Victoza liraglutide 6 mg/mL Injection
Other active recalls for Liraglutide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the GLP-1 Receptor Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Liraglutide injection is used for the following: to control blood sugar levels in certain patients with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). to reduce the risk of a heart attack, stroke, or death in adults with type 2 diabetes and heart and blood vessel disease. to assist with weight loss in certain people who are obese or overweight and have weight-related medical problems. Liraglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount...
Read the full MedlinePlus article ↗- Saxenda is a daily injectable medication that works by mimicking a hormone called GLP-1, which your body naturally makes after eating. It helps reduce your appetite, makes you feel...
- What exactly is Saxenda and how is it different from other weight-loss options?
- Yes, nausea is the most common side effect, and it's especially common in the first few weeks. That's actually why your prescriber starts you at a low dose and slowly increases it...
- The nausea is really bothering me — is that normal, and will it get better?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Liraglutide — tap one for details:
Liraglutide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
5.5 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
-
14 mg / 1 mL
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
1.42 mg / 1 mL
UNII 94255I6E2T
Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $87.742 | $526.45 / 6 ml |
| Medicaid paysCMS SDUD · 12 mo | $88.47 | $530.80 / 6 ml |
| Medicare drug plans payPart D · Q2 2026 | $88.08 | $528.49 / 6 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Liraglutide 6 mg/mL 71288-0563-84 | Meitheal | 3 syringes | $32.002 | AP1 | Availability likely | save 64% |
| Liraglutide 6 mg/mL 00143-9144-02 | Hikma | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| Liraglutide 6 mg/mL 00480-3667-20 | Teva | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| Liraglutide 6 mg/mL 69097-0920-67 | Cipla | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| Liraglutide 6 mg/mL 70377-0094-52 | Biocon | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| Liraglutide 6 mg/mL 70748-0346-02 | Lupin | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| Liraglutide 6 mg/mL 72603-0745-02 | NorthStar | 2 syringes | $33.818 | AP1 | Availability likely | save 61% |
| liraglutide 6 mg/mL 69097-0910-55 | Cipla | 5 syringes | $47.695 | AP2 | Availability likely | save 46% |
| Liraglutide 6 mg/mL 00480-7250-46 | Teva | 5 syringes | $47.695 | AP2 | Availability likely | save 46% |
| Saxenda 6 mg/mL 00169-2800-15 | Novo | 5 syringes | $87.137 | AP2 | Availability likely | save 1% |
| Victoza 6 mg/mLthis 00169-4060-12 | Novo | 2 syringes | $87.742 | AP1 | Availability likely | — |
| Liraglutide 18 mg/3mL 14403-3400-01 | Hybio | 3 ml | — | AP1 | FDA listed | — |
| Victoza 6 mg/mL 50090-2853-00 | A-S | 3 syringes | — | AP1 | FDA listed | — |
| Victoza 6 mg/mL 50090-4503-00 | A-S | 3 syringes | — | AP1 | FDA listed | — |
| Liraglutide 6 mg/mL 50090-7501-00 | A-S | 3 syringes | — | AP1 | FDA listed | — |
| Liraglutide 6 mg/mL 81607-0018-01 | Orbicular | 3 syringes | — | AP1 | FDA listed | — |
| liraglutide 6 mg/mL 81607-0019-01 | Orbicular | 3 syringes | — | AP2 | FDA listed | — |
| Saxenda 6 mg/mL 50090-4257-00 | A-S | 5 syringes | — | AP2 | FDA listed | — |
| Liraglutide 6 mg/mL 70377-0095-52 | Biocon | 3 syringes | — | AP2 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9968659 ↗ | Method of use | U-2313 | Jan 9, 2037 |
| US 8114833 ↗ | Drug substance | — | Aug 13, 2025 |
| US 8114833*PED ↗ | Drug product | — | Feb 13, 2026 |
| US 9968659*PED ↗ | Drug product | — | Jul 9, 2037 |
Is there a generic version of VICTOZA 2-PAK 18 MG/3 ML PEN?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00169-4060-12 You're viewing this | 2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC | $87.74 / mL | $526.45 | 2010-01-25 | Active |
| 00169-4060-13 | 3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC | $87.81 / mL | $790.33 | 2010-01-25 | Active |
| 00169-4060-90 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-90) / 3 mL in 1 SYRINGE, PLASTIC | — | — | 2010-01-25 | Active |
| 00169-4060-99 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-99) / 3 mL in 1 SYRINGE, PLASTIC | — | — | 2015-02-13 | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($87.74 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 55% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00169-4060-12?
