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Liraglutide

    DEA Class; Rx

    Common Brand Names; Victoza, Saxenda

    • Antidiabetics, Glucagon-like Peptide-1 Agonists

    Subcutaneous incretin mimetic (GLP-1 receptor agonist); used once daily; not a first-line therapy due to the boxed warning regarding rodent C-cell tumors and the uncertain risk to humans
    Victoza product is used in adult and pediatric patients 10 years and older with type 2 diabetes mellitus (DM) and to reduce the risk of non-fatal and fatal cardiovascular events (e.g., myocardial infarction or stroke) in adults, if these patients also have cardiovascular disease
    Separate product (Saxenda) used for weight reduction and maintenance in obese pediatric patients 12 years and older and obese adults or overweight adults with at least 1 weight-related comorbidity

    Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

    For the reduction of cardiovascular mortality and CV events (e.g., non-fatal myocardial infarction or non-fatal stroke) in type 2 diabetes mellitus patients who also have established CV disease.
    For the treatment of obesity and for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity.

    Hypersensitivity to liraglutide or its components

    Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)

    Saxenda only: Pregnancy

    • Nausea (26%)
    • Diarrhea (17%)
    • Vomiting (11%)
    • Nausea (39.3%)
    • Hypoglycemia in T2DM (23%)
    • Diarrhea (20.9%)
    • Constipation (19.4%)
    • Vomiting (15.7%)
    • Headache (13.6%)
    • Constipation (10%)
    • Headache (9%)
    • Antiliraglutide antibodies (7%)
    • Injection-site reactions (2%)
    • Decreased appetite (10%)
    • Dyspepsia (9.6%)
    • Fatigue (7.5%)
    • Dizziness (6.9%)
    • Abdominal pain (5.4%)
    • Increased lipase (5.3%)
    • Upper abdominal pain (5.1%)
    • Gastroesophageal reflux disease (4.7%)
    • Gastroenteritis (4.7%)
    • Abdominal distension (4.5%)
    • Eructation (4.5%)
    • Urinary tract infection (4.3%)
    • Flatulence (4%)
    • Viral gastroenteritis (2.8%)
    • Injection site erythema (2.5%)
    • Injection site reaction (2.5%)
    • Insomnia (2.4%)
    • Dry mouth (2.3%)
    • Asthenia (2.1%)
    • Anxiety (2%)
    • Urticaria
    • Upper respiratory tract infection
    • UTI
    • Dizziness
    • Sinusitis
    • Nasopharyngitis
    • Back pain
    • Hypertension
    • Hypoglycemia (mostly in combination therapy)
    • Pancreatitis
    • Papillary thyroid carcinoma
    • Thyroid C-cell hyperplasia

    Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed; studied in a limited number of patients with a history of pancreatitis; unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis

    Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and postmarketing; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up indicated

    May cause 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; if serum calcitonin is elevated, evaluate further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

    Renal Impairment reported in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis; altered renal function has been reversed in many of reported cases with supportive treatment and discontinuation of potentially causative agents; use caution when initiating or escalating doses of in these patients

    There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions, angioedema)

    Never share pen between patients even if needle is changed

    Victoza

    • Based on animal reproduction studies, there may be risks to the fetus from exposure during pregnancy
    • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

    Saxenda

    • Contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm
    • There are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage

    There are no data on the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production

    Adults

    1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.

    Geriatric

    1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.

    Adolescents

    1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.

    Children

    12 years: 1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.
    10 to 11 years: 1.8 mg/day for the treatment of type 2 diabetes mellitus; safety and efficacy for the treatment of obesity have not been established; however, doses up to 3 mg/day have been used off-label.
    7 to 9 years: Safety and efficacy have not been established; however, doses up to 3 mg/day have been used off-label for the treatment of obesity.
    1 to 6 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Liraglutide

    SC solution multidose pen

    • 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8mg
    • 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg