takes in other pills.
The label words
“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).
Pregnancy and breastfeeding
During pregnancy, use it only when its benefit is enough to justify possible risk to the baby.
The label words
“VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”
Source: FDA label (DailyMed).
Scientists do not know whether this medicine passes into human breast milk.
The label words
“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 advice for patients
Store new pens in the refrigerator. After you first use a pen, it may remain at room temperature or in the refrigerator for 30 days.
The label words
“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 labels for other GLP-1 medicines
| 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 | Birth control pills, Simvastatin, Strong CYP3A4 inhibitors, plus Strong CYP3A4 inducers |
 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 | Warfarin with narrow-range drugs; Birth control pills when used with antibiotics |
Additional sources include Zepbound label (DailyMed), Foundayo label (DailyMed), and Trulicity label (DailyMed). Further references are Saxenda label (DailyMed), Victoza label (DailyMed), and Byetta label (DailyMed).
Read the complete Victoza label
You can find the complete prescribing information on DailyMed, the National Library of Medicine label site.