Victoza 6 mg/mL
liraglutide · INJECTION · A-S Medication Solutions
Victoza is a injection containing liraglutide at 6 mg/mL, taken subcutaneous. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Victoza
- Generic Name
- liraglutide
- NDC Code (Product)
50090-4503- Manufacturer
- A-S Medication Solutions
- Strength
- 6 mg/mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA022341
- Drug Class
- GLP-1 Receptor Agonist [EPC]
- Marketing Start
- 01/25/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VICTOZA is indicated: • as an adjunct to diet and exercise to improve glycemic control in patients 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 [see Clinical Studies ( 14.3 )] . Limitations of Use : VICTOZA should not be used in patients with type 1 diabetes mellitus. VICTOZA contains liraglutide and should not be coadministered with other liraglutide-containing products. VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: • as an adjunct to diet and exercise to improve glycemic control in patients 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 : • Not for treatment of type 1 diabetes mellitus. • Should not be coadministered with other liraglutide-containing products.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Inspect visually prior to each injection. Only use if solution is clear, colorless, and contains no particles ( 2.1 ). • Inject VICTOZA subcutaneously once-daily at any time of day, independently of meals, in the abdomen, thigh or upper arm ( 2.1 ). • When using VICTOZA with insulin, administer as separate injections. Never mix. ( 2.1 ). • Adult Dosage: Initiate at 0.6 mg 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 ( 2.2 ). • Pediatric Dosage: Initiate at 0.6 mg 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 ( 2.3 ). 2.1 Important Dosing and 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 abdom…
Contraindications
4 CONTRAINDICATIONS • Medullary Thyroid Carcinoma 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). • Hypersensitivity VICTOZA is contraindicated in patients with a 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 ( 5.6 )]. VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4) . VICTOZA is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or any of the excipients in VICTOZA (4) .
Drug Interactions
7 DRUG INTERACTIONS Oral Medications: VICTOZA delays gastric emptying and may impact absorption of concomitantly administered oral medications ( 7 ). Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin: when initiating, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia ( 7 ). 7.1 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. Nonetheless, caution should be exercised when oral medications are concomitantly administered with VICTOZA. 7.2 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin 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 ) and Adverse Reactions ( 6 )].
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 )] • Pancreatitis [see Warnings and Precautions ( 5.2 )] • Hypoglycemia [see Warnings and Precautions ( 5.4 )] • Renal Impairment [see Warnings and Precautions ( 5.5 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.7 )] • The most common adverse reactions, reported in ≥5% of patients treated with VICTOZA 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 (6.2) . 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. 6.1 Clinical 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 clinic…
Frequently Asked Questions
What is Victoza used for?
Victoza contains liraglutide. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is Victoza a controlled substance?
Victoza is not classified as a controlled substance by the DEA.
What is the generic name for Victoza?
The generic name for Victoza is liraglutide. There are 10 other brand versions of liraglutide.
What is the NDC code for Victoza 6 mg/mL?
The NDC (National Drug Code) for Victoza 6 mg/mL is 50090-4503, listed by A-S Medication Solutions.