What NDC number is used to bill for this package of Victoza liraglutide 6 mg/mL Injection?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK OF THYROID C-CELL TUMORS • 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 thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )]. • VICTOZA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Counsel patients regarding the potential risk for MTC with the use of VICTOZA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with VICTOZA [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.
It is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). • VICTOZA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VICTOZA is indicated: • 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 mellitus, • 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 established cardiovascular disease. Limitations of Use: VICTOZA contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.
VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: • 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 mellitus. (1) • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) Limitations of Use : • Coadministration with other liraglutide-containing products is not recommended.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Adult Patients : Initiate at 0.6 mg injected subcutaneously once daily for one week then increase to 1.2 mg daily. If additional glycemic control is required, increase the dose to 1.8 mg daily after one week of treatment with the 1.2 mg daily dose. ( 2.1 ) • Pediatric Patients : Initiate at 0.6 mg injected subcutaneously once daily for at least one week.
If additional glycemic control is required increase the dose to 1.2 mg daily and if additional glycemic control is still required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. ( 2.1 ) • Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles.
( 2.3 ) • Inject VICTOZA subcutaneously once-daily at any time of day, independently of meals, in the abdomen, thigh or upper arm. ( 2.3 ) • When using VICTOZA with insulin, administer as separate injections. Never mix.
( 2.3 )
2.1Recommended Dosage Adult Patients • The recommended starting dosage of VICTOZA is 0.6 mg injected subcutaneously once daily for one week. The 0.6 mg once daily dosage is intended to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] during initial titration and is not effective for glycemic control in adults. • After one week at the 0.6 mg once daily dosage, increase the dosage to 1.2 mg injected subcutaneously once daily. • If additional glycemic control is required, increase the dosage to the maximum recommended dosage of 1.8 mg injected subcutaneously once daily after at least one week of treatment with the 1.2 mg once daily dosage.
Pediatric Patients Aged 10 Years and Older • The recommended starting dosage of VICTOZA is 0.6 mg injected subcutaneously once daily. • If additional glycemic control is required, increase the dosage in 0.6 mg increments after at least one week on the current dosage, to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] . • The maximum recommended dosage is 1.8 mg injected subcutaneously once daily.
2.2Recommendations Regarding Missed Dose • Instruct patients who miss a dose of VICTOZA to resume the once daily dosage regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose. • If more than 3 days have elapsed since the last VICTOZA dose, reinitiate VICTOZA at 0.6 mg once daily to reduce the risk of gastrointestinal adverse reactions associated with reinitiation of treatment. Upon reinitiation, VICTOZA should be titrated at the discretion of the healthcare provider.
2.3Important Administration Instructions • Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles. • Inject VICTOZA subcutaneously once daily at any time of day, independently of meals. • Inject VICTOZA subcutaneously in the abdomen, thigh or upper arm. No dosage adjustment is needed if changing the injection site and/or timing. • Rotate injection sites within the same region in order to reduce the risk of cutaneous amyloidosis [see Adverse Reactions ( 6.2 )]. • When using VICTOZA with insulin, administer as separate injections.
Never mix. It is acceptable to inject VICTOZA and insulin in the same body region but the injections should not be adjacent to each other.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 18 mg/3 mL (6 mg/mL) clear, colorless solution in a prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg. Injection: 6 mg/mL solution in a prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS VICTOZA is contraindicated in patients with a: • personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . • 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 VICTOZA [see Warnings and Precautions ( 5.7 )]. • Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.
(4) • Patients with a serious hypersensitivity reaction to liraglutide or any of the excipients in VICTOZA. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including VICTOZA. Discontinue if pancreatitis is suspected. ( 5.2 ) • Never Share a VICTOZA Pen Between Patients , even if the needle is changed.
(5.3) • Hypoglycemia : Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with VICTOZA regardless of insulin and/or metformin use. Reduction in the dose of insulin secretagogues or insulin may be necessary.
(5.4) • Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. (5.5) • Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. VICTOZA is not recommended in patients with severe gastroparesis.
( 5.6 ) • Hypersensitivity Reactions : Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue VICTOZA and promptly seek medical advice. (5.7) • Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
(5.8) • Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 )
5.1Risk of Thyroid C-cell Tumors 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 ( 13.1 )] . Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether VICTOZA will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
Cases of MTC in patients treated with VICTOZA have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and VICTOZA use in humans. VICTOZA is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of VICTOZA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with VICTOZA. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L.
