Liraglutide

Liraglutide is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes.

1.

1 INDICATIONS AND USAGE Liraglutide injection 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 Limitations of Use: Liraglutide injection contains liraglutide.

Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection 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 ).

Limitations of Use :

Coadministration with other liraglutide-containing products is not recommended.

Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes.

1.

, Geriatrics (>65 years of age). 7 WARNINGS AND PRECAUTIONS, Special Populations, Gastrointestinal disease; 4 DOSAGE AND ADMINISTRATION, Dosing considerations; 10 CLINICAL PHARMACOLOGY, Pharmacodynamics, Gastric emptying) Patients with mild, moderate and severe renal insufficiency (creatinine clearance 60-90 mL/min, 30–59 mL/min and < 30 mL/min respectively) may experience more gastrointestinal effects when treated with liraglutide.

3% in both VICTOZA®-treated and placebo-treated patients. 2% in both VICTOZA®-treated and placebo-treated patients. 8 cases per 1000 patient years of observation) in placebo-treated patients, both on a background of standard of care.

9 cases per 1000 patient years of observation) in placebo- treated patients.

Immunogenicity:

Consistent with the potentially immunogenic properties and peptide pharmaceuticals, patients treated with VICTOZA® may develop anti-liraglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.