VICTOZA Dosage & Rx Info | Uses, Side Effects

Victoza Generic Name & Formulations

Legal Class

General Description

Liraglutide 6mg/mL; soln for SC inj.

Pharmacological Class

Glucagon-like peptide-1 (GLP-1) receptor agonist.

How Supplied

Multi-dose, pre-filled pens (3mL)—2, 3

Manufacturer

Novo Nordisk

Generic Availability

Mechanism of Action

Liraglutide is an acylated human Glucagon-Like Peptide-1 (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.

Victoza Indications

Indications

As an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). To reduce the risk of major adverse CV events (eg, CV death, non-fatal MI/stroke) in adults with T2DM and established CV disease.

Limitations of Use

Not for treating type 1 diabetes. Should not be coadministered with other liraglutide-containing products.

Victoza Dosage and Administration

Adult

Give by SC inj in abdomen, thigh, or upper arm once daily. Rotate inj sites. Initially 0.6mg/day for 1 week, then increase to 1.2mg/day; may increase to 1.8mg/day after ≥1 week if additional control is required. If >3 days elapsed since last dose, reinitiate at 0.6mg/day, then titrate.

Children

Major CV events: <18yrs: not established. Glycemic control in T2DM:<10yrs: not established. Give by SC inj in abdomen, thigh, or upper arm once daily. Rotate inj sites. ≥10yrs: initially 0.6mg/day; after ≥1 week, may increase to 1.2mg/day if additional control is required; may further increase to 1.8mg/day after ≥1 week if needed. If >3 days elapsed since last dose, reinitiate at 0.6mg/day, then titrate.

Victoza Contraindications

Contraindications

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Victoza Boxed Warnings

Boxed Warning

Risk of thyroid C-cell tumors.

Victoza Warnings/Precautions

Warnings/Precautions

Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. Discontinue if pancreatitis is suspected; do not restart if confirmed. History of pancreatitis: limited data. Do not reuse or share pens between patients, even if the needle is changed. Higher risk of hypoglycemia in pediatrics ≥10yrs old (regardless of insulin and/or metformin use). History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Renal impairment: caution with initiating or escalating doses. Hepatic impairment: use with caution (limited data). Dehydration. Gastroparesis: not studied. Pregnancy. Nursing mothers.

Victoza Pharmacokinetics

Absorption

Maximum concentrations are reached at 8–12 hours post dose. After a single dose of 0.6 mg, the mean peak serum concentration (Cmax) was 35 ng/mL and the mean total exposure (AUC) was 960 ng·h/mL. Cmax and AUC increased proportionally over the dose range of 0.6–1.8 mg. Absolute bioavailability: ~55%.

Distribution

Mean apparent volume of distribution: ~13 L (after SC admin). Mean volume of distribution: 0.07 L/kg (after IV admin). Plasma protein bound: >98%.

Metabolism

Liraglutide is endogenously metabolized without a specific organ as a major route of elimination.

Elimination

Half-life: ~13 hours.

Victoza Interactions

Interactions

Concomitant insulin; administer as separate injections not adjacent to each other. Adults: increased risk of hypoglycemia with sulfonylureas or insulin (consider reducing dose of these). May affect absorption of concomitant oral drugs (delayed gastric emptying); caution.

Victoza Adverse Reactions

Adverse Reactions

Nausea, diarrhea, headache, vomiting, decreased appetite, dyspepsia, constipation, immunogenicity reactions (eg, urticaria); hypoglycemia (esp. in children); rare: pancreatitis, papillary thyroid carcinoma, hypersensitivity reactions.

Victoza Clinical Trials

See Literature

Victoza Note

Not Applicable

Victoza Patient Counseling