If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
5.2Acute Pancreatitis 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 ( 6 )] . After initiation of VICTOZA, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue VICTOZA and initiate appropriate management.
5.3Never Share a VICTOZA Pen Between Patients VICTOZA pens must never be shared between patients, even if the needle…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Hypoglycemia [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] • Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation.
(6.1) • Immunogenicity-related events, including urticaria, were more common among VICTOZA-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. (12.6) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-877-484-2869 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common Adverse Reactions The safety of VICTOZA in patients with type 2 diabetes mellitus was evaluated in 5 glycemic control, placebo-controlled trials in adults and one trial of 52 weeks duration in pediatric patients 10 years of age and older [see Clinical Studies ( 14.1 )] .
The data in Table 1 reflect exposure of 1,673 adult patients to VICTOZA and a mean duration of exposure to VICTOZA of 37.3 weeks. The mean age of adult patients was 58 years, 4% were 75 years or older and 54% were male. The population was 79% White, 6% Black or African American, 13% Asian; 4% were of Hispanic or Latino ethnicity.
At baseline the population had diabetes for an average of 9 years and a mean HbA 1c of 8.4%. Baseline estimated renal function was normal or mildly impaired in 88% and moderately impaired in 12% of the pooled population. Table 1 shows common adverse reactions in adults, excluding hypoglycemia, associated with the use of VICTOZA for the treatment of type 2 diabetes mellitus.
These adverse reactions occurred more commonly on VICTOZA than on placebo and occurred in at least 5% of patients treated with VICTOZA. Overall, the type, and severity of adverse reactions in pediatric patients 10 years of age and older and above were comparable to that observed in the adult population. Table 1.
Adverse reactions reported in ≥5% of Adult Patients Treated with VICTOZA for Type 2 Diabetes Mellitus Placebo N=661 Liraglutide 1.2 mg N= 645 Liraglutide 1.8 mg N= 1024 Adverse Reaction (%) (%) (%) Nausea 5 18 20 Diarrhea 4 10 12 Headache 7 11 10 Nasopharyngitis 8 9 10 Vomiting 2 6 9 Decreased appetite 1 10 9 Dyspepsia 1 4 7 Upper Respiratory Tract Infection 6 7 6 Constipation 1 5 5 Back Pain 3 4 5 Cumulative proportions were calculated combining studies using Cochran-Mantel-Haenszel weights. In an analysis of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1 .
Other Adverse Reactions Gastrointestinal Adverse Reactions In the pool of 5 glycemic control, placebo-controlled adult clinical trials, withdrawals due to gastrointestinal adverse reactions, occurred in 4.3% of VICTOZA-treated patients and 0.5% of placebo-treated patients. Severe gastrointestinal adverse reactions were reported more frequently among patients receiving VICTOZA (1.2 mg 4.4%, 1.8 mg 4.2%) than placebo (1.1%). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2 to 3 months of the trials.
Injecti…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Effects of delayed gastric emptying on oral medications: VICTOZA delays gastric emptying and may impact absorption of concomitantly administered oral medications. ( 7 )
7.1Effects of Delayed Gastric Emptying on Oral Medications 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, VICTOZA did not affect the absorption of the tested orally administered medications to any clinically relevant degree [see Clinical Pharmacology ( 12.3 )] . Nonetheless, caution should be exercised when oral medications are concomitantly administered with VICTOZA.
7.2Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin VICTOZA stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving VICTOZA in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. 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 and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 )
8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA during pregnancy. VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy.
Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data) . The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes (Hemoglobin A 1c >7) is 6 to 10%.
The major birth defect rate has been reported to be as high as 20 to 25% in women with a Hemoglobin A 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Animal Data Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the human exposure at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly.
Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day.
Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the human exposure at the MRHD of 1.8 mg/day at all doses, based on plasma AUC. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), ≥0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), ≥0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels).
Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. Visceral abnormalities occurred in blood vessels, lung, liver, and esophagus. Bilobed or bifurcated gallbladder was seen in all treatment groups, but not in the control group.
In pregnant female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide from gestation day 6 through weaning or termination of nursing on lactation day 24, estimated systemic exposures were 0.8-, 3-, and 11-times human exposure…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA during pregnancy. VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy.
Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data) . The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes (Hemoglobin A 1c >7) is 6 to 10%.
The major birth defect rate has been reported to be as high as 20 to 25% in women with a Hemoglobin A 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Animal Data Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the human exposure at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly.
Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day.
Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the human exposure at the MRHD of 1.8 mg/day at all doses, based on plasma AUC. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), ≥0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), ≥0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels).
Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. Visceral abnormalities occurred in blood vessels, lung, liver, and esophagus. Bilobed or bifurcated gallbladder was seen in all treatment groups, but not in the control group.
In pregnant female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide from gestation day 6 through weaning or termination of nursing on lactation day 24, estimated systemic exposures were 0.8-, 3-, and 11-times human exposure at the MRHD of 1.8 mg/day, based on plasma AUC. A slight delay in parturition was observed in the majority of treated rats. Group mean body weight of neonatal ra…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of VICTOZA as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years of age with type 2 diabetes mellitus, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.1 , 14.2 )] .
The risk of hypoglycemia was higher with VICTOZA in pediatric patients regardless of insulin and/or metformin use [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of VICTOZA have not been established in pediatric patients less than 10 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use In the VICTOZA treatment arms of the glycemic control trials, a total of 832 (19.3%) of the patients were 65 to 74 years of age and 145 (3.4%) were 75 years of age and over [see Clinical Studies ( 14.1 )] . In the VICTOZA treatment arm of the LEADER trial [see Clinical Studies ( 14.3 )] , a total of 1738 (37.2%) patients were 65 to 74 years of age, 401 (8.6%) were 75 to 84 years of age, and 17 (0.4%) were 85 years of age or older at baseline. No overall differences in safety or effectiveness for VICTOZA have been observed between patients 65 years of age and older and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of VICTOZA. Observed effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdosage, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Initiate appropriate supportive treatment according to the patient’s clinical signs and symptoms.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). GLP-1(7-37) represents <20% of total circulating endogenous GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells.
Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner.
The mechanism of blood glucose lowering also involves a delay in gastric emptying. GLP-1(7-37) has a half-life of 1.5 to 2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration.
The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-4 and NEP.
12.2Pharmacodynamics VICTOZA’s pharmacodynamic profile is consistent with its pharmacokinetic profile observed after single subcutaneous administration as VICTOZA lowered fasting, premeal and postprandial glucose throughout the day [see Clinical Pharmacology ( 12.3 )] . Fasting and postprandial glucose was measured before and up to 5 hours after a standardized meal after treatment to steady state with 0.6, 1.2 and 1.8 mg VICTOZA or placebo. Compared to placebo, the postprandial plasma glucose AUC 0-300min was 35% lower after VICTOZA 1.2 mg and 38% lower after VICTOZA 1.8 mg.
Glucose-dependent insulin secretion The effect of a single dose of 7.5 mcg/kg (~0.7 mg) VICTOZA on insulin secretion rates (ISR) was investigated in 10 patients with type 2 diabetes mellitus during graded glucose infusion. In these patients, on average, the ISR response was increased in a glucose-dependent manner ( Figure 2 ). Figure 2.
Mean Insulin Secretion Rate (ISR) versus Glucose Concentration Following Single-Dose VICTOZA 7.5 mcg/kg (~ 0.7 mg) or Placebo in Patients with Type 2 Diabetes Mellitus (N=10) During Graded Glucose Infusion Glucagon secretion VICTOZA lowered blood glucose by stimulating insulin secretion and lowering glucagon secretion. A single dose of VICTOZA 7.5 mcg/kg (~0.7 mg) did not impair glucagon response to low glucose concentrations. Gastric emptying VICTOZA causes a delay of gastric emptying, thereby reducing the rate at which postprandial glucose appears in the circulation.
Cardiac Electrophysiology (QTc) The effect of VICTOZA on cardiac repolarization was tested in a QTc study. VICTOZA at steady state concentrations with daily doses up to 1.8 mg did not produce QTc prolongation. figure-2
12.3Pharmacokinetics Absorption Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 8 to 12 hours post dosing. The mean peak (C max ) and total (AUC) exposures of liraglutide were 35 ng/mL and 960 ng·h/mL, respectively, for a subcutaneous single dose of 0.6 mg. After subcutaneous single dose administrations, C max and AUC of liraglutide increased proportionally over the therapeutic dose range of 0.6 mg to 1.8 mg.
At 1.8 mg VICTOZA, the average steady state concentration of liraglutide over 24 hours was approximately 128 ng/mL. AUC 0-∞ was equivalent between upper arm and abdomen, and between upper arm and thigh. AUC 0-∞ from thigh was 22% lower than that from abdomen.
However, liraglutide exposures were considered comparable among these three subcutaneous injection sites. Absolute bioavailability of liraglutide following subcutaneo…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). GLP-1(7-37) represents <20% of total circulating endogenous GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells.
Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a glucose-dependent manner.
The mechanism of blood glucose lowering also involves a delay in gastric emptying. GLP-1(7-37) has a half-life of 1.5 to 2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration.
The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-4 and NEP.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied VICTOZA Injection: 18 mg/3 mL (6 mg/mL) clear, colorless solution in a prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg is available in the following package sizes: 2 x VICTOZA pen NDC 0169-4060-12 3 x VICTOZA pen NDC 0169-4060-13 Recommended Storage Prior to first use, VICTOZA should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze VICTOZA and do not use VICTOZA if it has been frozen.
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) or in a refrigerator 36°F to 46°F (2°C to 8°C). Keep the pen cap on when not in use. Protect VICTOZA from excessive heat and sunlight.
Always remove and safely discard the needle after each injection and store the VICTOZA pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy. Always use a new needle for each injection to prevent contamination.
📋 Description ▾
11 DESCRIPTION VICTOZA contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.
The molecular formula of liraglutide is C 172 H 265 N 43 O 51 and the molecular weight is 3751.2 Daltons. The structural formula ( Figure 1 ) is: Figure 1. Structural Formula of liraglutide VICTOZA injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use.
Each 1 mL of VICTOZA solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. VICTOZA has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of VICTOZA equivalent to 18 mg liraglutide (free-base, anhydrous). structural-formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Thyroid C-cell Tumors Inform patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that the human relevance of this finding is unknown. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue VICTOZA promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )]. Never Share a VICTOZA Pen Between Patients Advise patients that they must never share a VICTOZA pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.3 )] .
Hypoglycemia Inform patients that hypoglycemia has been reported when VICTOZA is used with insulin secretagogues or insulin and may occur in pediatric patients regardless of concomitant antidiabetic treatment. Educate patients or caregivers on the signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.4 )] . Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions.
Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.5 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions.
Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.6 )] . Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of VICTOZA. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking VICTOZA and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.7 )] .
Acute Gallbladder Disease Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that VICTOZA may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.
Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking VICTOZA [see Warnings and Precautions ( 5.9 )]. Missed Dose Inform patients not to take an extra dose of VICTOZA to make up for a missed dose. If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose.
If more than 3 days have elapsed since the last dose, advise the patient to reinitiate VICTOZA at 0.6 mg to mitigate any gastrointestinal symptoms associated with reinitiation of treatment. VICTOZA should be titrated at the discretion of the healthcare provider [see Dosage and Administration ( 2.2 )]. Marketed by: Novo Nordisk Inc.
Plainsboro, NJ 08536 VICTOZA ® is a registered trademark of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html © 2025 Novo Nordisk For information about VICTOZA contact: Novo Nordisk…
💬 Medication Guide ▾
Medication Guide VICTOZA ® (VIC-tow-za) (liraglutide) injection, for subcutaneous use Read this Medication Guide before you start using VICTOZA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
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 healthcare 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. • 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 VICTOZA? VICTOZA is an injectable prescription medicine used: • along with diet and exercise to improve blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus. • to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. • VICTOZA is not recommended for people who take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. • It is not known if VICTOZA is safe and effective to lower blood sugar (glucose) in children under 10 years of age.
Who should not use VICTOZA? 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). • you have had a serious allergic reaction to liraglutide or any of the ingredients in VICTOZA. See the end of this Medication Guide for a complete list of ingredients in VICTOZA.
See “ What are the possible side effects of VICTOZA? ” for symptoms of a serious allergic reaction. What should I tell my healthcare provider before using VICTOZA? Before using VICTOZA, tell your healthcare provider if you have any other medical conditions, including if you: • have or have had problems with your pancreas. • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. • are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). • are pregnant or plan to become pregnant.
It is not known if VICTOZA will harm your unborn baby. Tell your healthcare provider if you become pregnant while using VICTOZA. • are breastfeeding or plan to breastfeed. It is not known if VICTOZA passes into your breast milk.
You should talk with your healthcare provider about the best way to feed your baby while using VICTOZA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VICTOZA may affect the way some medicines work and some medicines may affect the way VICTOZA works.
Before using VICTOZA, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas. Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use VICTOZA? • Read the Instructions for Use that comes with VICTOZA. • Use VICTOZA exactly as your healthcare provider tells you to. • Your healthcare provider should show you how to use VICTOZA before you u…